TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products. ; ; DATES: This rule is effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/html/2012-10649.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/pdf/2012-10649.pdf ; ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Addendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products. ; ; DATES: This rule is effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/html/2012-10649.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/pdf/2012-10649.pdf ; ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Addendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule; correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 3 May 2012 (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error. ; ; DATES: Effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/html/2012-12594.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/pdf/2012-12594.pdf ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Corrigendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule; correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 3 May 2012 (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error. ; ; DATES: Effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/html/2012-12594.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/pdf/2012-12594.pdf ;
Distribution date: 08 June 2012
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Corrigendum to Regular Notification
Law No. 10465, date 29.09.2011 "On Veterinary Service in the Republic of Albania" .
Distribution date: 05 June 2012
The purposes of this law are: 1. To protect and improve the health of terrestrial and aquatic animals. 2. To establish the procedures for prevention, monitoring, diagnoses, treatment and eradication of animal diseases. 3. To protect public health against zoonotic diseases transmitted from animals as well as from harmful residues in animal products used for human consumption. 4. To ensure implementation of the sanitary-veterinary measures on the products of animal origin, produced at farm level, raw materials, pastures, water and drinking places for animals. 5. To protect the reproduction health of animals and to ensure the increase of production as well as animal breeding. 6. To protect the environment from infections, poisons, animal wastes and pollutions (biological, physical, chemical, radiobiological) with harmful consequences to animal and human health. 7. To establish the procedures of training and information of the veterinarians, animal owners or keepers and the public on veterinary matters. 8. To protect animals against torture and to provide their welfare. 9. To protect wild animals. 10. To ensure safe disposal of dead animals and their carcasses, confiscates, animal wastes and by-products not for human consumption. 11. To establish obligations of farmers, physical and legal persons, in implementation of this law. This law has the following objectives: 1. Establishing of the main principles for the protection of animal health and welfare in compliance with the international standards of the International Animal Health Organization (OIE) and of the European Union; 2. Arranging, organizing, financing of the Veterinary Service, definition of responsibilities, rules and procedures of the Veterinary Service in the protection of animal health and welfare; 3. Protection of the public health in the Republic of Albania from zoonotic diseases transmitable by animals, approximating the EU legislation. This law has the following chapters: Chapter I: General Provisions. Chapter II: Identification and registration of animals and livestock farms. Chapter III: Protection of animal health and control (based on EU Directive 92/119/EC). Chapter IV: Animal Welfare (based on several EU Directives and Regulations such as Council Directive 98/58; Council Directive 86/609; Council Regulation 1099/2009; Council Regulation 1/2005). Chapter V: Disposal of animal products not for human consumption and environment protection. Chapter VI: Monitoring plan of residues and medicated feed (based on EU Directive 96/22 and EU Directive 96/23). Chapter VII: Veterinary Medicinal Products (based on EU Directive 2001/82). Chapter VIII: Organization and performing of veterinary medicine practice. Chapter IX: State veterinary laboratories and veterinary professional education. Chapter X: Organization and competencies of the Veterinary Service. CHAPTER XI: Final dispositions.
Products Covered: Live animals, food products of animal origin, animal by-product, feed, veterinary medicinal products
Regulation Type: Regular notification
Law No. 10465, date 29.09.2011 "On Veterinary Service in the Republic of Albania" .
Distribution date: 05 June 2012
The purposes of this law are: 1. To protect and improve the health of terrestrial and aquatic animals. 2. To establish the procedures for prevention, monitoring, diagnoses, treatment and eradication of animal diseases. 3. To protect public health against zoonotic diseases transmitted from animals as well as from harmful residues in animal products used for human consumption. 4. To ensure implementation of the sanitary-veterinary measures on the products of animal origin, produced at farm level, raw materials, pastures, water and drinking places for animals. 5. To protect the reproduction health of animals and to ensure the increase of production as well as animal breeding. 6. To protect the environment from infections, poisons, animal wastes and pollutions (biological, physical, chemical, radiobiological) with harmful consequences to animal and human health. 7. To establish the procedures of training and information of the veterinarians, animal owners or keepers and the public on veterinary matters. 8. To protect animals against torture and to provide their welfare. 9. To protect wild animals. 10. To ensure safe disposal of dead animals and their carcasses, confiscates, animal wastes and by-products not for human consumption. 11. To establish obligations of farmers, physical and legal persons, in implementation of this law. This law has the following objectives: 1. Establishing of the main principles for the protection of animal health and welfare in compliance with the international standards of the International Animal Health Organization (OIE) and of the European Union; 2. Arranging, organizing, financing of the Veterinary Service, definition of responsibilities, rules and procedures of the Veterinary Service in the protection of animal health and welfare; 3. Protection of the public health in the Republic of Albania from zoonotic diseases transmitable by animals, approximating the EU legislation. This law has the following chapters: Chapter I: General Provisions. Chapter II: Identification and registration of animals and livestock farms. Chapter III: Protection of animal health and control (based on EU Directive 92/119/EC). Chapter IV: Animal Welfare (based on several EU Directives and Regulations such as Council Directive 98/58; Council Directive 86/609; Council Regulation 1099/2009; Council Regulation 1/2005). Chapter V: Disposal of animal products not for human consumption and environment protection. Chapter VI: Monitoring plan of residues and medicated feed (based on EU Directive 96/22 and EU Directive 96/23). Chapter VII: Veterinary Medicinal Products (based on EU Directive 2001/82). Chapter VIII: Organization and performing of veterinary medicine practice. Chapter IX: State veterinary laboratories and veterinary professional education. Chapter X: Organization and competencies of the Veterinary Service. CHAPTER XI: Final dispositions.
Products Covered: Live animals, food products of animal origin, animal by-product, feed, veterinary medicinal products
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 page , available in English)
Distribution date: 30 May 2012 | Final date for Comment: 19 June 2012
The Minimum Requirements for Biological Products shall be partially amended to revise the standard for the Blood Products.
Products Covered: Drugs(HS: 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 page , available in English)
Distribution date: 30 May 2012 | Final date for Comment: 19 June 2012
The Minimum Requirements for Biological Products shall be partially amended to revise the standard for the Blood Products.
Products Covered: Drugs(HS: 30)
Regulation Type: Regular notification
TITLE: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Final rule; delay of compliance dates; request for comments ; ; SUMMARY: The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of 17 June 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; Effective Date: This final rule is effective 18 June 2012. The final rule published at 76 FR 35620 on 17 June 2011, remains effective 18 June 2012. ; ; Comment date: Submit written or electronic comments on the delay of compliance dates by 21 May 2012. ; ; Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on 17 June 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, 3 September 2004, are delayed until 17 December 2013, for products with annual sales of less than $25,000, and until 17 December 2012 for all other products subject to the rule. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/html/2012-11390.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf ;
Distribution date: 23 May 2012
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Final rule; delay of compliance dates; request for comments ; ; SUMMARY: The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of 17 June 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; Effective Date: This final rule is effective 18 June 2012. The final rule published at 76 FR 35620 on 17 June 2011, remains effective 18 June 2012. ; ; Comment date: Submit written or electronic comments on the delay of compliance dates by 21 May 2012. ; ; Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on 17 June 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, 3 September 2004, are delayed until 17 December 2013, for products with annual sales of less than $25,000, and until 17 December 2012 for all other products subject to the rule. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/html/2012-11390.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf ;
Distribution date: 23 May 2012
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
Submit your email ID to receive notifications about upcoming courses and events
