Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 25833-25834 [05-9672]
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Federal Register / Vol. 70, No. 93 / Monday, May 16, 2005 / Notices
I. Withdrawal of Approval of NDA 50–
744
CollaGenex Pharmaceutical, Inc.
(CollaGenex), is the holder of NDA 50–
744 for PERIOSTAT (doxycycline
hyclate) 20-mg capsules. In a letter
dated September 24, 2001, CollaGenex
informed FDA that this drug product is
no longer marketed and said it ‘‘is
hereby withdrawing NDA 50–744.’’ In a
citizen petition dated July 10, 2002
(Docket No. 2002P–0312/CP1),
CollaGenex requested that FDA
withdraw approval of the application.
The applicant has, by its request,
waived its opportunity for a hearing.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(e)) and under
authority delegated to the Director,
Center for Drug Evaluation and
Research, approval of NDA 50–744 and
all amendments and supplements
thereto, is hereby withdrawn.
II. Determination That Doxycycline
Hyclate 20-Mg Capsules Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
In 1984, Congress enacted the Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is a version of the drug that was
previously approved under a new drug
application. Sponsors of ANDAs do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of an NDA. The only clinical
data required in an ANDA are data to
show that the drug that is the subject of
the ANDA is bioequivalent to the listed
drug.
The 1984 amendments include what
is now section 505(j)(7) of the act (21
U.S.C. 355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)),
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16:37 May 13, 2005
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the agency may make a determination as
to whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness at any time if the drug has
been voluntarily withdrawn from sale.
In its July 10, 2002, citizen petition,
CollaGenex requested that FDA refuse to
approve any ANDA for a generic version
of doxycycline hyclate 20-mg capsules
until FDA determines that PERIOSTAT
(doxycycline hyclate) 20-mg capsules
were not withdrawn for reasons of
safety or effectiveness. CollaGenex also
requested that PERIOSTAT
(doxycycline hyclate) 20-mg capsules be
moved to the ‘‘Discontinued Drug
Product List’’ of the Orange Book and
that FDA publish a notice in the Federal
Register withdrawing approval of
PERIOSTAT (doxycycline hyclate) 20mg capsules. CollaGenex noted in its
petition that it now has an approved
NDA for a tablet version of PERIOSTAT.
On July 10, 2002, CollaGenex also filed
a petition for stay of action (Docket No.
2002P–0312/PSA1) requesting that FDA
stay approval or receipt of any ANDA
for a generic version of PERIOSTAT
capsules pending final resolution of the
issues in CollaGenex’s citizen petition.
In a citizen petition dated August 13,
2002 (Docket No. 2002P–0367/CP1),
submitted under 21 CFR 10.25(a), 10.30,
314.122, and 314.161, West-ward
Pharmaceutical Corp., requested that
FDA determine whether PERIOSTAT
(doxycycline hyclate) 20-mg capsules
were withdrawn from sale for reasons of
safety or effectiveness. This Federal
Register notice resolves all such issues
in the citizen petitions referenced in
this document.
FDA has reviewed its records and,
under § 314.161, has determined that
PERIOSTAT (doxycycline hyclate) 20mg capsules were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the agency
will list doxycycline hyclate 20-mg
capsules in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs for
doxycycline hyclate 20-mg capsules
may be approved by the agency.
Dated: May 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9624 Filed 5–13–05; 8:45 am]
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25833
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of the Committee: Obstetrics and
Gynecology Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on June 23, 2005, from 9 a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone
Rooms, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact: Michael Bailey, Center for Devices
and Radiological Health (HFZ–470), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301–594–1180
or FDA Advisory Committee Information
Hotline, 1–800–741–8138 (301–443–0572 in
the Washington, DC area), code 3014512524.
Please call the Information Line for up-todate information on this meeting.
Agenda: The committee will hear a
presentation on the FDA Critical Path
Initiative. The committee will also discuss,
make recommendations, and vote on a
premarket approval application for a fetal
heart monitoring device that, in addition to
standard features, is used during labor and
delivery to measure, display, and analyze the
ST waveform of the fetal electrocardiogram.
Background information, including the
agenda and questions for the committee, will
be available to the public 1 business day
before the meeting on the Internet at http:/
/www.fda.gov/cdrh/panelmtg.html.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person by June 16, 2005.
Oral presentations from the public will be
scheduled between approximately 9:30 a.m.
and 10 a.m. and between approximately 3:30
p.m. and 4 p.m. Time allotted for each
presentation may be limited. Those desiring
to make formal presentations should notify
the contact person before June 16, 2005, and
submit a brief statement of the general nature
of the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an indication of
the approximate time requested to make their
presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
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25834
Federal Register / Vol. 70, No. 93 / Monday, May 16, 2005 / Notices
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact AnnMarie
Williams, Conference Management Staff, at
240–276–0450, ext. 113, at least 7 days in
advance of the meeting.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app.2).
