Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability, 61830-61831 [05-21347]
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Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Notices
Reduction Act of 1995 (the PRA) (44
U.S.C. 3501–3520). The collections of
information addressed in the guidance
document have been approved by OMB
in accordance with the PRA under the
regulations governing premarket
notification submissions (21 CFR part
807, subpart E, OMB control number
0910–0120). The labeling provisions
addressed in the guidance have been
approved by OMB under OMB control
number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: October 17, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–21349 Filed 10–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D–0307] (formerly 02D–
0307)
Guidance for Industry on Potassium
Chloride Modified-Release Tablets and
Capsules: In Vivo Bioequivalence and
In Vitro Dissolution Testing;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Potassium Chloride ModifiedRelease Tablets and Capsules: In Vivo
Bioequivalence and In Vitro Dissolution
Testing.’’ This guidance document
provides recommendations to sponsors
of abbreviated new drug applications
(ANDAs) on the design of
bioequivalence studies for modifiedrelease dosage forms of potassium
chloride.
DATES: Submit written or electronic
comments on agency guidances at any
time.
VerDate Aug<31>2005
16:26 Oct 25, 2005
Jkt 208001
Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Lizzie Sanchez, Center for Drug
Evaluation and Research (HFD–650),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–5847.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Potassium Chloride Modified-Release
Tablets and Capsules: In Vivo
Bioequivalence and In Vitro Dissolution
Testing.’’ This guidance is intended to
provide information to sponsors of
ANDAs on the design of bioequivalence
studies for modified-release dosage
forms of potassium chloride.
A document entitled ‘‘Guidance for In
Vivo Bioequivalence Study for SlowRelease Potassium Chloride Tablets/
Capsules’’ was issued on May 15, 1987
(1987 guidance), and revised on June 6,
1994 (1994 revision). The guidance was
further revised to incorporate FDA’s
current thinking on the bioequivalence
requirements for potassium chloride
modified-release products and was
issued in draft on August 7, 2002 (2002
draft guidance) (67 FR 51284).
Comments were reviewed and
incorporated. The most substantive
changes made are described in the
following paragraphs. Editorial changes
were also made and the final guidance
is now available.
In the 2002 draft guidance, the agency
recommended a three-way crossover
design study comparing the reference
listed drug (RLD) to both the generic
product and a solution of potassium
chloride. The 2002 draft guidance also
recommended analysis of covariance
(ANCOVA) for the pharmacokinetic
parameters.
The final guidance provides
recommendations for a two-way
crossover design comparing the generic
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
product to the RLD. This design is
consistent with the 1994 revision,
which stated that the potassium
chloride solution mentioned in the 1987
guidance was no longer necessary and
recommended the use of a twotreatment, two-period, single-dose,
fasting study comparing test product
with reference product. The FDA
determined that the potassium chloride
solution arm is not necessary because
the objective of the bioequivalence
study is to directly compare the rate and
extent of potassium absorption from the
test product and the reference product.
Therefore, the potassium chloride
solution arm is not necessary for the
test-versus-reference comparison and
adds unnecessary complexity to the
statistical bioequivalance analysis.
We also have decided not to
recommend the use of ANCOVA in the
final guidance. Analysis of variance
(ANOVA) with baseline correction is
adequate for bioequivalence analysis of
pharmacokinetic data obtained
following oral administration of
potassium chloride drug products. The
FDA concluded that using ANCOVA
with baseline as a covariate to analyze
baseline-uncorrected data was not as
sensitive to changes in formulation
performance as using ANOVA to
analyze baseline-corrected data.
The dissolution testing and criteria for
waivers on in vivo testing for lower
strengths are revised to reflect the
changes outlined in the guidance
entitled ‘‘Bioavailability and
Bioequivalence Studies for Orally
Administered Drug Products—General
Considerations,’’ available on the
Internet at https://www.fda.gov/cder/
guidance/index.htm.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on studies to
demonstrate the bioequivalence of
potassium chloride modified-release
tablets and capsules. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
E:\FR\FM\26OCN1.SGM
26OCN1
Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Notices
docket number found in brackets in the
heading of this document. The guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: October 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21347 Filed 10–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
[Docket No. TSA–2005–21866]
Extension Agency Information
Collection Activity Under OMB Review:
Enhanced Security Procedures at
Ronald Reagan National Airport (DCA)
Transportation Security
Administration (TSA), DHS.
