Department of Health and Human Services July 2013 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 316
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2013-17917
Type: Notice
Date: 2013-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-17916
Type: Notice
Date: 2013-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-17878
Type: Notice
Date: 2013-07-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2013-17868
Type: Notice
Date: 2013-07-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-17867
Type: Notice
Date: 2013-07-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
Document Number: 2013-17835
Type: Notice
Date: 2013-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Turtles Intrastate and Interstate Requirements
Document Number: 2013-17752
Type: Proposed Rule
Date: 2013-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches to remove procedures for destruction as FDA believes it is not necessary to routinely demand this destruction to achieve the purpose of the regulations. This action would reduce the need for investigator training and the time for the care and humane destruction of these animals.
Turtles Intrastate and Interstate Requirements
Document Number: 2013-17751
Type: Rule
Date: 2013-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches to remove procedures for destruction as FDA believes it is not necessary to routinely demand this destruction to achieve the purpose of the regulations. This action will reduce the need for investigator training and the time for the care and humane destruction of these animals.
Tribal Self-Governance
Document Number: 2013-17859
Type: Rule
Date: 2013-07-24
Agency: Department of Health and Human Services, Public Health Service
Designation of Health Professional(s) Shortage Areas
Document Number: 2013-17858
Type: Rule
Date: 2013-07-24
Agency: Department of Health and Human Services, Public Health Service
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-17821
Type: Notice
Date: 2013-07-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Menthol in Cigarettes, Tobacco Products; Request for Comments
Document Number: 2013-17805
Type: Proposed Rule
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the potential regulation of menthol in cigarettes. FDA is also making available its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. The preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes. This ANPRM is seeking comments, including comments on FDA's preliminary evaluation, and data, research, or other information that may inform regulatory actions FDA might take with respect to menthol in cigarettes.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-17799
Type: Notice
Date: 2013-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-17798
Type: Notice
Date: 2013-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Vaccine Injury Compensation Program
Document Number: 2013-17786
Type: Proposed Rule
Date: 2013-07-24
Agency: Department of Health and Human Services
The Secretary has made findings as to intussusceptions that can reasonably be determined in some circumstances to be caused or significantly aggravated by rotavirus vaccines. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will apply only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.
Third Annual Food and Drug Administration Health Professional Organizations Conference
Document Number: 2013-17769
Type: Notice
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability
Document Number: 2013-17768
Type: Notice
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' This draft guidance describes FDA's policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This draft guidance further describes the procedures for making these requests and the criteria that FDA will consider in granting such requests.
New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection
Document Number: 2013-17754
Type: Rule
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co.
Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers With Outdoor Access); Availability
Document Number: 2013-17750
Type: Proposed Rule
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)'' (the draft guidance). The document provides guidance to egg producers on certain provisions contained in FDA's final rule entitled, ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' concerning the management of production systems that provide laying hens with access to the outdoors. Laying hens are provided outdoor access in some production systems, including certified organic production systems governed by the U.S. Department of Agriculture's National Organic Program regulations.
Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers; Availability
Document Number: 2013-17747
Type: Notice
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance to industry entitled ``Providing Submissions in Electronic FormatPostmarket Non-Expedited ICSRs; Technical Questions and Answers.'' The guidance provides firms with information on the appropriate electronic file format to use when electronically submitting to FDA postmarket non-expedited individual case safety reports (ICSRs) on adverse drug experiences.\1\ The guidance explains that firms that had previously submitted non-expedited ICSRs in an electronic format that is not supported by FDA should contact the Center for Drug Evaluation and Research (CDER) or Center for Biologics and Evaluation and Research (CBER) and resubmit their non-expedited ICSRs in a compatible electronic format.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17740
Type: Notice
Date: 2013-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17739
Type: Notice
Date: 2013-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17738
Type: Notice
Date: 2013-07-24
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Sickle Cell Disease Treatment Demonstration Program
Document Number: 2013-17720
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA currently has nine programs that are funded through competitive grant awards under the Sickle Cell Disease Treatment Demonstration Program. Three of these awards will end on August 31, 2013, prior to the end of the other six awards. HRSA intends to implement a non-competitive extension of the project period for the three grants that will end in 2013. This will allow improved data gathering from each of the grantees in the program, which will be used in a report for Congress that is mandated by the legislation authorizing the grant. In addition, the program will benefit from cost savings realized from having the program completed in a consolidated funding cycle.
National Cancer Institute; Notice of Meeting
Document Number: 2013-17718
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-17697
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-17696
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-17695
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-17694
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-17693
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Interest Rate on Overdue Debts
Document Number: 2013-17683
Type: Notice
Date: 2013-07-23
Agency: Department of Health and Human Services, Office of the Secretary
Agency Information Collection Activities; Proposed Collection; Comment Request: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, National Institute of Neurological Disorders and Stroke (NINDS)
Document Number: 2013-17646
Type: Notice
Date: 2013-07-23
Agency: Department of Health and Human Services, National Institutes of Health
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the National Institute of Neurological Disorders (NINDS) has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
Proposed Collection; 60-Day Comment Request: Application for the Postdoctoral Research Associate Program
Document Number: 2013-17645
Type: Notice
Date: 2013-07-23
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing or request more information on the proposed project, contact Ms. Tammy Dean-Maxwell, NIGMS, NIH, Natcher Building, Room 3AN.44, 45 Center Drive, MSC 6200, Bethesda, MD 20892-6200, or call non-toll-free number 301-594-2755 or email your request, including your address to: deanmat@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Proposed Collection: Application for the Postdoctoral Research Associate Program, (NIGMS) Extension of a currently approved collection, OMB No. 0925-0378, expiration date September 30, 2013. Form Numbers: NIH 2721-1, NIH 2721-2. Need and Use of Information Collection: The Postdoctoral Research Associate (PRAT) Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with an appropriate terminal degree who are seeking training in an NIGMS designated emerging area of science, through appointments as PRAT Fellows at the National Institutes of Health or the Food and Drug Administration. The goal of the program is to develop leaders in designated emerging areas of biomedical research for key positions in academic, industrial, and Federal research laboratories. Frequency of Response: Once a year. Affected Public: Individuals or households; businesses or other for- profit. Type of Respondents: Applicants and referees. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 331.
