Department of Health and Human Services June 3, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
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.
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