Proposed Collection; Comment Request; NCCAM Customer Service Data Collection, 45862-45863 [E9-21479]
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45862
Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices
Assessment of Fall Prevention
Programs. This approval expires on
7/31/10. At this time we are requesting
a two year extension to collect data.
NCIPC seeks to examine cost of
implementing each of the three AoAfunded fall prevention programs for
older adults (Stepping On, Moving for
Better Balance and Matter of Balance)
and to assess the maintenance of fall
prevention behaviors among
participants six months after completing
the Matter of Balance program.
To assess the maintenance of fall
prevention behaviors, CDC’s contractor,
Booz Allen Hamilton, will conduct
telephone interviews of 300 Matter of
Balance program participants six
months after they have completed the
program. The interview will assess their
knowledge and self-efficacy related to
falls as taught in the course, their
activity and exercise levels, and their
reported falls both before and after the
program. The results of the follow-up
assessment will determine the extent to
which preventive behaviors learned
during the Matter of Balance program
are maintained and can continue to
reduce fall risk.
The cost assessment will calculate the
lifecycle cost of the Stepping On,
Moving for Better Balance, and Matter of
Balance programs. The cost analysis
will include calculating the investment
costs required to implement each
program, as well as the ongoing
operational costs associated with each
program. These costs will be allocated
over a defined period of time,
depending on the average or standard
amount of time these programs continue
to operate (standard lifecycle analysis
ranges from five to 10 years). The data
obtained from the lifecycle cost
calculation will allow us to compare
program costs and to identify specific
cost drivers, cost risks, and unique
financial attributes of each program.
Local program coordinators for the
200 sites in each of the AoA-funded
states will collect the cost data using
lifecycle cost spreadsheets that will be
returned to CDC’s contractor for
analysis. Booz Allen Hamilton has been
contracted by CDC to conduct the data
collection and analysis.
The results of these studies will
support the replication and
dissemination of these fall prevention
programs and enable them to reach
more older adults. States require data on
impact and cost in order to obtain
sustainable and supplemental funding
to maintain programs after funding from
AoA ends.
There are no costs to respondents
other than their time.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden
per response
(in hours)
Number of
responses
Total burden
(in hours)
Type of respondent
Form name
Program Coordinators .......................
Program Participants ........................
Cost Assessment .............................
Impact Survey ..................................
200
300
1
1
2
1
400
300
Total ...........................................
...........................................................
........................
........................
........................
700
Dated: August 28, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–21377 Filed 9–3–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection
srobinson on DSKHWCL6B1PROD with NOTICES
Proposed Collection; Comment
Request; NCCAM Customer Service
Data Collection
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Center for Complementary and
Alternative Medicine (NCCAM), the
National Institutes of Health (NIH), will
submit to the Office of Management and
Budget (OMB) a request for review and
approval of the information collection
listed below. A notice of this proposed
information collection was previously
published in the Federal Register on
VerDate Nov<24>2008
17:16 Sep 03, 2009
Jkt 217001
June 26, 2009 (Volume 74, Number 122,
page 30577). To date, no public
comments have been received. The
purpose of this notice is to announce a
final 30 days for public comment. NIH
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Title: NCCAM Customer Service Data
Collection.
Type of Information Collection
Request: Revision.
Need and Use of Information
Collection: NCCAM provides the public,
patients, families, health care providers,
complementary and alternative
medicine (CAM) practitioners, and
others with the latest scientifically
based information on CAM and
information about NCCAM’s programs
through a variety of channels, including
its toll-free telephone information
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
service. NCCAM wishes to continue to
measure customer satisfaction with
NCCAM telephone interactions and to
assess which audiences are being
reached through these channels. This
effort involves a telephone survey
consisting of 10 questions, which 25
percent of all callers are asked to
answer, for an annual total of
approximately 983 respondents.
NCCAM uses the data collected from the
survey to help program staff measure
the impact of their communication
efforts, tailor services to the public and
health care providers, measure service
use among special populations, and
assess the most effective media and
messages to reach these audiences.
Frequency of Response: Once.
Affected Public: Individuals and
households.
Type of Respondents: Patients,
spouses/family/friends of patients,
health care providers, physicians, CAM
practitioners, or other individuals
contacting the NCCAM Clearinghouse.