Submission for OMB review; 30-day Comment Request: National Cancer Institute (NCI) Cancer Nanotechnology Platform Partnership Scientific Progress Reports
Document Number: 2013-17644
Type: Notice
Date: 2013-07-23
Agency: Department of Health and Human Services, National Institutes of Health
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 May 13, Vol. 78, p. 27974 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. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Dorothy Farrell, Center for Strategic Scientific Initiatives, Office of Cancer Nanotechnology Research, National Cancer Institute, 31 Center Drive, Bldg. 31 A, Rm. 10A52, Bethesda, MD 20892 or call non-toll-free number 301-496-5652 or Email your request, including your address to: farrelld@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer Platform Partnership Scientific Progress Reports, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: National Institutes of Health grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. This submission represents a request for OMB to approve new program specific progress report guidelines for Cancer Nanotechnology Platform Partnerships (CNPP) awarded by the National Cancer Institute (NCI). The CNPPs are part of the Alliance for Nanotechnology in Cancer, a network of awards funded by NCI to promote the application of nanotechnology to cancer research and care. The proposed guidelines request information about award performance related to trans-Alliance collaboration, scientific milestones, progress towards clinical translation and technology commercialization, and education and outreach efforts. The report also gathers information on leveraged funding, patents and publications. The information is gathered every six months. This information is needed to monitor the performance of this special program within NCI, funded through Requests for Applications (RFA CA-09-013, released May 29, 2009) using the cooperative agreement mechanism (U01). The information will be used to monitor individual award performance and the effectiveness of the program as a whole. The respondents are the Principal Investigators of the awards, along with their institutional business officials. The awards are administered by and the reports reviewed by the Office of Cancer Nanotechnology Research (OCNR), part of the Center for Strategic Scientific Initiatives within NCI. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 72.
Submission for OMB Review; 30-day Comment Request: Financial Sustainability of Human Tissue Biobanking (NCI)
Document Number: 2013-17642
Type: Notice
Date: 2013-07-23
Agency: Department of Health and Human Services, National Institutes of Health
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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 7, 2013, Vol. 78, p. 26639 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.
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2013-17600
Type: Notice
Date: 2013-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
Food Advisory Committee; Notice of Meeting
Document Number: 2013-17599
Type: Notice
Date: 2013-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification
Document Number: 2013-17554
Type: Notice
Date: 2013-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
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 medical device premarket notification.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards
Document Number: 2013-17550
Type: Notice
Date: 2013-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
Document Number: 2013-17549
Type: Notice
Date: 2013-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
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 requirements for premarket approval of medical devices.
Agency Information Collection Activities: Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
Document Number: 2013-17548
Type: Notice
Date: 2013-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
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 standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.
Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program
Document Number: 2013-17547
Type: Rule
Date: 2013-07-23
Agency: Department of Health and Human Services
HHS is issuing this final rule to clarify how section 340B(e) of the Public Health Service Act (PHSA) will be implemented. The final rule applies section 340B(e) of the PHSA only to drugs transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA). The final rule also sets forth that it is the responsibility of the 340B covered entity to maintain auditable records that demonstrate compliance with the terms of the orphan drug exclusion requirements. This rule will provide clarity in the marketplace, maintain the 340B savings for newly- eligible covered entities, and protect the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act and intended by Congress.
Regulatory Agenda
Document Number: 2013-17060
Type: Unknown
Date: 2013-07-23
Agency: Department of Health and Human Services, Department of Homeland Security, Office of the Secretary
The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.
Semiannual Regulatory Agenda
Document Number: 2013-17059
Type: Unknown
Date: 2013-07-23
Agency: Department of Energy, Department of Health and Human Services
The Department of Energy (DOE) has prepared and is making available its portion of the semiannual Unified Agenda of Federal Regulatory and Deregulatory Actions (Agenda) pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' and the Regulatory Flexibility Act.
Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Correction
Document Number: 2013-17544
Type: Rule
Date: 2013-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical, typographical, and cross- referencing errors in the final rule that appeared in the May 23, 2013 Federal Register titled ``Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs.''
Distribution of Reference Biological Standards and Biological Preparations
Document Number: 2013-17543
Type: Rule
Date: 2013-07-22
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) proposes to update four sections of its regulations titled ``Distribution of Reference Biological Standards and Biological Preparations'' to update the authority citation and reflect the agency's current name, address, and contact information for fees schedules and terms of payment. These updates will not affect current practices.
Compliance Policy Guide Sec. 253.100-Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed; Withdrawal of Compliance Policy Guide
Document Number: 2013-17531
Type: Notice
Date: 2013-07-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of the compliance policy guide (CPG) entitled ``Sec. 253.100Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed,'' issued October 1, 1980, and revised in March 1995.
Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop
Document Number: 2013-17528
Type: Notice
Date: 2013-07-22
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17527
Type: Notice
Date: 2013-07-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17525
Type: Notice
Date: 2013-07-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services