Proposed Collection; Comment Request; ODS Assessment of Dietary Supplement Education, 20410-20411 [E6-5922]
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20410
Federal Register / Vol. 71, No. 76 / Thursday, April 20, 2006 / Notices
approximately 15 working days after the
meeting at a cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The ICH
was established in 1990 as a joint
regulatory/industry project to improve,
through harmonization, the efficiency of
the process for developing and
registering new medicinal products in
Europe, Japan and the United States
without compromising the regulatory
obligations of safety and effectiveness.
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization, and FDA is committed
to seeking scientifically based
harmonized technical procedures for
pharmaceutical development. One of
the goals of harmonization is to identify
and then reduce differences in technical
requirements for medical product
development among regulatory
agencies. ICH was organized to provide
an opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. ICH is concerned with
harmonization among three regions: The
European Union, Japan, and the United
States. The six ICH sponsors are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labor and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and Health Canada, the
European Free Trade Area and the
World Health Organization. The ICH
process has achieved significant
harmonization of the technical
requirements for the approval of
pharmaceuticals for human use in the
three ICH regions.
The current ICH process and structure
can be found at the following Web site:
https://www.ich.org.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Oral presentations from the
public will be scheduled between
approximately 11:30 a.m. and 12:30
p.m. Time allotted for oral presentations
may be limited to 10 minutes. Those
desiring to make oral presentations
should notify the contact person by May
1, 2006, and submit a brief statement of
the general nature of the evidence or
arguments they which to present, the
names and addresses, phone number,
fax, and e-mail of proposed participants,
and an indication of the approximate
time requested to make their
presentation.
The agenda for the public meeting
will be made available on April 24,
2006, on the Internet at https://
www.fda.gov/cder/meeting/
ICH_20060508.htm.
Dated: April 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–5905 Filed 4–19–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; ODS Assessment of Dietary
Supplement Education
SUMMARY: The proposed information
collection described below will be
submitted to the Office of Management
and Budget (OMB) for review and
approval, as required by the Paperwork
Reduction Act of 1995. In compliance
with the requirement of Section
Estimated
number of
respondents
Type of respondents
3506(c)(2)(A) of the Paperwork
Reduction Act, for opportunity for
public comment on proposed data
collection projects, the Office of Dietary
Supplements (ODS), at the National
Institutes of Health (NIH) is soliciting
public comments on the subject
proposal.
Proposed Collection
Title: ODS Assessment of Dietary
Supplement Education.
Type of Information Collection
Request: New data collection.
Need and Use of Information
Collection: The mission of ODS is to
strengthen knowledge and
understanding of dietary supplements
by evaluating scientific information,
stimulating and supporting research,
disseminating research results, and
educating the public to foster an
enhanced quality of life and health for
the U.S. population. To assist ODS in
prioritizing educational and training
needs for researchers in the field, ODS
is requesting OMB Clearance for a
survey of members of academic health
institutions. This effort involves a dual
method (mail/Web) survey consisting of
nine questions (including four two-part
questions), which will be attempted
with an estimated 2600 individuals at
approximately 1000 academic
institutions, yielding an annual total of
approximately 1820 respondents (based
on a 70 percent response rate). The
survey results will help ODS in
measuring the scope of higher
education’s curriculum on dietary
supplements, identifying gaps in dietary
supplement education, and determining
the level of interest in potential ODS
seminars and programs, and the specific
content needs.
Frequency of Response: This is a onetime data collection.
Affected Public: Academic
institutions.
Type of Respondents: Faculty
members at academic institutions.
The annual reporting burden is as
follows.
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Telephone or web survey completion
hsrobinson on PROD1PC61 with NOTICES
Individuals at academic institutions .................................................................
1820
1
0.12
218
1
0.25
455
Review of course information for survey completion
Individuals at academic institutions .................................................................
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1820
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Federal Register / Vol. 71, No. 76 / Thursday, April 20, 2006 / Notices
Estimated
number of
respondents
Type of respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Collection and submission of materials
Individuals at academic institutions .................................................................
910
1
0.50
455
Annualized totals ......................................................................................
1820
........................
........................
1128
The annualized cost to respondents is
estimated at $31,978.86, $6,189.46 for
survey completion, and $12,894.70 for
the review of course information and
collection and submission of materials,
respectively.
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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Paul M. Coates,
Director, Office of Dietary Supplements,
National Institutes of Health, Suite
3B01, 6100 Executive Boulevard,
Bethesda, MD 20892–7517; or fax your
request to 301–480–1845; or e-mail
ods@nih.gov. Dr. Coates can be
contacted by telephone at 301–435–
2920.
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.
hsrobinson on PROD1PC61 with NOTICES
FOR FURTHER INFORMATION CONTACT:
Dated: April 13, 2006.
Paul M. Coates,
Director, Office of Dietary Supplements,
National Institutes of Health.
[FR Doc. E6–5922 Filed 4–19–06; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Liaison and Scientific Review Office;
Meeting of the NTP Board of Scientific
Counselors
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Meeting announcement and
request for comments
AGENCY:
SUMMARY: Pursuant to Public Law 92–
463, notice is hereby given of a meeting
of the NTP Board of Scientific
Counselors (NTP BSC). The NTP BSC is
composed of scientists from the public
and private sectors and provides
primary scientific oversight to the
Director for the NTP and evaluates the
scientific merit of the NTP’s intramural
and collaborative programs.
