Levothyroxine Sodium Therapeutic Equivalence; Public Meeting, 20574-20575 [05-7883]
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20574
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
when looking up medical devices on the
Internet. It will focus on the ways
individuals find, use, and rate existing
sources of online medical device
information. FDA will use this data to
understand more about its customers
and to make improvements to its own
Web site.
FDA will administer this survey to
individuals who use the Internet to look
for information about medical devices.
The survey will consist of three
components: A screening tool of 5,000
to identify appropriate respondents, an
online survey of 500 customers, and a
telephone followup interview with 50
customers.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Screening tool
5,000
1
5,000
.05
250
Online survey
500
1
500
.25
125
50
1
50
.5
25
Telephone followup
Total
1 There
400
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7882 Filed 4–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0137]
Levothyroxine Sodium Therapeutic
Equivalence; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting on the therapeutic
equivalence of levothyroxine sodium
drug products. This will be a workshop
involving FDA staff and representatives
of three medical societies: The
American Thyroid Association (ATA),
the Endocrine Society, and the
American Association of Clinical
Endocrinologists (AACE). The purpose
of the public meeting is to discuss
FDA’s regulatory standards and
methodological approaches for
determining therapeutic equivalence
between levothyroxine sodium drug
products. The agency is seeking
comments and input from interested
constituencies, including patient
advocacy and education groups, and
pharmaceutical sponsors.
DATES: The public meeting will be held
on May 23, 2005, from 8:30 a.m. to 5
p.m. Submit written or electronic
comments by July 23, 2005.
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
The public meeting will be
held at the National Transportation
Safety Board Boardroom and Conference
Center, 429 L’Enfant Plaza, SW.,
Washington, DC 20594, 202–314–6421.
The center can be reached by Metro
using the L’Enfant Plaza station on the
green, yellow, blue, and orange lines.
For directions, see https://ntsb.gov/
events/newlocation.htm. (FDA has
verified the Web site address, but FDA
is not responsible for any changes to the
Web site after this document publishes
in the Federal Register.)
Submit written comments 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.
ADDRESSES:
Rose
Cunningham, Center for Drug
Evaluation and Research (HFD–006),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20852,
301–443–5595, e-mail:
cunninghamr@cder.fda.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 14,
1997 (62 FR 43535), FDA declared that
oral drug products containing
levothyroxine sodium were considered
new drugs and subject to regulation as
such. The document called for new drug
applications (NDAs) for levothyroxine
sodium products from sponsors wishing
to market such products in the United
States after August 14, 2000. This
deadline was eventually extended to
August 14, 2001.
The NDAs submitted for
levothyroxine sodium products
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
included literature references
supporting the safety and effectiveness
of levothyroxine sodium for the
proposed indications and full
manufacturing information supporting
the purity, potency, and stability of the
products. Manufacturers were required
to target 100 percent of the labeled
levothyroxine sodium content at release.
(Some manufacturers had historically
added a ‘‘stability overage’’ to give their
products a longer shelf-life.) In addition,
bioavailability and in vitro dissolution
studies were required to establish that
the products were readily and
consistently absorbed across the range
of dosage strengths proposed to be
marketed. To assist manufacturers, in
December 2000, FDA published a
guidance on the conduct of in vivo
pharmacokinetic and bioavailability
studies and in vitro dissolution tests on
these products.
FDA has approved seven NDAs for
levothyroxine sodium products. None
were originally rated as interchangeable
with any other. Since their approval,
FDA has approved supplemental NDAs
from some sponsors demonstrating the
therapeutic equivalence
(interchangeability) of their products to
other approved levothyroxine sodium
products. The agency has also approved
one levothyroxine sodium product
under an abbreviated new drug
application (ANDA).
ATA, the Endocrine Society, and
AACE have questioned FDA’s regulatory
and scientific standards for
determination of therapeutic
equivalence of levothyroxine sodium
products, particularly FDA’s
bioequivalence methodology.
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
II. Scope of the Public Meeting
The public meeting is intended to
review FDA’s regulatory and scientific
approach to levothyroxine sodium
products, including manufacturing
standards, in vitro dissolution studies,
and bioavailability/bioequivalence
methods.
The public meeting will also review
clinical, scientific, and methodological
issues relevant to the possible use of
serum thyrotropin concentration as a
pharmacodynamic measure of
levothyroxine sodium bioequivalence.
