Draft Guidance for Industry on Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence; Withdrawal of Guidance, 47217 [05-16019]
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Federal Register / Vol. 70, No. 155 / Friday, August 12, 2005 / Notices
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VerDate jul<14>2003
17:14 Aug 11, 2005
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[FR Doc. 05–15977 Filed 8–11–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D–0835]
Draft Guidance for Industry on
Conjugated Estrogens, USP–LC–MS
Method for Both Qualitative Chemical
Characterization and Documentation of
Qualitative Pharmaceutical
Equivalence; Withdrawal of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Frm 00050
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
David J. Cummings, Center for Drug
Evaluation and Research (HFD–357),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–443–5187.
SUPPLEMENTARY INFORMATION: FDA is
announcing the withdrawal of a draft
guidance for industry entitled
‘‘Conjugated Estrogens, USP–LC–MS
Method for Both Qualitative Chemical
Characterization and Documentation of
Qualitative Pharmaceutical
Equivalence.’’ The agency announced
the availability of the guidance in the
Federal Register of March 9, 2000 (65
FR 12556). The draft guidance was
originally intended to provide
recommendations to applicants on how
to use the liquid chromatography mass
spectrometry (LC–MS) method to
address both qualitative chemical
characterization and qualitative
pharmaceutical equivalence for natural
source conjugated estrogens. FDA is
withdrawing the guidance because
advances in technology allow for the
possibility of using different
methodologies. FDA does not want to
inhibit companies from using a
methodology that might provide
additional scientific data to support
characterization and pharmaceutical
equivalence for conjugated estrogens in
the future. If submitted, these data
would be evaluated to determine
applicability of the method before an
application could be approved.
Dated: August 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16019 Filed 8–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–22049]
Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of a draft guidance for
industry entitled ‘‘Conjugated Estrogens,
USP–LC–MS Method for Both
Qualitative Chemical Characterization
and Documentation of Qualitative
Pharmaceutical Equivalence.’’ FDA is
withdrawing the draft guidance because
the published methodology limits the
submission of scientifically valid
information to the agency that may be
based on different methodologies. FDA
does not want to dictate the scientific
approach for developing adequate
methods.
PO 00000
47217
Collection of Information Under
Review by Office of Management and
Budget (OMB): OMB Control Numbers:
1625–0035 and 1625–0051
Coast Guard, DHS.
Request for comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, the
Coast Guard intends to seek the
approval of OMB for the renewal of two
Information Collection Requests (ICRs).
The ICRs are for 1625–0035, Title 46
CFR Subchapter Q: Lifesaving,
Electrical, and Engineering Equipment,
Construction and Materials & Marine
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 70, Number 155 (Friday, August 12, 2005)]
[Notices]
[Page 47217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16019]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D-0835]
Draft Guidance for Industry on Conjugated Estrogens, USP-LC-MS
Method for Both Qualitative Chemical Characterization and Documentation
of Qualitative Pharmaceutical Equivalence; Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a draft guidance for industry entitled ``Conjugated
Estrogens, USP-LC-MS Method for Both Qualitative Chemical
Characterization and Documentation of Qualitative Pharmaceutical
Equivalence.'' FDA is withdrawing the draft guidance because the
published methodology limits the submission of scientifically valid
information to the agency that may be based on different methodologies.
FDA does not want to dictate the scientific approach for developing
adequate methods.
FOR FURTHER INFORMATION CONTACT: David J. Cummings, Center for Drug
Evaluation and Research (HFD-357), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5187.
SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of a draft
guidance for industry entitled ``Conjugated Estrogens, USP-LC-MS Method
for Both Qualitative Chemical Characterization and Documentation of
Qualitative Pharmaceutical Equivalence.'' The agency announced the
availability of the guidance in the Federal Register of March 9, 2000
(65 FR 12556). The draft guidance was originally intended to provide
recommendations to applicants on how to use the liquid chromatography
mass spectrometry (LC-MS) method to address both qualitative chemical
characterization and qualitative pharmaceutical equivalence for natural
source conjugated estrogens. FDA is withdrawing the guidance because
advances in technology allow for the possibility of using different
methodologies. FDA does not want to inhibit companies from using a
methodology that might provide additional scientific data to support
characterization and pharmaceutical equivalence for conjugated
estrogens in the future. If submitted, these data would be evaluated to
determine applicability of the method before an application could be
approved.
Dated: August 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16019 Filed 8-11-05; 8:45 am]
BILLING CODE 4160-01-S
