[Federal Register Volume 60, Number 217 (Thursday, November 9, 1995)]
[Notices]
[Pages 56608-56609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27802]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88N-0394]


Generic Animal Drug and Patent Term Restoration Act; Ninth Policy 
Letter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a ninth policy letter, dated June 27, 1995, concerning 
implementation of the Generic Animal Drug and Patent Term Restoration 
Act (GADPTRA). The ninth policy letter states the revised policy of the 
Center for Veterinary Medicine (CVM) on the environmental information 
to be submitted by sponsors for generic animal drug products. The 
agency is soliciting comments on the policy letter.

DATES: Written comments may be submitted at any time regarding this or 
previous policy letters or implementation of GADPTRA in general.

ADDRESSES: Submit written requests for single copies of the ninth 
policy letter to the Industry Information Staff (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Send two self-addressed adhesive labels to assist 
that office in processing your request. Submit written comments on the 
ninth policy letter to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 
20857. Requests and comments should be identified with the docket 
number found in brackets in the heading of this document. The ninth 
policy letter and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Charles E. Eirkson, Center for 
Veterinary Medicine (HFV-152), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1683.
 SUPPLEMENTARY INFORMATION: On November 16, 1988, President Reagan 
signed GADPTRA into law (Pub. L. 100-670). GADPTRA amends the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) by extending the 
generic approval system to copies of new animal drugs that were 
approved after October 10, 1962, and provides patent extension for 
certain animal drugs.
    FDA has published notices of availability for eight policy letters 
concerning implementation of GADPTRA. A list of the publication dates 
and topics of the first five letters was published in the Federal 
Register of June 18, 1990 (55 FR 24645). In the Federal Register of 
October 31, 1990 (55 FR 45860), FDA published a notice of availability 
of the sixth letter dated October 17, 1990. In the Federal Register of 
April 15, 1991 (56 FR 15083), FDA published a notice of availability of 
the seventh policy letter dated March 20, 1991. In the Federal Register 
of August 21, 1991 (56 FR 41561), FDA published a notice of 
availability of the eighth policy letter dated July 23, 1991.
    FDA is now announcing the availability of a ninth policy letter 
dated June 27, 1995, which is a revision of the second policy letter, 
dated June 7, 1989. The second letter notified sponsors to submit an 
environmental assessment (EA) that addresses the environmental impact 
associated with the manufacture of the generic bulk drug and finished 
product. Based on the experience acquired from reviewing a considerable 
number of these EA's with no significant environmental impact 
identified, CVM has confirmed that there is no reason to believe the 
manufacture of generic animal drugs may significantly affect the 
environment and decided, in most cases, CVM will categorically exclude 
generic animal drug applications from preparation of an EA under 21 CFR 
25.24(d)(1).
    This policy does not create or confer any rights, privileges, or 
benefits for or on any person, nor does it operate to bind FDA in any 
way. The agency anticipates that changes in these policy statements may 
occur in the future. When and if changes are made, copies of the 
revised policy statements will be placed on display in the Dockets 
Management Branch (address above) and a notice of availability will be 
published in the Federal Register.
    In addition, the subjects contained in these policy statements may 
be addressed in the regulations that will implement GADPTRA. Comments 
submitted in response to this notice will be considered in the drafting 
of the proposed regulations.

    Dated: November 3, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-27801 Filed 11-8-95; 8:45 am]
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[[Page 56609]]

[Docket No. 95N-0356]


Schering Corp., et al.; Withdrawal of Approval of Seven 
Abbreviated Antibiotic Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of seven abbreviated antibiotic applications (AADA's). The holders of 
the AADA's notified the agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

EFFECTIVE DATE: November 9, 1995.

FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.

SUPPLEMENTARY INFORMATION: The holders of the AADA's listed in the 
table in this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications. The applicants have also, by their request, waived their 
opportunity for a hearing.

                                                                        
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  AADA No.               Drug-                        Applicant         
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61-979       Sisomicin Sulfate USP........  Schering Corp., 2000        
                                             Galloping Hill Rd.,        
                                             Kenilworth, NJ 07033.      
62-119       Doxycycline Hyclate Capsules,  Halsey Drug Co., Inc., 1827 
              50 milligrams (mg) and 100     Pacific St., Brooklyn, NY  
              mg.                            11233.                     
62-267       Gentamicin Sulfate USP.......  Chinoin Pharmaceutical and  
                                             Chemical Works Co. Ltd., c/
                                             o Forum Products, Inc., 33 
                                             Flying Point Rd.,          
                                             Southampton, NY 11968.     
62-403       Nystatin USP.................  Do.                         
62-406       Sterile Chloramphenicol        Elkins-Sinn Pharmaceuticals,
              Sodium Succinate USP.          Two Esterbrook Lane, Cherry
                                             Hill, NJ 08003-4099.       
62-534       Gentamicin Sulfate Ointment    Pharmaderm, 60 Baylis Rd.,  
              USP.                           Melville, NY 11747.        
62-618       Erythromycin Delayed-Release   Parke-Davis, 2800 Plymouth  
              Capsules USP.                  Rd., Ann Arbor, MI 48105.  
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    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research (21 CFR 5.82), 
approval of the AADA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective November 9, 1995.

    Dated: October 30, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-27802 Filed 11-8-95; 8:45 am]
BILLING CODE 4160-01-F