The public meeting will include
representatives from FDA and from the
three medical societies. A series of brief
presentations will frame the issues
under consideration, followed by panel
discussions involving speakers and
moderators, with questions and
comments from the audience. Other
interested constituencies (e.g., patient
advocacy and education groups,
pharmaceutical sponsors, general
public) will have an opportunity to
provide input during the question and
comment periods.
III. Registration, Agenda, and
Presentations
No registration is required to attend
the meeting. Seating will be on a firstcome, first-served basis. If you need
special accommodations due to a
disability, please contact (see FOR
FURTHER INFORMATION CONTACT).
The agenda for public meeting will be
available on FDA’s Center for Drug
Evaluation and Research Web site at
https://www.fda.gov/cder/meeting/
levothyroxine.htm and at the meeting.
After the meeting, the agenda,
presentations, and transcript will be
placed on file in the Division of Dockets
Management under the docket number
found in the heading of this document
and on CDER’s Web site identified
previously.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the topics discussed in
this document. Submit two copies of
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
V. Transcripts
Copies of the transcript may be
requested in writing from the Freedom
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
of Information Office (HFI–35), Food
and Drug Administration, 5600 Fishers
Lane, rm. 12A–16, Rockville, MD 20857,
approximately 20 working days after the
meeting at a cost of 10 cents per page
or on compact disc at a cost of $14.25
each. You may also examine the
transcript at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 14, 2005.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7883 Filed 4–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0133]
Draft ‘‘Guidance for Industry:
Assessing Donor Suitability and Blood
and Blood Product Safety in Cases of
Known or Suspected West Nile Virus
Infection;’’ Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Assessing
Donor Suitability and Blood and Blood
Product Safety in Cases of Known or
Suspected West Nile Virus Infection,’’
dated April 2005. The draft guidance
document provides revisions to the
previously published recommendations
for assessing donor suitability and
product safety when donors are
diagnosed with or suspected of West
Nile Virus (WNV) infections based on
symptoms and laboratory tests. This
draft guidance proposes revised deferral
periods for such donors, and updates
information on product retrieval and
quarantine. When finalized, this
guidance will supersede ‘‘Guidance for
Industry: Revised Recommendations for
the Assessment of Donor Suitability and
Blood and Blood Product Safety in
Cases of Known or Suspected West Nile
Virus Infection,’’ dated May 2003.
DATES: Submit written or electronic
comments on the draft guidance by May
20, 2005, to ensure their adequate
consideration in preparation of the final
guidance. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
20575
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling the CBER Voice
Information System at 1–800–835–4709
or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit written comments on the draft
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.
FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Assessing Donor Suitability
and Blood and Blood Product Safety in
Cases of Known or Suspected West Nile
Virus Infection,’’ dated April 2005. FDA
developed the information in this draft
guidance after consulting with other
Public Health Service agencies of the
Department of Health and Human
Services.
This draft guidance:
• Applies to donors of blood and
blood components intended for
transfusion;
• Applies to donors of blood
components intended for use in further
manufacturing into injectable products
or noninjectable products, including
recovered plasma, Source Leukocytes,
and Source Plasma;
• Provides updated scientific data;
• Removes the current
recommendation for donor deferral
based upon a reported history of
headache with fever in the week before
donation;
• Proposes new deferral periods for
donors who are diagnosed with or
suspected of WNV infections;
• Describes the use of the
investigational nucleic acid test (NAT)
for WNV in deferring reactive donors;
and
• Provides information about the use
of individual donor NAT testing to reenter reactive donors if a blood
establishment, at its discretion, chooses
to reenter such donors.
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 70, Number 75 (Wednesday, April 20, 2005)]
[Notices]
[Pages 20574-20575]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7883]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0137]
Levothyroxine Sodium Therapeutic Equivalence; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting on the therapeutic equivalence of levothyroxine sodium drug
products. This will be a workshop involving FDA staff and
representatives of three medical societies: The American Thyroid
Association (ATA), the Endocrine Society, and the American Association
of Clinical Endocrinologists (AACE). The purpose of the public meeting
is to discuss FDA's regulatory standards and methodological approaches
for determining therapeutic equivalence between levothyroxine sodium
drug products. The agency is seeking comments and input from interested
constituencies, including patient advocacy and education groups, and
pharmaceutical sponsors.
