Energy Policy and New Uses Office, Agriculture Department – Federal Register Recent Federal Regulation Documents

Statement of Organizations, Functions, and Delegations of Authority The Food and Drug Administration (FDA) is announcing that it has reorganized the Office of Foods and Veterinary Medicine (OFVM), Center for Food Safety and Applied Nutrition (CFSAN) by establishing the new Office of Dietary Supplement Programs (ODSP). ODSP will consist of the Evaluation and Research Staff and the Regulatory Implementation Staff. This reorganization resulted in the retitling of the OFVM, CFSAN, Office of Nutrition, Labeling and Dietary Supplements (ONLDS) to the Office of Nutrition and Food Labeling (ONFL), and the abolishment of the Division of Dietary Supplement Programs (DDSP) under ONLDS. This new organizational structure was approved by the Secretary of Health and Human Services on XXXXX and effective upon signature.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance. 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 public comment in response to the notice.

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.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's recordkeeping and registration requirements for shell egg producers.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance on Lamotrigine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lamotrigine extended-release tablets.

The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier Medical Device Conference (MedCon).'' This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications'' and an opportunity for public comment on the topic of drug interactions with hormonal contraceptives (HCs). The goal of this public meeting is to provide an opportunity for FDA to seek input from experts on the public health concerns associated with use of HCs and interacting drugs that might affect efficacy and safety, pharmacokinetic (PK)/pharmacodynamic (PD) considerations in designing drug interaction studies with HCs during drug development, and approaches to translating the results of drug interaction information into informative labeling and communication. The input received may be used to refine FDA's thinking on HC drug interaction study design and interpretation, and labeling communication on drug interaction risk.

The U.S. Department of Health and Human Services (HHS) intends to hold a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition and will convene a public consultation to seek comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonclinical Evaluation of Endocrine-Related Drug Toxicity.'' The purpose of this guidance is to clarify when additional studies are warranted after the standard toxicology tests have been conducted and there is a signal for potential adverse endocrine-related toxicity. This guidance finalizes the draft guidance entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation'' issued on September 20, 2013.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/P Establishments) with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The guidance announced in this notice finalizes the draft guidance of the same title, dated October 2013. The recommendations in the guidance announced in this notice supersedes those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.

The Food and Drug Administration (FDA) has determined that GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1 milligram (mg) base/vial and EQ 10 mg base/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 glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, if all other legal and regulatory requirements are met.

The Administration for Community Living (ACL) announces the intent to award, subject to the availability of funds, single-source grant awards in the amount of $335,000 to the National Association of Area Agencies on Aging (n4a) and $153,500 to the National Association of State United for Aging and Disabilities (NASUAD). The awards will continue supporting and stimulating the ongoing work by these organizations to further develop and assist states and community-based organizations with building their business capacity for managed long- term services and supports and delivery system reform. CFDA Numbers: 93.048