Department of Health and Human Services October 2014 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 282
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-24183
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2014-24182
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-24181
Type: Notice
Date: 2014-10-10
Agency: Department of Health and Human Services
Extension of Deadline; Preschool Development Grants-Development Grants and Preschool Development Grants-Expansion Grants
Document Number: 2014-24265
Type: Notice
Date: 2014-10-09
Agency: Department of Education, Department of Health and Human Services
On August 18, 2014, the Departments of Education and Health and Human Services (Departments) published in the Federal Register (79 FR 48853, 79 FR 48873) notices inviting applications for new awards for fiscal year 2014 for the Preschool Development GrantsDevelopment Grants and Preschool Development GrantsExpansion Grants programs. The notices established October 14, 2014, as the deadline date for eligible applicants to apply for funding under the programs. However, the Departments have been informed that the Grants.gov Web site will be unavailable to applicants on October 11-12, 2014, due to a scheduled maintenance outage. To allow applicants additional time to complete their applications as a result of this outage, we are extending the deadline date for transmittal of applications to October 15, 2014.
Policy on Conferring With Urban Indian Organizations; Correction
Document Number: 2014-24154
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service is issuing this Notice to correct the effective date from October 29, 2014 to September 22, 2014 for the final Policy for Conferring with Urban Indian Organizations. The notice published at 79 FR 58359, September 29, 2014.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL30); Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms; Availability
Document Number: 2014-24152
Type: Notice
Date: 2014-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #143) entitled ``Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms'' (VICH GL30). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The purpose of this VICH guidance document is to describe the controlled lists of terms critical to completing the controlled data fields as identified in the guidance entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine'' (GFI #188), available on the FDA Web site at: http://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.h tm.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-24111
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee
Document Number: 2014-24074
Type: Notice
Date: 2014-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2014-24064
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2014-24063
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2014-24061
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2014-24060
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2014-24059
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2014-24058
Type: Notice
Date: 2014-10-09
Agency: Department of Health and Human Services, National Institutes of Health
Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
Document Number: 2014-24039
Type: Notice
Date: 2014-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-24038
Type: Notice
Date: 2014-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies
Document Number: 2014-23895
Type: Proposed Rule
Date: 2014-10-09
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services
This proposed rule would revise the current conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The proposed requirements would focus on the care delivered to patients by home health agencies, reflect an interdisciplinary view of patient care, allow home health agencies greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
Document Number: 2014-24051
Type: Notice
Date: 2014-10-08
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 ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Proposed Collection; Comment Request; Application Forms for Research Development and Training Grants
Document Number: 2014-24008
Type: Notice
Date: 2014-10-08
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 collections via application forms, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed collections 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) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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 request more information on the proposed programs submit requests to: Jack Stein, Ph.D., Director, Office of Science Policy and Communications, National Institute on Drug Abuse, 6001 Executive Blvd., Room 5185, Rockville, MD 20852, or call non-toll free number 301-443-6071 or email your request, including your address to: jack.stein@nih.gov. Comments Due Date: Comments regarding these programs are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Application Forms for Research Development and Training Grants, 0925-New, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: These programs offer grants and traineeships necessary for growing the biomedical researcher workforce, and the diversity in this workforce. The application forms will collect information of applicants for selecting those that would benefit most effectively from the programs. NIDA is requesting generic approval from OMB for application forms to be used by these programs that will recruit pre-college through post-doctoral underrepresented individuals and individuals of special populations into the research programs of the Institute for research training and research development, for forging mentor/mentee relationships and networking between newly funded underrepresented researchers and experienced investigators funded by NIDA; and for a fellowship program to train new researchers, and support experienced researchers of other nations, in research to advance the science of HIV and drug use while fostering multinational research in this disease area. The application forms will be web-based. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annualized burden hours are 426.
Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2014-24002
Type: Notice
Date: 2014-10-08
Agency: Food and Drug Administration, Department of Health and Human Services
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
Document Number: 2014-24001
Type: Notice
Date: 2014-10-08
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; 30-day Comment Request; a Generic Submission for Theory Development and Validation (NCI)
Document Number: 2014-23999
Type: Notice
Date: 2014-10-08
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 July 14, 2014, Vol. 79, page 40763 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.
Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen; Draft Guidance for Industry; Availability
Document Number: 2014-23973
Type: Notice
Date: 2014-10-08
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 ``Over-the- Counter Pediatric Liquid Drug Products Containing Acetaminophen.'' The draft guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over- the-counter (OTC), acetaminophen-containing pediatric liquid drug products. This guidance provides recommendations for acetaminophen concentration, container labels and carton labeling, packaging of such products, and recommendations regarding any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.
The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2014-23972
Type: Notice
Date: 2014-10-08
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 ``The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.'' FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (DSCSA).
Critical Path Innovation Meetings; Draft Guidance for Industry; Availability
Document Number: 2014-23970
Type: Notice
Date: 2014-10-08
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 ``Critical Path Innovation Meetings.'' This draft guidance describes a Critical Path Innovation Meeting (CPIM), a means by which FDA's Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, government, and patient advocacy groups can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters.
