[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1161]
[[Page Unknown]]
[Federal Register: January 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Ch. I
[Docket No. 92N-0180]
Withdrawal of Certain Proposed Rules; Final Action
AGENCY: Food and Drug Administration, HHS.
ACTION: Withdrawal of proposed rules.
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SUMMARY: The Food and Drug and Administration (FDA) is announcing that
it is withdrawing 9 of the 10 proposed rules that published in the
notice of intent document that appeared in the Federal Register of
January 19, 1993 (58 FR 4953). The nine proposed rules to be withdrawn
include five proposals that were published before January 1, 1986, and
four other proposed rules which were published on or after January 1,
1986, but which are no longer considered viable candidates for final
action. FDA is taking this action as part of its continuing
comprehensive review of the agency's regulations process.
DATES: The proposed rules are withdrawn January 20, 1994.
FOR FURTHER INFORMATION CONTACT: Edwin V. Dutra, Jr., Office of Policy
(HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-3480.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 28, 1991
(56 FR 42668), FDA announced that it had begun a comprehensive review
of the agency's regulations process, including a review of the backlog
of advance notices of proposed rulemaking, notices of proposed
rulemaking, and other notices for which no final rule or notice of
withdrawal has been issued. The review was begun partly in response to
criticism that the agency's backlog of pending proposals dilutes the
agency's ability to concentrate its attention on higher priority
regulations mandated by statute or necessary to protect public health.
In the Federal Register of December 30, 1991 (56 FR 67440), FDA
published a final action withdrawing 89 proposals.
In the Federal Register of January 19, 1993 (58 FR 4953), FDA
announced its intent to withdraw 10 proposed rules, 5 of which were
published before January 1, 1986, but which were not withdrawn in the
December 30, 1991, document and 5 other proposed rules which were
published on or after January 1, 1986, but which are no longer
considered viable candidates for final action.
FDA received a total of 4 comments regarding the agency's notice
of intent to withdraw the 10 documents (58 FR 4953). Three of the
comments addressed the document on the proposed revocation of xylitol
that published on October 20, 1971 (36 FR 20306). The comments
supported the agency's efforts to withdraw the proposal.
The fourth comment came from a drug manufacturer and disagreed
with FDA's intention to withdraw the proposed amendments to the
dissolution standard for erythromycin capsules that were published in
the Federal Register of October 26, 1989 (54 FR 43592)). The October
1989 document proposed to amend the current dissolution standard from
``85 percent at 45 minutes'' to ``80 percent at 60 minutes'' in 21 CFR
436.542(c) and 452.110c(b)(3). The manufacturer contends that in
comparative studies the results indicated that the two products were
bioequivalent despite the differences in dissolution.
FDA agrees with this comment. The current United States
Pharmacopeia (U.S.P.) dissolution standard requires ``80 percent
dissolution in 60 minutes.'' The October 1989 proposal to revise the
dissolution method from ``85 percent at 45 minutes'' to ``80 percent at
60 minutes'' in 21 CFR 436.542(c) and 452.110c(b)(3) conforms with the
current U.S.P. Data has been reviewed by the agency that would
substantiate the claim that products from both the innovator firm and
another manufacturer are bioequivalent in single as well as multiple
dose studies. After further review of this matter, FDA has concluded
that the current dissolution standard must be revised. Therefore, the
agency is not withdrawing the proposed amendment for erythromycin
capsules that was published on October 26, 1989 (54 FR 43592).
Therefore, for the reasons set forth above, and under the Federal
Food, Drug, and Cosmetic Act and the Public Health Service Act, the
agency announces that it is withdrawing the following nine proposed
rules, published in the Federal Register on the dates indicated:
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Title and brief FR publication date
description Docket No. and cite
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Infection in Chickens; None................ Jan. 1, 1964, 29 FR
Proposed Nomenclature 15
Change; proposal to
modify the poultry
disease term ``chronic
respiratory disease'' to
``complicated chronic
respiratory disease''.
Xylitol; Proposed 89N-0421............ Oct. 20, 1971, 36 FR
Revocation of Food 20306
Additive Regulation;
revocation of unlimited
use of xylitol in special
dietary foods as codified
in 21 CFR 121.1114 (as
recodified in 21 CFR
172.395).
Imminent Hazard Criteria 79N-0305............ Aug. 21, 1979, 44 FR
and Procedure; Proposed 48979
Rule; establishment of
criteria and procedures
for determining whether
approval of certain human
and animal drugs should
be immediately suspended
under the ``imminent
hazard'' provisions of
the act1.
Imminent Hazard 79N-0306............ Aug. 21, 1979, 44 FR
Determinations; 48983
Separation of Functions;
Proposed Rule; rules to
govern the separation of
function in withdrawal
proceedings involving
products for which an
imminent hazard has been
made and revocation of
FDA criteria for making
recommendations to the
Secretary concerning
imminent hazard
determinations.
Export of Investigational 77N-0336............ Nov. 9, 1984, 49 FR
New Animal Drugs; 44766
Tentative Final Rule;
provides for requirements
on notification and
labeling investigational
animal drugs for export1.
Medical Devices; 83N-0190............ Jan. 6, 1986, 51 FR
Invitation for Offers to 564
Submit or to Develop a
Performance Standard for
Vascular Graft Prosthesis
of 6 Millimeters and
Greater Diameter; request
for any existing standard
as a proposed performance
standard for the vascular
graft prosthesis of 6
millimeters and greater
diameter, or to submit an
offer to develop such a
proposed standard or the
agency will proceed to
develop a performance
standard.
Medical Devices; 83N-0192............ Feb. 26, 1986, 51 FR
Invitation for Offers to 6862
Submit or to Develop a
Performance Standard for
Central Nervous system
Fluid Shunt and
Components; request for
any existing standard as
a proposed performance
standard for the central
nervous system fluid
shunt and components, or
to submit an offer to
develop such a proposed
standard or the agency
will proceed to develop a
performance standard.
Medical Devices; 85N-0030............ Apr. 3, 1986, 51 FR
Invitation for Offers to 11516
Submit or Develop a
Performance Standard for
Continuous Ventilator and
Ventilator Tubing;
request for any existing
standard as a proposed
performance standard for
the continuous ventilator
and for ventilator
tubing, or to submit an
offer to develop such a
proposed standard or the
agency will proceed to
develop a performance
standard.
Review of Investigational 86N-0072............ July 25, 1986, 51 FR
Device Exemptions 26830
Regulations; Invitation
to Submit Comments, Data,
and Information; request
for information to assist
FDA in assessing the
benefits, costs, and need
for revision of these
regulations.
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\1\Signed by the Secretary of HHS.
Dated: Janauary 11, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-1161 Filed 1-19-94; 8:45 am]
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