DATES: The public meeting will be held on May 23, 2005, from 8:30 a.m.
to 5 p.m. Submit written or electronic comments by July 23, 2005.
ADDRESSES: The public meeting will be held at the National
Transportation Safety Board Boardroom and Conference Center, 429
L'Enfant Plaza, SW., Washington, DC 20594, 202-314-6421. The center can
be reached by Metro using the L'Enfant Plaza station on the green,
yellow, blue, and orange lines. For directions, see https://ntsb.gov/
events/newlocation.htm. (FDA has verified the Web site address, but FDA
is not responsible for any changes to the Web site after this document
publishes in the Federal Register.)
Submit written comments 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.
FOR FURTHER INFORMATION CONTACT: Rose Cunningham, Center for Drug
Evaluation and Research (HFD-006), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20852, 301-443-5595, e-mail:
cunninghamr@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 14, 1997 (62 FR 43535), FDA
declared that oral drug products containing levothyroxine sodium were
considered new drugs and subject to regulation as such. The document
called for new drug applications (NDAs) for levothyroxine sodium
products from sponsors wishing to market such products in the United
States after August 14, 2000. This deadline was eventually extended to
August 14, 2001.
The NDAs submitted for levothyroxine sodium products included
literature references supporting the safety and effectiveness of
levothyroxine sodium for the proposed indications and full
manufacturing information supporting the purity, potency, and stability
of the products. Manufacturers were required to target 100 percent of
the labeled levothyroxine sodium content at release. (Some
manufacturers had historically added a ``stability overage'' to give
their products a longer shelf-life.) In addition, bioavailability and
in vitro dissolution studies were required to establish that the
products were readily and consistently absorbed across the range of
dosage strengths proposed to be marketed. To assist manufacturers, in
December 2000, FDA published a guidance on the conduct of in vivo
pharmacokinetic and bioavailability studies and in vitro dissolution
tests on these products.
FDA has approved seven NDAs for levothyroxine sodium products. None
were originally rated as interchangeable with any other. Since their
approval, FDA has approved supplemental NDAs from some sponsors
demonstrating the therapeutic equivalence (interchangeability) of their
products to other approved levothyroxine sodium products. The agency
has also approved one levothyroxine sodium product under an abbreviated
new drug application (ANDA).
ATA, the Endocrine Society, and AACE have questioned FDA's
regulatory and scientific standards for determination of therapeutic
equivalence of levothyroxine sodium products, particularly FDA's
bioequivalence methodology.
[[Page 20575]]
II. Scope of the Public Meeting
The public meeting is intended to review FDA's regulatory and
scientific approach to levothyroxine sodium products, including
manufacturing standards, in vitro dissolution studies, and
bioavailability/bioequivalence methods.
The public meeting will also review clinical, scientific, and
methodological issues relevant to the possible use of serum thyrotropin
concentration as a pharmacodynamic measure of levothyroxine sodium
bioequivalence.
The public meeting will include representatives from FDA and from
the three medical societies. A series of brief presentations will frame
the issues under consideration, followed by panel discussions involving
speakers and moderators, with questions and comments from the audience.
Other interested constituencies (e.g., patient advocacy and education
groups, pharmaceutical sponsors, general public) will have an
opportunity to provide input during the question and comment periods.
III. Registration, Agenda, and Presentations
No registration is required to attend the meeting. Seating will be
on a first-come, first-served basis. If you need special accommodations
due to a disability, please contact (see FOR FURTHER INFORMATION
CONTACT).
The agenda for public meeting will be available on FDA's Center for
Drug Evaluation and Research Web site at https://www.fda.gov/cder/
meeting/levothyroxine.htm and at the meeting. After the meeting, the
agenda, presentations, and transcript will be placed on file in the
Division of Dockets Management under the docket number found in the
heading of this document and on CDER's Web site identified previously.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the topics discussed
in this document. Submit two copies of mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments are available for public examination in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
V. Transcripts
Copies of the transcript may be requested in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 20
working days after the meeting at a cost of 10 cents per page or on
compact disc at a cost of $14.25 each. You may also examine the
transcript at the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: April 14, 2005.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7883 Filed 4-19-05; 8:45 am]
BILLING CODE 4160-01-S
