Proposed Information Collection Activity; Comment Request, 22749-22750 [E9-11149]
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22749
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices
Dated: May 6, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–11150 Filed 5–13–09; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; The Impact of Continuing
Medical Education on Physician
Practice
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Clinical Center, the National Institutes
of Health will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget for review and approval.
Proposed Collection: Title: The impact
of Continuing Medical Education on
physician practice: Type of Information
Collection Request: NEW. Need and Use
of Information Collection: This study
will assess the value of the Continuing
Medical Education conferences held at
the NIH. The primary objective of the
survey is to determine if conferences
have had an impact on whether the
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondents
physician has changed their practice as
a result of the information presented in
the conference. Frequency of response:
On occasion. Affected Public:
Physicians, dentists, nurses, and other
health care providers. The annual
reporting burden is as follows:
Average
burden hours
per response
Estimated total
annual burden
hours
requested
7,500
2,500
2
2
0.017
0.017
255
85
Total ..........................................................................................................
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Doctoral Level ..................................................................................................
Other Health Care Provider .............................................................................
........................
........................
........................
340
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) 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) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to 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
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Linda Wisniewski,
Nurse Consultant, Office of Clinical
Research Training and Medical
Education, CC, NIH, Building 10, Room
1N252B, 9000 Rockville Pike, Bethesda,
MD 20892 or 301–496–9425 or e-mail
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17:37 May 13, 2009
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your request, including your address to:
wisniewskil@cc.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Laura Lee,
Project Clearance Liaison, Warren Grant
Magnuson Clinical Center, National Institutes
of Health.
[FR Doc. E9–11308 Filed 5–13–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Title IV–E Programs Quarterly
Financial Report.
OMB No.: 0970–0205.
Description: Historically, State
agencies have administered programs
under title IV–E of the Social Security
Act for the Foster Care and Adoption
Assistance Programs. The
Administration for Children and
Families provides Federal funding at the
rate of 50 percent for most of the
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Fmt 4703
Sfmt 4703
administrative costs of these programs
and at other rates for other specific
categories of costs as detailed in Federal
statute and regulations.
The enactment of Public Law 110–
351, the ‘‘Fostering Connections to
Success and Increasing Adoptions Act
of 2008’’ introduced two major changes
to the title IV–E programs: (1) The
inception of the Guardianship
Assistance Program for all grantees,
effective October 1, 2008 and, (2) the
availability of these programs to Tribes
and Tribal Organizations, effective
October 1, 2009.
We anticipate that this form will be
revised and redesigned to be applicable
to both State and Tribal grantees.
This form is submitted quarterly by
each State or Tribe to estimate its
funding needs for the upcoming fiscal
quarter and to report expenditures for
the fiscal quarter just ended. The
information collected in this report is
used by this agency to calculate
quarterly Federal grant awards and to
enable oversight of the financial
management of the programs.
Respondents: State agencies
(including the District of Columbia and
Puerto Rico) and Tribal agencies
(starting in FY 2010) administering the
Foster Care, Adoption Assistance and
Guardianship Assistance programs
under Title IV–E of the Social Security
Act.
E:\FR\FM\14MYN1.SGM
14MYN1
22750
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Title IV–E Programs Quarterly Financial Report .............................................
70
4
20
5,600
Estimated Total Annual Burden
Hours: 5,600.
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:
grjohnson@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: May 6, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–11149 Filed 5–13–09; 8:45 am]
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BILLING CODE 4184–01–M
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17:37 May 13, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2004–E–0266 (formerly
2004E–0446), FDA–2004–E–0270 (formerly
2004E–0391), and FDA–2004–E–0332
(formerly 2004E–0399)]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SENSIPAR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SENSIPAR 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 human drug product.
ADDRESSES: Submit written comments
and petitions 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.regulations.gov
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
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
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an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the drug product. 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 (for
example, 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 human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product SENSIPAR
(cinacalcet hydrochloride). SENSIPAR
is indicated for the treatment of
secondary hyperparathyroidism in
patients with chronic kidney disease on
dialysis and for the treatment of
hypercalcemia in patients with
parathyroid carcinoma. Subsequent to
this approval, the Patent and Trademark
Office received patent term restoration
applications for SENSIPAR (U.S. Patent
Nos. 6,011,068; 6,211,244; and
6,313,146) from NPS Pharmaceuticals,
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibilities for
patent term restoration. In a letter dated
October 19, 2004, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of SENSIPAR represented the
first permitted commercial marketing or
use of the product. Shortly 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
SENSIPAR is 2,089 days. Of this time,
1,906 days occurred during the testing
phase of the regulatory review period,
while 183 days occurred during the
approval phase. These periods of time
were derived from the following dates:
E:\FR\FM\14MYN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 92 (Thursday, May 14, 2009)]
[Notices]
[Pages 22749-22750]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11149]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Title IV-E Programs Quarterly Financial Report.
OMB No.: 0970-0205.
Description: Historically, State agencies have administered
programs under title IV-E of the Social Security Act for the Foster
Care and Adoption Assistance Programs. The Administration for Children
and Families provides Federal funding at the rate of 50 percent for
most of the administrative costs of these programs and at other rates
for other specific categories of costs as detailed in Federal statute
and regulations.
The enactment of Public Law 110-351, the ``Fostering Connections to
Success and Increasing Adoptions Act of 2008'' introduced two major
changes to the title IV-E programs: (1) The inception of the
Guardianship Assistance Program for all grantees, effective October 1,
2008 and, (2) the availability of these programs to Tribes and Tribal
Organizations, effective October 1, 2009.
We anticipate that this form will be revised and redesigned to be
applicable to both State and Tribal grantees.
This form is submitted quarterly by each State or Tribe to estimate
its funding needs for the upcoming fiscal quarter and to report
expenditures for the fiscal quarter just ended. The information
collected in this report is used by this agency to calculate quarterly
Federal grant awards and to enable oversight of the financial
management of the programs.
Respondents: State agencies (including the District of Columbia and
Puerto Rico) and Tribal agencies (starting in FY 2010) administering
the Foster Care, Adoption Assistance and Guardianship Assistance
programs under Title IV-E of the Social Security Act.
[[Page 22750]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Title IV-E Programs Quarterly Financial 70 4 20 5,600
Report.....................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 5,600.
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: grjohnson@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: May 6, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9-11149 Filed 5-13-09; 8:45 am]
BILLING CODE 4184-01-M
