Update on Leukocyte Reduction of Blood and Blood Components; Public Workshop, 35684-35685 [05-12185]
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35684
Federal Register / Vol. 70, No. 118 / Tuesday, June 21, 2005 / Notices
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 Federal
Food, Drug, and Cosmetic Act (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
in part 314 (21 CFR part 314), 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withdrawn from the list if the agency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withdrawn from sale for reasons of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 (§ 314.162).
Under § 314.161(a)(1), the agency
must determine whether a listed drug
was withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
PYRIDOSTIGMINE BROMIDE
(mestinon) tablets (NDA 009–829), 60
mg, were originally approved on April
6, 1955, to treat myasthenia gravis. They
were deemed effective under the Drug
Efficacy Study Implementation on
November 4, 1970 (35 FR 16992).
A suitability petition was submitted
under section 355(j)(2)(C) of the act and
was approved for a change in strength
for PYRIDOSTIGMINE BROMIDE
(mestinon) tablets (i.e., from 60-mg
tablets to 30-mg tablets) for the
treatment of myasthenia gravis (see
January 22, 1986, letter; Docket No.
1985P–0412). FDA approved ANDA 89–
572, held by Solvay Pharmaceuticals,
Inc., (Solvay), on November 27, 1990,
for PYRIDOSTIGMINE BROMIDE
tablets, 30 mg, for the treatment of
myasthenia gravis. Solvay’s
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, were discontinued from
marketing on May 12, 1994, and at
Solvay’s request, approval of ANDA 89–
572 was withdrawn effective August 11,
1994 (59 FR 35527, July 12, 1994).
On October 29, 2003, Lachman
Consultant Services, Inc., submitted a
citizen petition (Docket No. 2003P–
0501) under 21 CFR 10.30 requesting
that the agency determine whether
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, for the treatment of myasthenia
gravis, were withdrawn from sale for
reasons of safety or effectiveness.
The agency has determined that
PYRIDOSTIGMINE BROMIDE tablets,
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22:07 Jun 20, 2005
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30 mg, for the treatment of myasthenia
gravis, were not withdrawn from sale for
reasons of safety or effectiveness. The
original basis for approving the
suitability petition has not changed.
PYRIDOSTIGMINE BROMIDE
(mestinon) tablets, 60 mg, currently
appear in the active section of the
Orange Book. The agency notes that
PYRIDOSTIGMINE BROMIDE
(mestinon) tablets, 60 mg, are still being
marketed by several other
manufacturers (e.g., Impax Labs,
Corepharma, and Barr).
PYRIDOSTIGMINE BROMIDE
(mestinon) syrup (NDA 15–193), 60 mg/
5 milliliters, also appears in the active
section of the Orange Book. In
approving the suitability petition, the
agency noted that:
[a]lthough the proposed strength is less
than the currently approved product, the
labeling of the currently approved products
indicates that doses of 30 mg or even less
may be utilized. Additionally, incremental
doses are encouraged in approved labeling,
especially ‘‘for children and brittle
myasthenic patients who require fractions of
60-mg doses’’
(see Docket No. 1985P–0412). The
currently available, relevant information
does not call into question the agency’s
January 22, 1986, determination that
ANDAs for PYRIDOSTIGMINE
BROMIDE tablets, 30 mg, for the
treatment of myasthenia gravis, are
suitable for submission.
The agency notes that
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, are also indicated for
prophylaxis against the lethal effects of
soman nerve agent poisoning, and are
the subject of NDA 20–414. The U.S.
Army submitted NDA 20–414, which
was approved on February 5, 2003,
under subpart I of the new drug
regulations (§§ 314.600 through
314.650). NDA 20–414 is displayed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. Drug
products approved for the U.S. Army
are displayed in the discontinued
section of the Orange Book because they
are not commercially available. The
agency notes that NDA 20–414 is not the
subject of this determination. The issue
here is whether PYRIDOSTIGMINE
BROMIDE tablets, 30 mg, for the
treatment of myasthenia gravis (i.e.,
ANDA 89–572), were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing agency records, FDA
determines that, for the reasons stated in
this document, PYRIDOSTIGMINE
BROMIDE tablets, 30 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
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Fmt 4703
Sfmt 4703
agency will continue to list
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, for the treatment of myasthenia
gravis, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. ANDAs that refer to
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, for the treatment of myasthenia
gravis, may be approved by the agency.
Dated: June 14, 2005.
Jeffrey Shruen,
Assistant Commissioner for Policy.
[FR Doc. 05–12108 Filed 6–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0227]
Update on Leukocyte Reduction of
Blood and Blood Components; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Update on Leukocyte
Reduction of Blood and Blood
Components.’’ The public workshop
sponsors are FDA; the National
Institutes of Health (NIH) National
Heart, Lung, and Blood Institute
(NHLBI); and the Office of Public Health
and Science (OPHS) in the Department
of Health and Human Services. The
purpose of the public workshop is to
address current issues related to
leukocyte-reduced blood and blood
components.
Date and Time: The public workshop
will be held on July 20, 2005, from 8
a.m. to 5:30 p.m.
Location: The public workshop will
be held at the National Institutes of
Health, Lister Hill Center Auditorium,
Bldg. 38A, 8600 Rockville Pike,
Bethesda, MD 20894.
