Department of Health and Human Services June 2015 – Federal Register Recent Federal Regulation Documents
Results 301 - 350 of 370
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings With the Office of Orphan Products Development
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792
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.
Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration; Extension of Comment Period
The Food and Drug Administration (FDA or Agency) is extending the comment period in the notice of availability that appeared in the Federal Register of February 19, 2015. In that notice of availability, FDA requested comments on a draft standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration.'' The draft standard MOU describes the responsibilities of any State that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. The Agency is taking this action to allow interested persons additional time to submit comments.
Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intention To Participate
The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Graduate Psychology Education Program
The Health Resources and Services Administration (HRSA) is issuing a limited competition for awards among the 40 current Graduate Psychology Education (GPE) Program grantees whose project periods end June 30, 2016. No more than $1,000,000 will be made available in federal fiscal year (FY) 2015 in the form of 1-year project period grants. These awards are specifically for interprofessional training of doctoral psychology graduate students and interns to address the psychological needs of military personnel, veterans, and their families in civilian and community-based settings, including those in rural areas. An estimated five grants will be awarded with a ceiling amount of $190,000 per grant for 1 year. These funds will be used to establish, expand, and/or enhance activities that were funded under the FY 2013 GPE Program. Program funds are to be used for stipend support for interns and doctoral students, faculty development, curriculum and instructional design, program content enhancement, program infrastructure development, and the supervision and training support of interns.
Proposed Collection; 60-Day Comment Request; Evaluation of the Science Education Partnership Award (SEPA) Program, OD
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 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 to address 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) 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 submit comments in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact Tony Beck, Ph.D., Office of Science Education/SEPA, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Room 206, Bethesda, MD 20892 or call non-toll-free number 301-435-0805 or email your request, including your address to: beckl@mail.nih.gov.
Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of April 21, 2015, for the final rule that appeared in the Federal Register of March 20, 2015, and that amended the color additive regulations to expand the permitted uses of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum.
Veterinary Feed Directive Regulation Questions and Answers; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry (GIF) #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' The purpose of this document is to describe the current Veterinary Feed Directive (VFD) requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a veterinary feed directive drug (VFD feed). This draft revised guidance reflects changes to the VFD requirements under the VFD final rule.
Veterinary Feed Directive
The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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 information collection contained in the guidance for industry on formal dispute resolution.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Generic Drug User Fee Cover Sheet; Form FDA 3794
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 concerning collection of information using Form FDA 3794 entitled ``Generic Drug User Fee Cover Sheet.''
Statement of Organization, Functions, and Delegations of Authority; Administration for Community Living
The Administration for Community Living (ACL) was created in order to achieve several important objectives: to reduce the fragmentation that currently exists in federal programs addressing the community living service and support needs of both the aging and disability populations; to enhance access to quality health care and long-term services and supports for older adults and people with disabilities; to promote consistency in community living policy across other areas of the federal government; and to complement the community infrastructure, as supported by both Medicaid and other federal programs, in order to better respond to the full spectrum of needs of seniors and persons with disabilities. Public Law 113-128, the Workforce Innovation and Opportunity Act (WIOA), furthers these objectives by transferring three groups of programsthe Independent Living (IL) Programs, the National Institute on Disability and Rehabilitation Research (now titled the National Institute on Disability, Independent Living, and Rehabilitation Research), and the Assistive Technology (AT) Act programsfrom the Department of Education's Office of Special Education and Rehabilitative Services (OSERS) to the HHS Administration for Community Living (ACL). This reorganization incorporates these programs into ACL's structure with the IL programs and the AT Act section 5 programs included under the newly established Administration on Disabilities; the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) reporting directly to the ACL Administrator; and the AT Act section 4 programs located in the Office of Consumer Access and Self-Determination within the renamed Center for Integrated Programs (formally the Center for Consumer Access and Self-Determination).
Submission for OMB Review 30-Day Comment Request: DERT Extramural Grantee Data Collection (NIEHS)
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health, 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 March 16, 2015, Volume 80, Number 50, page 13562 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 Environmental Health Sciences (NIEHS), 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: Dr. Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 530 Davis Dr., Room 3055, Morrisville, NC 20560, or call non-toll-free number 919-541-7752 or Email your request, including your address to: pettibonekg@niehs.nih.gov. Formal requests for additional plans and instruments must be requested in writing. PROPOSED COLLECTION DERT Extramural Grantee Data Collection, 0925- 0657, Expiration Date 06/30/2015REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research. Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research. Frequency of Response: Once per grantee, per research portfolio. Affected Public: Current or past grantees from: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute on Deafness and Other Communication Disorders (NIDCD); National Institute of Mental Health (NIMH); National Institute of Neurological Disorders and Stroke (NINDS); National Institute of Environmental Health Sciences (NIEHS); and National Cancer Institute (NCI). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 700.
Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection; Correction
The Food and Drug Administration is correcting a notice entitled ``Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection'' that appeared in the Federal Register of April 29, 2015 (80 FR 23798). The document announced the progress of the Center for Devices and Radiological Health on its 2014-2015 Strategic Priority ``Strike the Right Balance Between Premarket and Postmarket Data Collection.'' The document was published with the incorrect docket number. This document corrects that error.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
The Food and Drug Administration's Education and Outreach Program Targeting School-Aged Children
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Food Safety and Applied Nutrition's (CFSAN) Education and Outreach Program Targeting School-Aged Children (U48). The goal of the Education and Outreach Program Targeting School-Aged Children (U48) is to support educational outreach programs targeting school-aged children which promotes FDA's mission. As part of FDA's mission to promote and protect public health, the educational program's mission is to perform outreach to schoolchildren using FDA-approved food safety and nutrition messages. This proposed cooperative agreement requires the supporting organization to provide teachers for one school year to extend CFSAN's outreach into schools.
Banned Devices; General Provisions; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to clarify that the Agency will provide an opportunity for an informal hearing in connection with a proposed rule to ban a device with a special effective date. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the U.S. Committee for Refugees and Immigrants in Arlington, VA
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to U.S. Committee for Refugees and Immigrants in Arlington, Virginia for a total of $1,060,805. The supplemental funding will ensure that clients' essential needs, such as housing, transportation, communication, food, and medical care, will be met. The supplemental funding will also ensure that USCRI has sufficient staff for the increased number of cases.
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