Compliance Regulations and Guidance Affecting your Industry

 The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ‘‘Substances Prohibited From Use in Animal Food or Feed.’’ In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ‘‘Background’’ section. This document corrects that error.

The Food and Drug  Administration (FDA) is amending its  bottled water regulations to require that  bottled watermanufacturers test source  water for total coliform, as is required  for finished bottled water products, and  to require, if any coliform organisms are  detected in source water, that bottled  water manufacturers determine whether  any of the coliform organisms are  Escherichia coli (E. coli), an indicator of  fecal contamination. FDA also is  amending its bottled water regulations  to require, if any coliform organisms are  detected in finished bottled water  products, that bottled water  manufacturers determine whether any  of the coliform organisms are E. coli.  FDA also is amending the adulteration provision of the bottled water standard  to reflect the possibility of adulteration  caused by the presence of filth. Bottled  water containing E. coli will be  considered adulterated, and source  water containing E. coli will not be  considered to be of a safe, sanitary  quality and will be prohibited from use  in the production of bottled water. FDA  is also amending its bottled water  regulations to require that, before a  bottler can use source water from a  source that has tested positive for E.  coli, the bottler must take appropriate  measures to rectify or eliminate the  cause of E. coli contamination of that  source, and that the bottler must keep  records of such actions. Existing  regulatory provisionsrequire bottled  water manufacturers to keep records of  new testing required by this rule. This  final rule will ensure that FDA’s  standards for the minimum quality of  bottled water, as affected by fecal  contamination, will be no less  protective of the public health than  those set by the Environmental  Protection Agency (EPA) for public  drinking water.

Effective Date: This rule is effective December 1,2009

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Friday, May 29, 2009 (74 FR 25651). The final rule was published with an inadvertent error in the ‘‘Analysis of Impacts’’ section. This document corrects that error

The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency’s regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.

The Food and Drug  Administration (FDA) is announcing the  Establishment of the Tobacco Products  Scientific Advisory Committee. These  actions are needed to implement the  Federal Food, Drug, and Cosmetic Act,  as amended by the Family Smoking  Prevention and Tobacco Control Act.  Elsewhere in this issue of the Federal  Register, FDA is publishing two  separate documents requesting  nominations for voting and non-voting  membership on this committee. This  document also amends the agency’s  regulations to add the Tobacco Products  Scientific Advisory Committee (the  committee) to the agency’s list of  standing advisory committees.

Effective Date: This rule is effective August 26, 2009
 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplemental NADA provides for a revised human food safety warning for use of diclofenac sodium topical cream in horses.

Effective Date: This rule is effective September 16, 2009

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.

Effective Date: This rule is effective September17, 2009.
 

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; AvailabilityThe Food and Drug Administration (FDA) is announcing the  availability of a document entitled  ‘‘Guidance for Industry: Considerations  for Allogeneic Pancreatic Islet Cell  Products’’ dated September 2009. The  guidance document provides  recommendations to manufacturers,  sponsors, and clinical investigators  involved in the transplantation of  allogeneic pancreatic islet cell products  for clinical investigations of the  treatment of type 1 diabetes mellitus.  The guidance identifies the types of data  and information obtained during  investigational new drug studies that  may be helpful in establishing the  safety, purity, and potency of a  biological product in a biologics license  application (BLA). The guidance  announced in this notice finalizes the  draft guidance of the same title, dated  May 2008.


 

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that as of the effective date identified in the FSPTCA, cigarettes that contain certain characterizing flavors are considered adulterated under the act. FDA is also providing in this notice contact information to which individuals who observe violative products after the effective date of the tobacco standard special rule may report their observations to FDA.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for luprostiol injectable solution from Intervet, Inc., to Virbac AH, Inc.

Effective Date:This rule is effective May 27,2009

The Food and Drug Administration (FDA) is amending theanimal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra,Ltd. The NADA provides for the veterinary prescription use of methimazole tablets in cats fortreatment of hyperthyroidism.

Effective Date: This rule is effective June 11,2009

 

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.’’ The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirementthat FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug productsand make those findings publicly available. This guidance describes how FDA will comply with the FDAAA requirement and procedures forapplication holders to update thelabeling of antibacterial drug products and antimicrobial susceptibility testing (AST) devices.
 

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an ApprovedApplication.’’Thisdocumentprovides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-thecounter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA’s Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register .

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.’’ The document provides guidance to the dietary supplement industry for complying with the serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA’s Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Alpharma Inc. The supplemental NADA provides for revised Blue Bird labeling for chlortetracycline Type A medicated articles used to formulate Type B and Type C medicated feeds in various classes of livestock and poultry.

Effective Date:This rule is effective June 12,2009

 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of toceranib phosphate tablets in dogs for treatment of recurrent, cutaneous mast cell tumors .

Effective Date: This rule is effective June 18,2009

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the supplemental approval of a new animal drug application (NADA) filed by Dechra, Ltd. The supplemental NADA provides for the addition of a 10- milligram capsule size of trilostane, used in dogs for treatment of hyperadrenocorticism.

Effective Date: This rule is effective June 26,2009.

The Food and DrugAdministration (FDA) is amending theanimal drug regulations to reflectapproval of an original abbreviated newanimal drug application (ANADA) filedby Cephazone Pharma, LLC. TheANADA provides for the use of ceftiofursodium powder for injection as asolution in dogs, horses, cattle, swine,day old chickens, turkey poults, sheep,and goats as therapy for variousbacterial infections.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of flunixin meglumine injectable solution in swine.

Effective Date: This rule is effective July 15, 2009
 

The Food and Drug  Administration (FDA) is amending the  animal drug regulations to reflect  approval of an original abbreviated new  animal drug application (ANADA) filed  by Norbrook Laboratories, Ltd. The  ANADA provides for the use of flunixin  meglumine injectable solution in swine.