Department of Health and Human Services February 2015 – Federal Register Recent Federal Regulation Documents
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Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.'' This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be provided for regulatory evaluation of a digital whole slide imaging (WSI) system. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
The Food and Drug Administration (FDA or we) 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 (the PRA).
Submission for OMB Review; 30-Day Comment Request Division of Cancer Epidemiology and Genetics (DCEG) Fellowship Program and Summer Student Applications (NCI)
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 on April 9, 2014 (Vol. 79, P. 19632) 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 Cancer Institute (NCI), 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. 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.
Submission for OMB Review; 30-Day Comment Request; Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (NCI)
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 on July 8, 2014, Vol. 79, page 38542 and allowed 60-days for public comment. One public comment was received on July 9, 2014. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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. 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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: CMS-Identified Overpayments Associated With Submitted Payment Data; Corrections
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 10, 2014, entitled ``Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: CMS-Identified Overpayments Associated with Submitted Payment Data.''
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
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 Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0422, scheduled to expire on August 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #229) entitled ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle.'' The purpose of this document is to provide recommendations to industry relating to study design and describe criteria the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of new animal drugs that are intended to reduce pathogenic Shiga toxin-producing E. coli (STEC) in cattle.
Medical Devices; Physical Medicine Devices; Classification of the Powered Exoskeleton
The Food and Drug Administration (FDA) is classifying the powered exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish; Closure of the Public Comment Period
On June 11, 2014, the Food and Drug Administration (FDA), in coordination with the U.S. Environmental Protection Agency (EPA), (the Agencies), released for public comment draft fish consumption advice entitled ``Fish: What Pregnant Women and Parents Should Know.'' The draft advice would update the Agencies' consumption advice and recommend that women who are pregnant (or might become pregnant) or nursing and anyone who prepares food for young children eat certain amounts and types of fish in order to improve health and developmental outcomes while minimizing risk from methylmercury in fish. The draft advice is consistent with recommendations in the Dietary Guidelines for Americans 2010, which are issued every 5 years by the U.S. Departments of Agriculture and Health and Human Services. FDA and EPA are now announcing the closure of the public comment period.
Partnership To Develop the Branded Food Products Database for Public Health (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Agricultural Technology Innovation Partnership's (ATIP) Branded Food Products Database for Public Health. ATIP, in conjunction with the U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) and the International Life Science Institute North America (ILSI North America), has established a public-private partnership to enhance the public's health. The Office of Foods and Veterinary Medicine (OFVM) has grant funds available to help support ATIP consolidate food composition data from manufacturers. OFVM's goal is to monitor the sodium content of branded foods and to make nutrient composition data available to the public.
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Correction
The Food and Drug Administration is correcting a notice entitled ``Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting'' that appeared in the Federal Register of February 6, 2015 (80 FR 6731). The document announced a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The document was published with the incorrect docket number. This document corrects that error.
Basic Health Program; Federal Funding Methodology for Program Year 2016
This document provides the methodology and data sources necessary to determine federal payment amounts made in program year 2016 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Uniform Project Description (UPD) Project Narrative Format for Discretionary Grant Application Forms; Correction
The Administration for Children and Families published a document in the Federal Register of February 17, 2015, concerning a request for comments on a proposed information collection. The document contained an incorrect citation.
Medicare and Medicaid Program; Continued Approval of the Joint Commission's Psychiatric Hospital Accreditation Program
This final notice announces our decision to approve the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs. A psychiatric hospital that participates in Medicaid must also meet the Medicare conditions of participation (CoPs) as required by statute.
Announcement of the Availability of the Scientific Report of the 2015 Dietary Guidelines Advisory Committee, Solicitation of Written Comments on the Advisory Report, and Invitation for Oral Testimony at a Public Meeting
The Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) (a) announce the availability of the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (Advisory Report); (b) solicit written comments on the Advisory Report; and (c) provide notice of a public meeting to solicit oral comments from the public on the Advisory Report.
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.
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.
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271'' dated February 2015. The draft guidance document is intended to provide manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/ Ps) for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The draft guidance, when finalized, is intended to supplement section XXII of FDA's guidance entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011 and supersede the guidance entitled ``Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated November 2005.
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