June 16, 2014 – Federal Register Recent Federal Regulation Documents

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on communication studies involving FDA- regulated products intended for use in animals. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health.

These special conditions are issued for the Bombardier Aerospace Models BD-500-1A10 and BD-500-1A11 airplanes. These airplanes have novel or unusual design features as compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features include engine size and the potential torque loads imposed by sudden engine stoppage. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Office of National Drug Control Policy (ONDCP) will host a ``Summit on Heroin and Prescription Drugs: Federal, State, and Community Responses'' highlighting the public health and safety issues surrounding prescription painkillers and heroin. The conference will be held from 9 a.m. to 12:30 p.m. on Thursday, June 19, 2014 in the South Court Auditorium of the Eisenhower Executive Office Building, 17th Street and Pennsylvania Avenue NW., Washington, DC 20500. While the summit is not open to the general public, it will be streamed live on- line for the general public to view on www.WhiteHouse.gov/Live. The goal of the summit is to discuss trends and challenges in the epidemic of opioid abuse in the United States, identify innovative practices and models, and discuss how practitioners at every level can help reduce overdose deaths and public health consequences. Participants will include Attorney General Eric Holder, Vermont Governor Peter Shumlin, National Institute on Drug Abuse Director Dr. Nora Volkow, and experts from across the country on education, treatment, and overdose and infectious disease prevention. Summit participants will not be deliberating or providing consensus advice or recommendations to ONDCP. Issues explored will include expanding drug treatment access to millions through the Affordable Care Act, encouraging people and medical professionals to learn the signs and symptoms of problematic drug use and to intervene before substance use becomes a chronic condition, and supporting the use of naloxone, an overdose reversal drug that's easy to administer and has already saved thousands of lives.

The Office of the Inspector General proposes to alter a system of records, CIG-04, Case Reporting and Information Management System Records, in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system of records contains open and closed case listings, statistical reports, and records to support the investigative process such as suitability, loyalty, eligibility, and general trustworthiness of individuals for access or continued access to classified information and suitability for access to government facilities.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

The Food and Drug Administration (FDA) has determined that LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 milligrams (mg)/1 milliliter (mL), 10 mL total fill volume, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, if all other legal and regulatory requirements are met.

This document sets forth the revised appendices to the Dairy Tariff-Rate Import Quota Licensing Regulation for the 2014 quota year reflecting the cumulative annual transfers from Appendix 1 to Appendix 2 for certain dairy product import licenses permanently surrendered by licensees or revoked by the Licensing Authority.

The Department of the Army proposes to amend a system of records, A0165-1a DACH, entitled ``Baptism, Marriage, and Funeral Files'' in its inventory of record systems subject to the Privacy Act of 1974, as amended. This is now a closed system; no new records may be added. The system was used to render service to military members, their dependents and authorized civilians.

The Environmental Protection Agency (EPA) is proposing to approve a revision to the Great Basin Unified Air Pollution Control District (GBUAPCD) portion of the California State Implementation Plan (SIP). This revision concerns particulate matter (PM) emissions from agriculture. We are proposing to approve a local rule to regulate this emission source under the Clean Air Act (CAA or the Act).

The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).