ACTION: Notice.
AGENCY:
This notice announces that
TSA has forwarded the Information
Collection Request (ICR) abstracted
below to the Office of Management and
Budget (OMB) for review and approval
of an extension of the currently
approved collection under the
Paperwork Reduction Act. The ICR
describes the nature of the information
collection and its expected burden. TSA
published a Federal Register notice,
with a 60-day comment period soliciting
comments, of the following collection of
information on August 26, 2005, 70 FR
50391.
DATES: Send your comments by
November 25, 2005. A comment to OMB
is most effective if OMB receives it
within 30 days of publication.
ADDRESSES: Comments may be faxed to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: DHS–TSA Desk
Officer, at (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Katrina Wawer, Information Collection
Specialist, Office of Transportation
Security Policy, TSA–9, Transportation
Security Administration, 601 South
12th Street, Arlington, VA 22202–4220.
SUPPLEMENTARY INFORMATION:
SUMMARY:
VerDate Aug<31>2005
16:26 Oct 25, 2005
Jkt 208001
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995, (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information,
unless it displays a valid OMB control
number. Therefore, in preparation for
OMB review and approval of the
following information collection, TSA is
soliciting comments to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Information Collection Requirement
Title: Enhanced Security Procedures
at Ronald Reagan National Airport
(DCA).
Type of Request: Extension of a
currently approved collection.
OMB Control Number: 1652–0035.
Forms(s): ‘‘Flight Authorization
Request Form,’’ ‘‘Armed Security
Officer Nomination Form,’’ ‘‘FBO and
Operator Initial Information Survey.’’
Affected Public: General aviation
aircraft operators, crewmembers, and
passengers.
Abstract: On July 19, 2005, TSA
published an interim final rule (IFR) to
restore access to Ronald Reagan
National Airport (DCA) for certain
aircraft operations while maintaining
the security of critical Federal
Government and other assets in the
Washington, DC metropolitan area. The
IFR amended 49 CFR part 1562 by
adding a new subpart B entitled Ronald
Reagan-Washington National Airport:
Enhanced Security Procedures for
Certain Operations. The IFR and this
information collection apply to all
passenger aircraft operations into or out
of DCA, except U.S. air carrier
operations operating under a full
security program required by 49 CFR
part 1544 and foreign air carrier
operations operating under 49 CFR
1546.101(a) or (b). TSA requires
individuals designated as security
coordinators by Fixed Based Operators
(FBOs) and general aviation aircraft,
flight crewmembers who operate general
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
61831
aviation aircraft into and out of DCA in
accordance with the IFR, and armed
security officers (ASOs) approved in
accordance with the IFR to submit
fingerprints and other identifying
information. In addition, general
aviation aircraft operators are required
to provide TSA with identifying
information for all individuals onboard
each aircraft that operates into and out
of DCA. General aviation aircraft
operators also are required to provide
TSA with the flight plan and
registration number of their aircraft that
will operate to or from DCA. Finally,
aircraft operators and FBOs are required
to nominate the individuals they would
like to be qualified as ASOs by
submitting an ASO Nomination Form to
TSA. Once nominated, the ASOs are
required to submit identifying
information, as well as employment
history information, by completing an
on-line application.
Number of Respondents: 2,025.
Estimated Annual Burden Hours: An
estimated 13,298 hours annually.
Issued in Arlington, Virginia, on October
19, 2005.
Lisa S. Dean,
Privacy Officer.
[FR Doc. 05–21364 Filed 10–25–05; 8:45 am]
BILLING CODE 4910–62–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[CIS No. 2352–05]
RIN 1615–ZA23
Adjustment of the Immigration Benefit
Application Fee Schedule; Correction
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: Notice of correction.
