[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17810]


[[Page Unknown]]

[Federal Register: July 22, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0149]

 

Miscellaneous Compliance Policy Guides; Revocation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of eight compliance policy guides (CPG's) because either 
they are outdated, their issues are addressed elsewhere, or they no 
longer reflect current FDA policy. This action is being taken to ensure 
that FDA's CPG's are accurate and reflect FDA policy and sound 
scientific principles.

DATES: Effective July 22, 1994.

FOR FURTHER INFORMATION CONTACT: Judith A. Gushee, Center for 
Veterinary Medicine (HFV-236), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1785.

SUPPLEMENTARY INFORMATION: FDA is revoking eight of its CPG's because 
either they are outdated, their issues are addressed elsewhere, or they 
no longer reflect current FDA policy. The following eight guides are 
being revoked:
    (1) CPG 7125.02 ``Quantity of Contents Declaration on Labels of 
Liquid Animal Feeds''
    CPG 7125.02 was established in 1980 under the Metric Conversion Act 
of 1975 (15 U.S.C. 205b) to clarify FDA's preference for metric 
labeling for liquid animal drugs. The Metric Conversion Act of 1975 was 
amended by the American Technology Preeminence Act of 1991 (ATPA) (Pub. 
L. 102-245). Section 107 of the ATPA amended the Fair Packaging and 
Labeling Act (FPLA) (15 U.S.C. 1451 et seq.) to require that the most 
appropriate metric units be used as the primary system for expressing 
quantity of content. Section 107 of the ATPA was repealed by Pub. L. 
102-329, which provided certain technical amendments to the FPLA, 
including dual (metric and English) labeling and certain exemptions. 
These amendments provide a more appropriate basis for metric labeling. 
Therefore, CPG 7125.02 is unnecessary.
    (2) CPG 7125.04 ``Diethylcarbamazine''
     CPG 7125.04 was established to provide monograph criteria for 
diethylcarbamazine-containing drugs instead of requiring new animal 
drug application (NADA) approval. Since establishing this CPG, FDA has 
determined these products are not exempt from the NADA approval 
process. Therefore, CPG 7125.04 no longer reflects FDA policy.
    (3) CPG 7125.07 ``Impact of CGMPR Violations on NADA''
     The Center for Veterinary Medicine has routinely been involved in 
reviewing results of inspections and district endorsements involving 
NADA's and abbreviated new animal drug applications (ANADA's). For 
those facilities unable to manufacture in compliance with current good 
manufacturing practices (CGMP's), approval of applications was delayed 
pending reinspection and satisfactory corrective action. Compliance 
Program Guidance Manual (CPGM) 7368.001, part V, describes district 
responsibilities in reporting their findings for preapproval 
inspections. The current CPGM is adequate to cover this issue of CGMP 
noncompliance in the preapproval stage. Therefore, CPG 7125.07 is 
superfluous.
    (4) CPG 7125.08 ``Hexachlorophene in Pet Shampoos''
     Pet shampoos are considered grooming aids if they contain 
hexachlorophene at not more than 0.1 percent (as a preservative) and 
are not labeled with therapeutic claims. CPG 7125.21 ``Animal Grooming 
Aids'' and 21 CFR 500.46 adequately address the issues. Therefore, CPG 
7125.08 is not needed.
    (5) CPG 7126.15 ``Crotolaria Seeds in Grains and Feeds''
    At FDA's urging, the feed industry has become meticulous in 
inspecting incoming raw ingredients for foreign materials, including 
crotolaria seeds. Crotolaria, although once a nuisance and a toxin, has 
not been a compliance problem for years. Therefore, CPG 7126.15 is no 
longer relevant.
    (6) CPG 7126.30 ``Diethylstilbestrol Residues in Edible Animal 
Tissue''
     The approval for use of Diethylstilbestrol in animal drugs or 
feeds was withdrawn in the Federal Register of July 6, 1979 (44 FR 
39618 at 39619), as confirmed by the Commissioner's decision in the 
Federal Register of September 21, 1979 (44 FR 54852 at 54900). 
Therefore, CPG 7126.30 is obsolete.
    (7) CPG 7126.32 ``Current Good Manufacturing Practice (CGMP) 
Violations in Medicated Feed Mills--Direct Issuance of Regulatory 
Letters''
     Compliance Program Guidance Manual (CPGM) 7371.004 describes 
current policy concerning warning letters and provides model letters. 
Therefore, CPG 7126.32 is obsolete because it describes regulatory 
letters that are no longer issued.
    (8) CPG 7126.39 ``Ammonium Chloride Used in Ruminant Feeds''
    CPG 7126.39 concerned a formerly approved use of ammonium chloride 
in 21 CFR 558.45 for treating urinary calculi (see the Federal Register 
of March 3, 1986 (51 FR 7382 at 7395)), which has since been withdrawn 
(see the Federal Register of October 26, 1987 (52 FR 39911 at 39912). 
There are no approved drug claims for use of ammonium chloride in 
ruminant feed and the agency has not documented any evidence of misuse 
of the compound in several years. Therefore, CPG 7126.39 is obsolete.

    Dated: July 13, 1994.
 Gary Dykstra,
 Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-17810 Filed 7-21-94; 8:45 am]
BILLING CODE 4160-01-F