The annual reporting burden is as
follows:
E:\FR\FM\04SEN1.SGM
04SEN1
45863
Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices
A.12–1—ESTIMATES OF HOUR BURDEN
Estimated
number of
respondents
Type of respondents
srobinson on DSKHWCL6B1PROD with NOTICES
Telephone survey
Individuals or households ................................................................................
Physicians ........................................................................................................
CAM/health practitioners .................................................................................
The annualized cost to respondents is
estimated at $1,479 for the telephone
survey. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on 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; (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.
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,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Christy
Thomsen, Director, Office of
Communications and Public Liaison,
NCCAM, 31 Center Drive, Room 2B–11,
Bethesda, MD 20892–2182; or fax your
request to 301–402–4741; or e-mail
thomsenc@mail.nih.gov. Ms. Thomsen
can be contacted by telephone at 301–
451–8876.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
VerDate Nov<24>2008
17:16 Sep 03, 2009
Jkt 217001
919
44
20
Dated: August 27, 2009.
Christy Thomsen,
Director, Office of Communications and
Public Liaison, National Center for
Complementary and Alternative Medicine,
National Institutes of Health.
[FR Doc. E9–21479 Filed 9–3–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0266]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; DORIBAX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
DORIBAX 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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
Estimated
number of
responses per
respondent
1
1
1
Average
burden hours
per response
0.075
0.075
0.075
Estimated total
annual burden
hours
requested
69
3
1
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 human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug 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 DORIBAX
(doripenem monohydrate). DORIBAX is
indicated in the treatment of the
following infections caused by
designated susceptible bacteria:
complicated intra-abdominal infections,
and complicated urinary tract
infections, including pyelonephritis.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
DORIBAX (U.S. Patent No. 5,317,016)
from Shionogi Seiyaku Kabushiki
Kaisha, and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
February 18, 2009, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 74, Number 171 (Friday, September 4, 2009)]
[Notices]
[Pages 45862-45863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21479]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; NCCAM Customer Service Data
Collection
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Center for Complementary and
Alternative Medicine (NCCAM), the National Institutes of Health (NIH),
will submit to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. A
notice of this proposed information collection was previously published
in the Federal Register on June 26, 2009 (Volume 74, Number 122, page
30577). To date, no public comments have been received. The purpose of
this notice is to announce a final 30 days for public comment. NIH may
not conduct or sponsor, and the respondent is not required to respond
to, an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Proposed Collection
Title: NCCAM Customer Service Data Collection.
Type of Information Collection Request: Revision.
Need and Use of Information Collection: NCCAM provides the public,
patients, families, health care providers, complementary and
alternative medicine (CAM) practitioners, and others with the latest
scientifically based information on CAM and information about NCCAM's
programs through a variety of channels, including its toll-free
telephone information service. NCCAM wishes to continue to measure
customer satisfaction with NCCAM telephone interactions and to assess
which audiences are being reached through these channels. This effort
involves a telephone survey consisting of 10 questions, which 25
percent of all callers are asked to answer, for an annual total of
approximately 983 respondents. NCCAM uses the data collected from the
survey to help program staff measure the impact of their communication
efforts, tailor services to the public and health care providers,
measure service use among special populations, and assess the most
effective media and messages to reach these audiences.
Frequency of Response: Once.
Affected Public: Individuals and households.
Type of Respondents: Patients, spouses/family/friends of patients,
health care providers, physicians, CAM practitioners, or other
individuals contacting the NCCAM Clearinghouse.
The annual reporting burden is as follows:
[[Page 45863]]
A.12-1--Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Telephone survey
Individuals or households....................... 919 1 0.075 69
Physicians...................................... 44 1 0.075 3
CAM/health practitioners........................ 20 1 0.075 1
----------------------------------------------------------------------------------------------------------------
The annualized cost to respondents is estimated at $1,479 for the
telephone survey. There are no Capital Costs to report. There are no
Operating or Maintenance Costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on 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;
(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.
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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Christy Thomsen, Director, Office of
Communications and Public Liaison, NCCAM, 31 Center Drive, Room 2B-11,
Bethesda, MD 20892-2182; or fax your request to 301-402-4741; or e-mail
thomsenc@mail.nih.gov. Ms. Thomsen can be contacted by telephone at
301-451-8876.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: August 27, 2009.
Christy Thomsen,
Director, Office of Communications and Public Liaison, National Center
for Complementary and Alternative Medicine, National Institutes of
Health.
[FR Doc. E9-21479 Filed 9-3-09; 8:45 am]
BILLING CODE 4140-01-P