AGENCY:
SUMMARY: U.S. Citizenship and
Immigration Services (USCIS) published
a notice in the Federal Register on
September 26, 2005 at 70 FR 56182 to
increase the fees for immigration benefit
applications and petitions to account for
cost increases due to inflation. In the fee
table of the September 26, 2005 notice,
USCIS added a footnote ‘‘6’’ next to the
new fee for the Form N–600K. Footnote
‘‘6’’ shows an increase in fee from $200
to $215 for an application filed on
behalf of an adopted child (as compared
to the base fee increase from $240 to
$255). The placement of this footnote
and its lack of specificity regarding
which ‘‘application’’ it was meant to
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 70, Number 206 (Wednesday, October 26, 2005)]
[Notices]
[Pages 61830-61831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21347]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0307] (formerly 02D-0307)
Guidance for Industry on Potassium Chloride Modified-Release
Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution
Testing; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Potassium Chloride
Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In
Vitro Dissolution Testing.'' This guidance document provides
recommendations to sponsors of abbreviated new drug applications
(ANDAs) on the design of bioequivalence studies for modified-release
dosage forms of potassium chloride.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lizzie Sanchez, Center for Drug
Evaluation and Research (HFD-650), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5847.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Potassium Chloride Modified-Release Tablets and Capsules: In
Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance
is intended to provide information to sponsors of ANDAs on the design
of bioequivalence studies for modified-release dosage forms of
potassium chloride.
A document entitled ``Guidance for In Vivo Bioequivalence Study for
Slow-Release Potassium Chloride Tablets/Capsules'' was issued on May
15, 1987 (1987 guidance), and revised on June 6, 1994 (1994 revision).
The guidance was further revised to incorporate FDA's current thinking
on the bioequivalence requirements for potassium chloride modified-
release products and was issued in draft on August 7, 2002 (2002 draft
guidance) (67 FR 51284). Comments were reviewed and incorporated. The
most substantive changes made are described in the following
paragraphs. Editorial changes were also made and the final guidance is
now available.
In the 2002 draft guidance, the agency recommended a three-way
crossover design study comparing the reference listed drug (RLD) to
both the generic product and a solution of potassium chloride. The 2002
draft guidance also recommended analysis of covariance (ANCOVA) for the
pharmacokinetic parameters.
The final guidance provides recommendations for a two-way crossover
design comparing the generic product to the RLD. This design is
consistent with the 1994 revision, which stated that the potassium
chloride solution mentioned in the 1987 guidance was no longer
necessary and recommended the use of a two-treatment, two-period,
single-dose, fasting study comparing test product with reference
product. The FDA determined that the potassium chloride solution arm is
not necessary because the objective of the bioequivalence study is to
directly compare the rate and extent of potassium absorption from the
test product and the reference product. Therefore, the potassium
chloride solution arm is not necessary for the test-versus-reference
comparison and adds unnecessary complexity to the statistical
bioequivalance analysis.
We also have decided not to recommend the use of ANCOVA in the
final guidance. Analysis of variance (ANOVA) with baseline correction
is adequate for bioequivalence analysis of pharmacokinetic data
obtained following oral administration of potassium chloride drug
products. The FDA concluded that using ANCOVA with baseline as a
covariate to analyze baseline-uncorrected data was not as sensitive to
changes in formulation performance as using ANOVA to analyze baseline-
corrected data.
The dissolution testing and criteria for waivers on in vivo testing
for lower strengths are revised to reflect the changes outlined in the
guidance entitled ``Bioavailability and Bioequivalence Studies for
Orally Administered Drug Products--General Considerations,'' available
on the Internet at https://www.fda.gov/cder/guidance/index.htm.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on studies to demonstrate the bioequivalence
of potassium chloride modified-release tablets and capsules. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Submit a single copy of electronic comments or two paper copies
of any mailed comments, except that individuals may submit one paper
copy. Comments are to be identified with the
[[Page 61831]]
docket number found in brackets in the heading of this document. The
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: October 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21347 Filed 10-25-05; 8:45 am]
BILLING CODE 4160-01-S
