Department of Health and Human Services 2013 – Federal Register Recent Federal Regulation Documents
Results 1,201 - 1,250 of 3,929
Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.'' This draft guidance provides recommendations to sponsors on the parameters that should be routinely assessed in toxicology studies for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) regulated by the Center for Drug Evaluation and Research to determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses factors to consider in determining the need for additional studies to characterize potential endocrine disruptor properties of a drug.
Announcement of Requirements and Registration for “System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies Ideation Challenge”
The ``System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies'' Ideation Challenge seeks ideas to establish a system for monitoring the location and status of life-sustaining durable medical equipment (DME) during a prolonged power outage or disaster situation. This information would be used by a network of family and friends, formal caregivers, emergency responders and others responding to a disaster to better assist individuals who are dependent on DME. The current Challenge focuses on obtaining information about DME; however, this is part of a larger effort to ensure that these people get the necessary help as quickly as possible. Submissions can be existing applications, or applications developed specifically for this challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of its Rural Health Clinic Accreditation Program
This proposed notice acknowledges the receipt of an application from the Compliance Team for initial recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
World Trade Center Health Program; Addition of Prostate Cancer to the List of WTC-Related Health Conditions
On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. In this final rule, the Administrator adds malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.
Request for Comments on Pediatric Planned Procedure Algorithm
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. This effort includes development of several new pediatric quality measures, including a pediatric readmission measure. The Agency for Healthcare Research and Quality (AHRQ) is requesting comments from the public on an algorithm for identifying pediatric planned procedures as part of the readmission measure. The purpose of the algorithm is to identify, using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes, pediatric procedures that are usually planned so that admissions for these procedures can be excluded from calculations of readmission rates. To identify planned procedures, expert pediatric clinicians in 14 different procedure-oriented specialties reviewed procedures typically performed by their specialty. The reviewers indicated which procedures (1) are usually planned (defined as planned in more than 80% of cases) and (2) could require hospitalization. Admissions for which the primary procedure coded was one of these procedures are excluded from the count of readmissions. The list of ICD-9-CM codes and code descriptions for the planned procedures is available at: https://www.ahrq.gov/policymakers/chipra/ pedprocedurecodes.html.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with 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 that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medicaid Program; State Disproportionate Share Hospital Allotment Reductions
The statute, as amended by the Affordable Care Act, requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020. This final rule delineates a methodology to implement the annual reductions for FY 2014 and FY 2015. The rule also includes additional DSH reporting requirements for use in implementing the DSH health reform methodology.
Distribution of Reference Biological Standards and Biological Preparations
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on July 22, 2013 (78 FR 43817).
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
The Food and Drug Administration (FDA or we) 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 invites comments on the information collection provisions of reporting and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers, and provides notice of and invites comments on our proposed revisions to the electronic submission system and paper-based forms for this collection.
Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies; Public Meetings
The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern, prevention- oriented food safety practices called for by the Food Safety Modernization Act (FSMA) and achieving the same level of food safety as domestic growers and processors. The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies would strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains. The purpose of these public meetings is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. This guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' The recommendations in the draft guidance are intended to help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
Meeting of the Community Preventive Services Task Force
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonfederal, and uncompensated panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness and health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. During this meeting, the Task Force will consider the findings of systematic reviews on existing research and issue recommendations. These recommendations provide evidence-based options from which decision makers in communities, companies, health departments, health plans and healthcare systems, non-governmental organizations, and at all levels of government can choose what best meets the needs, preferences, available resources, and constraints of their constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Scientific Information Request on Medication Therapy Management
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on medication therapy management Scientific information is being solicited to inform our review of Medication Therapy Management, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on medication therapy management will improve the quality of this review. AHRQ is conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 28th, 2013 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug: Patent Submission and Listing Requirements
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.
Oral Dosage Form New Animal Drugs; Amprolium; Meloxicam
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during August 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Wm. Wrigley Jr. Company; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to expand the use of synthetic iron oxide to include soft and hard candy, mints, and chewing gum. The petition also proposes to lower the specification limit for lead in synthetic iron oxide for human food use.
Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
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.
Submission for OMB Review; 30-day Comment Request: Family Life, Activity, Sun, Health, and Eating (FLASHE) Study (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 June 28, 2013, Vol. 78, No. 125, page 28996 and allowed 60- days for public comment. One public comment was received on June 29, 2013 which commented on the expense and topic of the study. An email response was sent on July 8, 2013 stating ``Your comments will be taken into consideration. The Division of Cancer Prevention at the NCI supports research that studies the potential impact from a cell, tissue or organism and the pathways associated with disease process.'' 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. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Linda Nebeling, Ph.D., Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Room 3E102, Bethesda, MD 20892-9671 or call non-toll-free number 240-276-6855 or Email your request, including your address to: nebelinl@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Family Life, Activity, Sun, Health, and Eating (FLASHE) Study (NCI), 0925-NEW, Expiration Date xx/xx/xxxx, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The FLASHE study seeks to examine psychosocial, generational (parent-adolescent), and environmental correlates of cancer preventive behaviors. FLASHE will examine the science of cancer and obesity prevention by examining correlates of cancer preventive behaviors, mainly diet, activity, and sedentary behaviors (but also examining other behaviors such as sleep, sun-safety, and tobacco) in new ways not previously addressed comprehensively on other surveys. The survey's goal is to advance understanding of the dynamic relationship between the environment, psychosocial factors, and behavior from a dyadic perspective. Data collected will ultimately be a public use dataset and resource to the research community. FLASHE will be collecting data from parents and their adolescent children through a web survey with a final sample size of 2,500 dyads with motion sensing data collected in a subsample of 900 adolescents. OMB approval is requested for 2 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,243.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with 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 an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extension of the approved information collection assigned OMB control number OS-0990-0323, which expires on 30 April 2014. Prior to submitting that 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 for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
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.
Announcement of the Award of Three Single-Source Program Expansion Supplement Grants to National Human Trafficking Victim Assistance Program Grantees
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of expansion supplement grants to the following current grantees for a total of $350,000:
Announcement of the Award of 15 Single-Source Program Expansion Supplement Grants to Unaccompanied Alien Children's Shelter Care Grantees
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of 15 single-source program expansion supplement grants to the following 12 current grantees, for a total of $1,420,955. Two grantees are receiving multiple supplement grants: BCFS Health and Human Services, San Antonio, TX$492,123 and $313,916 totaling $806,039; and International Education Services, Los Fresnos, TX$35,433, $15,486, and $76,698 totaling $127,617.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