DATES: The NTP BSC meeting will be
held on June 13, 2006. In order to
facilitate planning for this meeting,
persons wishing to make an oral
presentation are asked to notify the
Executive Secretary for the NTP BSC by
May 31, 2006 (see FOR FURTHER
INFORMATION CONTACT below). Written
comments should also be received by
May 31, 2006, to enable review by the
NTP BSC and NIEHS/NTP staff prior to
the meeting. Persons needing special
assistance, such as sign language
interpretation or other reasonable
accommodation in order to attend,
should contact 919–541–2475 (voice),
919–541–4644 TTY (text telephone),
through the Federal TTY Relay System
at 800–877–8339, or by e-mail to
niehsoeeo@niehs.nih.gov. Requests
should be made at least 7 days in
advance of the event.
ADDRESSES: The NTP BSC meeting will
be held in the Rodbell Auditorium, Rall
Building at the National Institute of
Environmental Health Sciences, 111 T.
W. Alexander Drive, Research Triangle
Park, NC 27709.
FOR FURTHER INFORMATION CONTACT:
Public comments and any other
correspondence should be submitted to
Dr. Barbara Shane, Executive Secretary
for the NTP Board (NTP Liaison and
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Scientific Review Office, NIEHS, P.O.
Box 12233, MD A3–01, Research
Triangle Park, NC 27709; telephone:
919–541–4253, fax: 919–541–0295; or email: shane@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Preliminary Agenda Topics and
Availability of Meeting Materials
Preliminary agenda topics are as
follows:
• NIEHS Strategic Plan.
• Update of NTP Activities.
• NTP BSC’s Technical Report
Review Subcommittee Report.
• NTP Testing Nominations.
A copy of the preliminary agenda,
committee roster, and any additional
information, when available, will be
posted on the NTP Web site or may be
requested in hardcopy from the
Executive Secretary for the NTP BSC
(see FOR FURTHER INFORMATION CONTACT
above). Following the meeting,
summary minutes will be prepared and
made available on the NTP Web site.
Attendance and Registration
The meeting is scheduled for June 13,
2006, from 8:30 a.m. to adjournment
and is open to the public with
attendance limited only by the space
available. Individuals who plan to
attend are encouraged to register online
at the NTP Web site by May 31, 2006,
to facilitate access to the NIEHS
campus. Please note that a photo ID is
required to access the NIEHS campus.
The NTP is making plans to videocast
the meeting through the Internet at
https://www.niehs.nih.gov/external/
video.htm.
Request for Comments
Time is allotted during the meeting
for the public to present comment to the
NTP BSC and NTP staff on the agenda
topics. Each organization is allowed one
time slot per agenda topic. At least 7
minutes will be allotted to each speaker,
and if time permits, may be extended to
10 minutes. Registration for oral
comments will also be available on-site,
although time allowed for presentation
by on-site registrants may be less than
that for pre-registered speakers and will
be determined by the number of persons
who register at the meeting.
E:\FR\FM\20APN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 76 (Thursday, April 20, 2006)]
[Notices]
[Pages 20410-20411]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; ODS Assessment of Dietary
Supplement Education
SUMMARY: The proposed information collection described below will be
submitted to the Office of Management and Budget (OMB) for review and
approval, as required by the Paperwork Reduction Act of 1995. In
compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act, for opportunity for public comment on proposed
data collection projects, the Office of Dietary Supplements (ODS), at
the National Institutes of Health (NIH) is soliciting public comments
on the subject proposal.
Proposed Collection
Title: ODS Assessment of Dietary Supplement Education.
Type of Information Collection Request: New data collection.
Need and Use of Information Collection: The mission of ODS is to
strengthen knowledge and understanding of dietary supplements by
evaluating scientific information, stimulating and supporting research,
disseminating research results, and educating the public to foster an
enhanced quality of life and health for the U.S. population. To assist
ODS in prioritizing educational and training needs for researchers in
the field, ODS is requesting OMB Clearance for a survey of members of
academic health institutions. This effort involves a dual method (mail/
Web) survey consisting of nine questions (including four two-part
questions), which will be attempted with an estimated 2600 individuals
at approximately 1000 academic institutions, yielding an annual total
of approximately 1820 respondents (based on a 70 percent response
rate). The survey results will help ODS in measuring the scope of
higher education's curriculum on dietary supplements, identifying gaps
in dietary supplement education, and determining the level of interest
in potential ODS seminars and programs, and the specific content needs.
Frequency of Response: This is a one-time data collection.
Affected Public: Academic institutions.
Type of Respondents: Faculty members at academic institutions.
The annual reporting burden is as follows.
----------------------------------------------------------------------------------------------------------------
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 or web survey completion
----------------------------------------------------------------------------------------------------------------
Individuals at academic institutions............ 1820 1 0.12 218
----------------------------------------------------------------------------------------------------------------
Review of course information for survey completion
----------------------------------------------------------------------------------------------------------------
Individuals at academic institutions............ 1820 1 0.25 455
----------------------------------------------------------------------------------------------------------------
[[Page 20411]]
Collection and submission of materials
----------------------------------------------------------------------------------------------------------------
Individuals at academic institutions............ 910 1 0.50 455
----------------------------------------------------------------------------------------------------------------
Annualized totals........................... 1820 .............. .............. 1128
----------------------------------------------------------------------------------------------------------------
The annualized cost to respondents is estimated at $31,978.86,
$6,189.46 for survey completion, and $12,894.70 for the review of
course information and collection and submission of materials,
respectively.
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.
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 Dr. Paul M. Coates, Director, Office of Dietary
Supplements, National Institutes of Health, Suite 3B01, 6100 Executive
Boulevard, Bethesda, MD 20892-7517; or fax your request to 301-480-
1845; or e-mail ods@nih.gov. Dr. Coates can be contacted by telephone
at 301-435-2920.
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.
Dated: April 13, 2006.
Paul M. Coates,
Director, Office of Dietary Supplements, National Institutes of Health.
[FR Doc. E6-5922 Filed 4-19-06; 8:45 am]
BILLING CODE 4140-01-P