Dated: May 9, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–9672 Filed 5–13–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with the requirement
for the opportunity for public comment
on proposed data collection projects
(section 3506 (c) (2) (A) of Title 44,
United States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer at (301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the Agency,
including whether the information shall
have practical utility; (b) the accuracy of
the Agency’s estimate of the burden of
the proposed collection of information;
(c) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Number of
respondents
Type of form
Application/Annual Report ...............................................................................
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 day of this notice.
Dated: May 10, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–9675 Filed 5–13–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with the requirement
for the opportunity for public comment
on proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995 (Pub.
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Fmt 4703
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The Health Resources and Services
Administration (HRSA) proposes to
continue utilization of current reporting
requirements for SPRANS projects, CISS
projects, and other grant programs
administered by the Maternal and Child
Health Bureau (MCHB), that include
national performance measures
developed in accordance with
requirements of the ‘‘Government
Performance and Results Act (GPRA) of
1993’’ [Pub. L. 103–62]. The MCHB
developed and had approved by OMB a
set of performance measures for its
discretionary funding programs in 2003.
No major changes have been made to
the performance measures, only minor
editorial or format changes have been
made for clarification. The burden
estimate for this activity is based upon
information provided by current and
past MCHB discretionary funds
supported projects, as well as
experience in completing the current
forms. The reporting burden is as
follows:
Responses
per
respondent
750
L. 104–13)), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed grant
information collection activity or to
obtain a copy of the data collection plan
and draft instruments, call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for proper performance of
grantee functions including whether the
information will have practical utility;
(b) the accuracy of the burden estimate
of the proposed collection of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the information
collection burden on respondents,
including the use of automated
collection methods or other types of
information technology.
PO 00000
Proposed Project: Maternal and Child
Health Bureau (MCHB) Common Grant
Guidance for Discretionary Grants
(OMB No. 0915–0272)—Revision
Burden hours
per response
1
6
Total burden
hours
4,500
Proposed Project: Ryan White
Comprehensive AIDS Resources
Emergency (CARE) Act Title II Grant
Application Information Supplements:
NEW
The CARE Act (codified under Title
XXVI of the Public Health Service Act)
was first enacted by Congress in 1990,
and reauthorized in 1996 and 2000. It
addresses the unmet health needs of
persons living with HIV disease by
funding primary health care and
support services that enhance access to
and retention in care. The CARE Act
funded services reach over 571,000
individuals; after Medicaid and
Medicare, it is the largest single source
of Federal funding for HIV/AIDS care
for low-income, uninsured, and
underinsured Americans. The Title II
Care Grant Program (CGP) provides
formula grants to all 50 States; the
District of Columbia; the
Commonwealth of Puerto Rico; the
Territories of the Virgin Islands, Guam,
and American Samoa; the
Commonwealth of the Northern Mariana
Islands, the Republic of Palau, the
Federated States of Micronesia, and the
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[Federal Register Volume 70, Number 93 (Monday, May 16, 2005)]
[Notices]
[Pages 25833-25834]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9672]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of the Committee: Obstetrics and Gynecology Devices Panel
of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on June 23, 2005, from 9
a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact: Michael Bailey, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1180 or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington,
DC area), code 3014512524. Please call the Information Line for up-
to-date information on this meeting.
Agenda: The committee will hear a presentation on the FDA
Critical Path Initiative. The committee will also discuss, make
recommendations, and vote on a premarket approval application for a
fetal heart monitoring device that, in addition to standard
features, is used during labor and delivery to measure, display, and
analyze the ST waveform of the fetal electrocardiogram. Background
information, including the agenda and questions for the committee,
will be available to the public 1 business day before the meeting on
the Internet at https://www.fda.gov/cdrh/panelmtg.html.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by June 16,
2005. Oral presentations from the public will be scheduled between
approximately 9:30 a.m. and 10 a.m. and between approximately 3:30
p.m. and 4 p.m. Time allotted for each presentation may be limited.
Those desiring to make formal presentations should notify the
contact person before June 16, 2005, and submit a brief statement of
the general nature of the evidence or arguments they wish to
present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to
electrical outlets.
[[Page 25834]]
FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie
Williams, Conference Management Staff, at 240-276-0450, ext. 113, at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app.2).
Dated: May 9, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9672 Filed 5-13-05; 8:45 am]
BILLING CODE 4160-01-S
