Compliance Regulations and Guidance Affecting your Industry

This regulation amends the current tolerance for combined residues of pendimethalin and its metabolite, expressed as pendimethalin equivalents, in or on alfalfa forage. BASF Corporation requested this tolerance amendment under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 7, 2010. Objections and requests for hearings must be received on or before June 7, 2010, and must be filed in accordance with the instructions provided in 40 CFR part 178.

EPA is taking final action to approve a request submitted on February 26, 2009, from the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), Air Pollution Control Division, to redesignate the Tennessee portion of the bi-state Memphis, Tennessee-Arkansas 8-hour ozone nonattainment area (hereafter referred to as the ‘‘bi-state Memphis Area’’) to attainment for the 1997 8-hour ozone national ambient air quality standards (NAAQS). The bi-state Memphis 1997 8-hour ozone NAAQS nonattainment area is composed of Shelby County, Tennessee and Crittenden County, Arkansas. EPA’s approval of the redesignation request is based on the determination that the bistate Memphis Area has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA), including the determination that the bi-state Memphis Area has attained the 1997 8- hour ozone standard. Additionally, EPA is approving a revision to the Tennessee State Implementation Plan (SIP) including the 1997 8-hour ozone maintenance plan for Shelby County, Tennessee that contains the new 2006, 2009, 2017, and 2021 motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX ) and volatile organic compounds (VOC) for Shelby County, Tennessee. This action also approves the emissions inventory submitted with the maintenance plan (under the CAA section 182(a)(1)). The State of Arkansas has submitted a similar redesignation request and maintenance plan for the Arkansas portion of this 1997 8-hour ozone area. EPA is taking action on Arkansas’ redesignation request, emissions inventory and maintenance plan through a separate rulemaking action. On March 12, 2008, EPA issued a revised 8-hour ozone standard. EPA later announced on September 16, 2009, that it may reconsider this revised ozone standard. The current action, however, is being taken to address requirements under the 1997 8-hour ozone NAAQS. Requirements for the bi-state Memphis Area under the 2008 standard will be addressed in the future.

Effective Date: This rule will be effective February 3, 2010.

 

We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: The revision 00 of the AIRBUS A330 ALS [Airworthiness Limitations Section] Part 3 was issued primarily to introduce two new CMR [Certification Maintenance Requirements] tasks, referenced 282400–G0001–1–C and 282400– P0001–1–C. ALS Part 3 Revision 01 introduces more restrictive requirements for aircraft configurations already in service. The unsafe condition is safety-significant latent failures that would, in combination with one or more other specific failures or events, result in a hazardous or catastrophic failure condition. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.



 

This guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities.

This guidance is intended to provide information related to certain provisions of the regulations restricting the sale and distribution of cigarettes and smokeless tobacco. See 75 Federal Register 13225 (March 19, 2010). These regulations are effective June 22, 2010.1 More specifically, this guidance provides clarifying information related to FDA’s enforcement policy concerning 21 CFR sections 1140.16(a) and 1140.32(a) of the final rule.

This guidance provides FDA’s current thinking on non-clinical engineering tests that are submitted in investigational device exemption applications (IDEs) and premarket approval applications (PMAs) to support the safety and effectiveness of intravascular stents and their associated delivery systems. This guidance also provides recommendations for labeling for these devices.

The guidance document describes the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor’s mailing address will be changed.

The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA’s regulation on the use of ozonedepleting substances (ODSs) in selfpressurized containers to remove the essential-use designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil as products that do not release ODSs, and therefore they will no longer be essential uses of ODSs as of the effective dates of this rule. MDIs for these active moieties containing an ODS may not be marketed after the relevant effective date.

DATES: Removal of § 2.125(e)(2)(iii) and § 2.125(e)(4)(vii) is effective June 14, 2010. Removal of § 2.125(e)(1)(v) and § 2.125(e)(4)(iv) is effective December 31, 2010. Removal of § 2.125(e)(1)(iii) is effective June 30, 2011. Removal of § 2.125(e)(2)(iv) and § 2.125(e)(4)(viii) is effective December 31, 2013.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor’s mailing address will be changed.

 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor’s mailing address will be changed.

DATES: This rule is effective April 20, 2010.

 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation and restraint of horses.

DATES: This rule is effective April 23, 2010.

 

The Food and Drug Administration (FDA) is amending procedural regulations that pertain to obtaining, submitting, executing, and filing certain documents to reflect new address information for the Center for Devices and Radiological Health (CDRH). All filings and other documents that are subject to these regulations must be directed to the new addresses. This action is being taken to provide accuracy and clarity to the agency’s regulations.

DATES: This regulation is effective April 22, 2010.

 

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.’’ This draft guidance describes the user fees associated with 513(g) requests for information.

DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 28, 2010. Submit written or electronic comments on the collection of information June 28, 2010.

 

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 proposed extension of an existing collection of information pertaining to the submission of tobacco health documents under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).

DATES: Submit written or electronic comments on the collection of information by June 21, 2010.

 

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.

DATES: Fax written comments on the collection of information by June 1, 2010.

 

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.’’ This draft guidance is not final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, FDA is also publishing a notice of availability for a draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.’’

DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on this draft guidance by July 28, 2010. Submit written or electronic comments on the collection of information by June 28, 2010.

 

The Food and Drug Administration (FDA) is announcing that Fonterra (USA) Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of hydrogen peroxide in the manufacture of modified whey by the ultrafiltration method.

The Food and Drug Administration (FDA) has determined the regulatory review period for AFINITOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the issuance of 10 Emergency Use Authorizations (EUAs) (the Authorizations) several of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA also is announcing an amendment to the EUA for the Centers for Disease Control and Prevention (CDC) Swine Influenza Virus Real-time RT-PCR Detection Panel authorized on April 27, 2009. FDA is issuing the Authorizations and amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow. the determination by the Acting Secretary of the U.S. Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has the significant potential to  affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted in this document.

DATES: See the SUPPLEMENTARY INFORMATION section of this document for effective dates of the Authorizations.