Submission for OMB Review; Comment Request, 38169-38170 [06-5980]
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38169
Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: June 27, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–5978 Filed 7–3–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: OCSE–75 Tribal Child Support
Enforcement Program Annual Data
Report.
OCSE–75 .................................................................................
rwilkins on PROD1PC63 with NOTICES
9
Dated: June 27, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–5979 Filed 7–3–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Jkt 205001
2.5
Total burden
hours
22.5
Head Start Grantees and Current or
Prospective Delegate Agencies.
OMB No.: 0980–0242.
Description: Section 646 of the Head
Start Act requires the Secretary of
Health and Human Services to prescribe
a timeline for conducting administrative
hearings when adverse actions are taken
or proposed against Head Start and
Early Head Start grantees and delegate
agencies. The Office of Head Start is
proposing to renew, without changes,
this rule, which implements these
requirements and which prescribes
when a grantee must submit certain
information and what that information
shall include.
Respondents: Head Start and Early
Head Start grantees and Delegate
Agencies.
Annual Burden Estimates:
Submission for OMB Review;
Comment Request
Title: 45 CFR Part 1303—Appeal
Procedures for Head Start and Early
Number of respondents
Rule ..........................................................................................
19:34 Jul 03, 2006
Average burden
hours per response
1
agency’s estimate of the burden of the
proposed collection of information; (c)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Instrument
VerDate Aug<31>2005
Number of responses per respondent
Number of respondents
Instrument
Estimated Total Annual Burden
Hours: 22.5.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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. E-mail address:
infocollectionrsargis@acf.hhs.gov. All
requests should be sent to
infocollection@acf.hhs.gov identifying
the request by the title of the
information collection.
The Department specifically requests
comments 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
OMB No.: New Collection.
Description: The data collected by
form OCSE–75 are used to prepare the
OCSE preliminary and annual data
reports. In addition, Tribes
administering CSE programs under Title
IV–D of the Social Security Act are
required to report program status and
accomplishments and submit the
OCSE–75 report annually.
Respondents: Tribal Child Support
Enforcement Organizations or the
Department/Agency/Bureau responsible
for Child Support Enforcement in each
Tribe.
Annual Burden Estimates:
PO 00000
Frm 00042
20
Fmt 4703
Sfmt 4703
Number of responses per respondent
Average burden
hours per response
1
E:\FR\FM\05JYN1.SGM
26
05JYN1
Total burden
hours
520
38170
Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices
Estimated Total Annual Burden
Hours: 520.
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, 725 17th Street, NW.,
Washington, DC 20503, Attn: Desk
Officer for ACF. E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: June 26, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–5980 Filed 7–3–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0396]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for TAXUS
EXPRESS Paclitaxel-Eluting Coronary
Stent System and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
medical device.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
VerDate Aug<31>2005
19:34 Jul 03, 2006
Jkt 205001
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a medical device will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing
the medical device TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System. TAXUS EXPRESS PaclitaxelEluting Coronary Stent System is
indicated for improving luminal
diameter for the treatment of de novo
lesions ≤28 mm in length in native
coronary arteries ≥2.5 to ≤3.75 mm in
diameter. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System (U.S. Patent No. 5,716,981) from
Angiotech Phamaceuticals, Inc., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
restoration. In a letter dated February
24, 2006, FDA advised the Patent and
Trademark Office that this medical
device had undergone a regulatory
review period and that the approval of
TAXUS EXPRESS Paclitaxel-Eluting
Coronary Stent System represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
TAXUS EXPRESS Paclitaxel-Eluting
Coronary Stent System is 716 days. Of
this time, 456 days occurred during the
testing phase of the regulatory review
period, while 260 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act involving this device
became effective: March 21, 2002. The
applicant claims that the investigational
device exemption (IDE) required under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360j(g)) for human tests to begin became
effective on October 25, 2001. However,
FDA records indicate that the IDE was
determined substantially complete for
clinical studies to have begun on March
21, 2002, which represents the IDE
effective date.
2. The date the application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): June 19, 2003. The
applicant claims February 25, 2003, as
the date the premarket approval
application (PMA) for TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System (PMA P030025) was initially
submitted. However, FDA records
indicate that PMA P030025 was
submitted in modules and was not
substantially complete until the final
submission of clinical data on June 19,
2003.
3. The date the application was
approved: March 4, 2004. FDA has
verified the applicant’s claim that PMA
P030025 was approved on March 4,
2004.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 807 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
E:\FR\FM\05JYN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Notices]
[Pages 38169-38170]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: 45 CFR Part 1303--Appeal Procedures for Head Start and Early
Head Start Grantees and Current or Prospective Delegate Agencies.
OMB No.: 0980-0242.
Description: Section 646 of the Head Start Act requires the
Secretary of Health and Human Services to prescribe a timeline for
conducting administrative hearings when adverse actions are taken or
proposed against Head Start and Early Head Start grantees and delegate
agencies. The Office of Head Start is proposing to renew, without
changes, this rule, which implements these requirements and which
prescribes when a grantee must submit certain information and what that
information shall include.
Respondents: Head Start and Early Head Start grantees and Delegate
Agencies.
Annual Burden Estimates:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Rule................................ 20 1 26 520
----------------------------------------------------------------------------------------------------------------
[[Page 38170]]
Estimated Total Annual Burden Hours: 520.
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, 725 17th Street,
NW., Washington, DC 20503, Attn: Desk Officer for ACF. E-mail address:
Katherine--T.--Astrich@omb.eop.gov.
Dated: June 26, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06-5980 Filed 7-3-06; 8:45 am]
BILLING CODE 4184-01-M