Prescription Drug User Fee Act Patient-Focused Drug Development; Request for Comments
Document Number: 2014-23965
Type: Notice
Date: 2014-10-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining the patient perspective on disease severity and currently available treatments for a set of disease areas. FDA is publishing a preliminary list of nominated disease areas for consideration in patient-focused drug development meetings during fiscal years (FYs) 2016-2017. The public is invited to comment on this preliminary list through a public docket.
Determination That LUPRON DEPOT (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2014-23961
Type: Notice
Date: 2014-10-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for leuprolide acetate for depot suspension, future applicants are advised that they may not be able to obtain LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and the same therapeutic effect.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
Document Number: 2014-23956
Type: Notice
Date: 2014-10-08
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 ``Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Proposed Collection; 60-Day Comment Request; NIMH Data Repositories Data Submission Request; NIMH Data Repositories Data Access and Use Certification
Document Number: 2014-23959
Type: Notice
Date: 2014-10-07
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 Mental Health (NIMH), 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) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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: NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: nimhprapubliccomments@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment 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: NIMH Data Repositories (NDR) Data Submission Request, the NIMH Data Repositories Data Access and Use Certification, 0925-0667 Revision; National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Mental Health (NIMH) Data Repositories are a group of Federal data repositories based on an informatics platform for human-subjects research domains related to mental health, initially established as the National Database for Autism Research (NDAR) to support autism-related research. In 2013, NIMH received approval from OMB for use of the NIMH Data Access Request and Use Certification (DUC) Form to meet the unique data access needs of all existing NIMH data repositories, which at the time consisted of NDAR, Pediatric MRI (PedsMRI), and the NIMH Clinical Research Datasets (NCRD)OMB# 0925-0667 (Expiration: 09/30/2016). Now in 2014, two new databases have been added and integrated into the NDAR infrastructure, NDCT and RDoCdb. At this time, NIMH is seeking OMB approval to add an all-purpose NIMH Data Repositories Data Submission Request Form and to add a revised all-purpose NIMH Data Repositories Data Access and Use Certification Form. As the data repositories have matured, and with the introduction of the new databasesnamely NDCT and RDoCdbthe information being collected for data submission has become more complex, rendering an OMB-approved submission form a new necessity. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 221.
Submission for OMB Review; 30-Day Comment Request; NIMH Database of Cognitive Training and Remediation Studies (DCTRS) (NIMH)
Document Number: 2014-23938
Type: Notice
Date: 2014-10-07
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 April 15, 2014, pages 21250-21252 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 Institute of Mental Health (NIMH), 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.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-23865
Type: Notice
Date: 2014-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-23864
Type: Notice
Date: 2014-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Notice of Charter Renewal
Document Number: 2014-23858
Type: Notice
Date: 2014-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2014-23856
Type: Notice
Date: 2014-10-07
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: 2014-23855
Type: Notice
Date: 2014-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-23854
Type: Notice
Date: 2014-10-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation
Document Number: 2014-23846
Type: Notice
Date: 2014-10-07
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 (PRA).
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval; Guidance for Industry; Availability
Document Number: 2014-23845
Type: Notice
Date: 2014-10-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.'' This guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant (preoperative) setting using pathological complete response (pCR) as a surrogate endpoint that could support approval under the accelerated approval regulations. Despite advances in systemic therapy of early-stage breast cancer over the past few decades, there remains a significant unmet medical need for certain high-risk or poor prognosis populations of early-stage breast cancer patients. This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer. This guidance finalizes the draft guidance issued May 30, 2012.
Laboratory Site Tours Program
Document Number: 2014-23844
Type: Notice
Date: 2014-10-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Tobacco Products' (CTP) Office of Science is announcing an invitation for participation in its Laboratory Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the testing and analysis of tobacco products and tobacco smoke. These visits are intended to provide CTP staff with the opportunity to gain a better understanding of tobacco science and laboratory operations and are not intended as regulatory inspections or facility visits for the purposes of developing Tobacco Product Manufacturing Practice regulations. The purpose of this notice is to invite parties interested in participating in the Laboratory Site Tours Program to submit their requests to CTP.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
Document Number: 2014-23842
Type: Notice
Date: 2014-10-07
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 ``Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2014-23812
Type: Notice
Date: 2014-10-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-23811
Type: Notice
Date: 2014-10-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2014-23810
Type: Notice
Date: 2014-10-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2014-23809
Type: Notice
Date: 2014-10-07
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Availability of the Report on Carcinogens, Thirteenth Edition
Document Number: 2014-23748
Type: Notice
Date: 2014-10-06
Agency: Department of Health and Human Services
The Department of Health and Human Services released the 13th RoC to the public on October 2, 2014. The report is available on the RoC Web site at: http://ntp.niehs.nih.gov/go/roc13 or electronically from the Office of the RoC (see ADDRESSES below).
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-23737
Type: Notice
Date: 2014-10-06
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-23736
Type: Notice
Date: 2014-10-06
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-23735
Type: Notice
Date: 2014-10-06
Agency: Department of Health and Human Services