Contact: Rhonda Dawson, Center for
Biologics Evaluation and Research
(HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448, 301–827–
3514, FAX: 301–827–2843, e-mail:
dawsonr@cber.fda.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) to Rhonda Dawson (see
Contact) by July 1, 2005. Because
seating is limited, we recommend early
registration. Registration at the site on
the day of the public workshop will be
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35685
Federal Register / Vol. 70, No. 118 / Tuesday, June 21, 2005 / Notices
provided on a space available basis
beginning at 7:15 a.m. There is no
registration fee for the public workshop.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: FDA,
NHLBI, and OPHS are sponsoring a
public workshop entitled ‘‘Update on
Leukocyte Reduction of Blood and
Blood Components.’’ The workshop will
include the following topics:
• Leukoreduction in targeted and
non-targeted recipients;
• Current data on the potential
advantages and hazards ofproviding
leukocyte-reduced blood and blood
components;
• A review of observed clinical
adverse events and manufacturing
failures associated with leukoreduction
procedures;
• FDA’s current considerations for
regulatory standards for leukocytereduced components and approaches to
quality control testing; and
• New scientific developments in
filtration, including developing
technologies for prion removal from
blood components.
Transcripts: Transcripts of the public
workshop 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 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12185 Filed 6–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Prostate, Lung,
Colorectal and Ovarian Cancer
Screening Trial
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on January 24, 2005, page 3376
and allowed 60-days for public
comment. Three requests for more
information were received. Additional
information on the proposed collection
was sent to each requestor. The purpose
of this notice is to allow an additional
30 days for public comment.
5 CFR 1320.5 (General requirements)
Reporting and Recordkeeping
Requirements: Final Rule requires that
the agency inform the potential persons
who are to respond to the collection of
information that such persons are not
required to respond to the collection of
information unless it displays a
currently valid OMB control number.
This information is required to be stated
in the 30-day Federal Register Notice.
Proposed Collection: Title: Prostate,
Lung, Colorectal and Ovarian Cancer
Screening Trial. Type of Information
Collection Request: Revision, OMB
control number 0925–0407, expiration
date July 31, 2005. Need and Use of
Information Collection: This trial is
designed to determine if screening for
prostate, lung, colorectal and ovarian
cancer can reduce mortality from these
cancers which currently cause an
estimated 263,000 deaths annually in
the U.S. The design is a two-armed
randomized trial of men and women
aged 55 to 74 at entry. The total sample
size t is 154,938. The primary endpoint
of the trial is cancer-specific mortality
for each of the four cancer sites
(prostate, lung, colorectum, and ovary).
In addition, cancer incidence, stage
shift, and case survival are to be
monitored to help understand and
explain results. Biologic prognostic
characteristics of the cancers will be
measured and correlated with mortality
to determine the mortality predictive
value of these intermediate endpoints.
Basic demographic data, risk factor data
for the four cancer sites and screening
history data, as collected from all
subjects at baseline, will be used to
assure comparability between the
screening and control groups and make
appropriate adjustments in analysis.
Further, demographic and risk factor
information may be used to analyze the
differential effectiveness of screening in
high versus low risk individuals.
Frequency of Response: On occasion.
Affected Public: Individuals or
households. Type of Respondents: Adult
men and women. The annual reporting
burden is as follows: Estimated Number
of Respondents: 145,852; Estimated
Number of Responses Per Respondent:
1.14; Average Burden Hours Per
Response: 0.14; and Estimated Total
Annual Burden Hours Requested:
23,278. The annualized cost to
respondents is estimated at: $232,780.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Type of respondents
Estimated annual number
of respondents
Estimated
number of responses per
respondent
Average burden hours per
response
Estimated total
annual burden
hours requested
Adults ...............................................................................................................
145,852
1.14
0.14
23,278
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
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22:07 Jun 20, 2005
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burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(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 the use
of appropriate automated, electronic,
mechanical, or other technological
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collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
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21JNN1
]]>Agencies
[Federal Register Volume 70, Number 118 (Tuesday, June 21, 2005)]
[Notices]
[Pages 35684-35685]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12185]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0227]
Update on Leukocyte Reduction of Blood and Blood Components;
Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Update on Leukocyte Reduction of Blood and Blood
Components.'' The public workshop sponsors are FDA; the National
Institutes of Health (NIH) National Heart, Lung, and Blood Institute
(NHLBI); and the Office of Public Health and Science (OPHS) in the
Department of Health and Human Services. The purpose of the public
workshop is to address current issues related to leukocyte-reduced
blood and blood components.
Date and Time: The public workshop will be held on July 20, 2005,
from 8 a.m. to 5:30 p.m.
Location: The public workshop will be held at the National
Institutes of Health, Lister Hill Center Auditorium, Bldg. 38A, 8600
Rockville Pike, Bethesda, MD 20894.
Contact: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-3514, FAX: 301-827-2843, e-mail:
dawsonr@cber.fda.gov.
Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) to Rhonda Dawson (see
Contact) by July 1, 2005. Because seating is limited, we recommend
early registration. Registration at the site on the day of the public
workshop will be
[[Page 35685]]
provided on a space available basis beginning at 7:15 a.m. There is no
registration fee for the public workshop.
If you need special accommodations due to a disability, please
contact Rhonda Dawson at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA, NHLBI, and OPHS are sponsoring a public
workshop entitled ``Update on Leukocyte Reduction of Blood and Blood
Components.'' The workshop will include the following topics:
Leukoreduction in targeted and non-targeted recipients;
Current data on the potential advantages and hazards
ofproviding leukocyte-reduced blood and blood components;
A review of observed clinical adverse events and
manufacturing failures associated with leukoreduction procedures;
FDA's current considerations for regulatory standards for
leukocyte-reduced components and approaches to quality control testing;
and
New scientific developments in filtration, including
developing technologies for prion removal from blood components.
Transcripts: Transcripts of the public workshop 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 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12185 Filed 6-20-05; 8:45 am]
BILLING CODE 4160-01-S
