Determination of Regulatory Review Period for Purposes of Patent Extension; FASLODEX; Correction, 21029-21030 [E6-6083]
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21029
Federal Register / Vol. 71, No. 78 / Monday, April 24, 2006 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Illinois parent survey ........................................................................................
Oregon parent survey ......................................................................................
Estimated Total Annual Burden
Hours: 1,260
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
Number of
responses per
respondent
840
840
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
ACF. E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: April 17, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–3822 Filed 4–21–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Average
burden hours
per response
1
1
Total burden
hours
.75
.75
630
630
OMB No.: 0970–0204.
Description: On an annual basis,
States must provide OCSE with data on
programs that the Grants to States for
Access and Visitation Program has
funded. These program reporting
requirements include, but are not
limited to, the collection of data on the
number of parents served, types of
services delivered, program outcomes,
client socio-economic data, referral
sources, and other relevant data.
Respondents: State Child Access and
Visitation Programs and State and/or
local service providers.
Submission for OMB Review;
Comment Request
Title: Grants to States for Access and
Visitation: State Child Access Program
Survey.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
State Child Access Program Survey ...............................................................
rmajette on PROD1PC67 with NOTICES
Instrument
324
1
15
4,860
Estimated Total Annual Burden
Hours: 4,860.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
VerDate Aug<31>2005
14:56 Apr 21, 2006
Jkt 208001
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: April 17, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–3823 Filed 4–21–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E–0030]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; FASLODEX; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
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Register of April 17, 2003 (68 FR
18992). The document announced that
FDA had determined the regulatory
review period for FASLODEX. A request
for revision of regulatory review period
was filed for the product on June 16,
2003. FDA reviewed its records and
found that the effective date of the
investigational new drug application
(IND) was incorrect due to a clerical
error. Therefore, FDA is revising the
determination of the regulatory review
period to reflect the correct effective
date for the IND.
FOR FURTHER INFORMATION CONTACT:
Claudia V. Grillo, Office of Regulatory
Policy (HFD–13), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6681.
In FR Doc.
03–9536, appearing on page 18992 in
the Federal Register of April 17, 2003,
the following corrections are made:
1. On page 18992, in the second
column, in the second complete
SUPPLEMENTARY INFORMATION:
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24APN1
21030
Federal Register / Vol. 71, No. 78 / Monday, April 24, 2006 / Notices
paragraph, in the third line, ‘‘1,935’’ is
corrected to read ‘‘1,938’’; in the fourth
line, ‘‘1,541’’ is corrected to read
‘‘1,544’’.
2. On page 18992, in the second
column, in the third complete
paragraph, beginning in the fourth line,
‘‘January 8, 1997’’ is corrected to read
‘‘January 5, 1997’’; and the last two
sentences are corrected to read: ‘‘FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
January 5, 1997.’’
Dated: March 22, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–6083 Filed 4–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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.
Proposed Project: The National
Executive Training Institutes To Reduce
the Use of Seclusion and Restraint—
NEW
The Center for Mental Health Services
within the Substance Abuse and Mental
Health Services Administration
proposes to survey the recipients of the
training and technical assistance
provided through the National
Technical Assistance Center’s (NTAC)
National Executive Training Institutes
(NETI). The NETI was established to
assist states in the reduction and
elimination of seclusion and restraint
(S&R). Six Regional NETI training
events took place in 2003 and 2005. A
total of 47 states and staff of 80 facilities
were involved in the trainings. A NETI
Survey was developed to identify the
impact of the training on the
implementation of strategies for the
reduction of seclusion and restraint and
adoption of alternative practices.
The NETI Survey is broken into 9
sections: Section I collects general
information about the facility (name and
state) and the person completing the
questionnaire (name, title, phone
number, if participated in NETI training
and what NETI training participated in);
Section II collects information about the
type of facility or program that received
the NETI training; Section III collects
information about the types of persons
served by the facility or program; and
Sections IV though IX collect
information about the strategies taught
in the NETI training (Leadership, S/R
Prevention and Reduction Tools, Use of
S/R Data and Statistics, Staffing/
Workforce Development, Consumer/
Stakeholder Involvement, Barriers and
Facilitators and other comments),
specifically what strategies or changes
were implemented before the NETI
training, which were implemented after
the NETI training, and which have not
been implemented.
Among the data to be collected
through the NETI Survey is information
about the strategies taught in the NETI
training for reducing the use of
seclusion and restraint and adopting
alternative practices. The NETI training
has been accepted as a promising and
best practice for reducing the use of
seclusion and restraint, and as being on
the evidence-based practices ladder.
Current efforts are underway to move
the NETI training up the evidence-based
ladder to an effective practice. The use
of evidence-based practices is one of the
domains in the SAMHSA National
Outcome Measures (NOMs).
Respondents will have the option of
completing a paper or on-line version of
the survey. The estimated annual
response burden to collect this
information is as follows:
Number of facilities
Responses
per facility
Burden/
response
(hours)
Annual
burden
(hours)
80 .............................................................................................................................................................
1
1.50
120
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
rmajette on PROD1PC67 with NOTICES
Dated: April 13, 2006.
Anna Marsh,
Director, Office of Program Services.
[FR Doc. E6–6056 Filed 4–21–06; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
Notice of Cancellation of Customs
Broker License
ACTION:
General notice.
SUMMARY: Pursuant to section 641 of the
Tariff Act of 1930, as amended, (19
U.S.C. 1641) and the Customs
Regulations (19 CFR 111.51), the
following Customs broker licenses are
cancelled without prejudice.
Bureau of Customs and Border
Protection, U.S. Department of
Homeland Security.
AGENCY:
Name
License No.
M.G. Otero Co., Inc .........................................................................................................................................
Bernard M. Vas ................................................................................................................................................
VerDate Aug<31>2005
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Issuing port
Los Angeles.
San Francisco.
]]>Agencies
[Federal Register Volume 71, Number 78 (Monday, April 24, 2006)]
[Notices]
[Pages 21029-21030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6083]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E-0030]
Determination of Regulatory Review Period for Purposes of Patent
Extension; FASLODEX; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of April 17, 2003 (68 FR 18992).
The document announced that FDA had determined the regulatory review
period for FASLODEX. A request for revision of regulatory review period
was filed for the product on June 16, 2003. FDA reviewed its records
and found that the effective date of the investigational new drug
application (IND) was incorrect due to a clerical error. Therefore, FDA
is revising the determination of the regulatory review period to
reflect the correct effective date for the IND.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-13), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
SUPPLEMENTARY INFORMATION: In FR Doc. 03-9536, appearing on page 18992
in the Federal Register of April 17, 2003, the following corrections
are made:
1. On page 18992, in the second column, in the second complete
[[Page 21030]]
paragraph, in the third line, ``1,935'' is corrected to read ``1,938'';
in the fourth line, ``1,541'' is corrected to read ``1,544''.
2. On page 18992, in the second column, in the third complete
paragraph, beginning in the fourth line, ``January 8, 1997'' is
corrected to read ``January 5, 1997''; and the last two sentences are
corrected to read: ``FDA has verified the applicant's claim that the
date the investigational new drug application became effective was on
January 5, 1997.''
Dated: March 22, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-6083 Filed 4-21-06; 8:45 am]
BILLING CODE 4160-01-S
