[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