Agency Forms Undergoing Paperwork Reduction Act Review, 73008-73009 [E5-7040]
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Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Respondents
Web site Users ........................................................................................
Dated: December 2, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7039 Filed 12–7–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-06–05BF)
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–4766 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Human Smoking Behavior—New—
National Center for Chronic Disease and
Public Health Promotion (NCDDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC, National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), in a joint
venture with the National Center for
Environmental Health (NCEH), proposes
to conduct a 2-year laboratory-based
study of human smoking behavior
Number of
responses per
respondent
400,000
among established current smokers of
the major styles and varieties of
cigarettes consumed in the United
States. This study will compare how
different categories of cigarettes deliver
toxic chemicals to smokers in order to
further investigate the link between
tobacco use and disease.
The major objective of this study is to
better understand how human and
cigarette variables influence the
delivered dose of harmful chemicals in
smoke to identify risk factors that result
in adverse health effects from smoking.
The smoking behavior and biomarkers
of 360 smokers will be ascertained.
Participants will attend two sessions on
consecutive days. Solanesol levels in
cigarette filter butts; carbon monoxide
boost in breath; carcinogens and
nicotine and its metabolites in urine;
cotinine in saliva; vent-blocking (as
measured by filter stain pattern and
visualization of lip and finger placement
on the rod using fluorescent markers);
smoking topography; and breathing
patterns (inhalation and exhalation
volume, breath velocity and duration
prior to smoking, during smoking and
after smoking) will be used to measure
dose based on the number of cigarettes
smoked, amount of each cigarette
smoked, filter vent blocking behavior,
smoking behavior and puff
characteristics.
Another objective of this study is to
define average or ‘‘composite’’ smoking
patterns across several of the most
popular cigarette categories (ultralight,
light, full-flavored menthol and fullflavored non-menthol) from the
quantitative and observational data. All
current smoking machine
methodologies are ‘‘one size fits all’’
approaches to generating cigarette
smoke. The composite conditions can be
used to establish human behavior-based
smoking machine methods for
1
Average
burden per
response
(in hours)
Total annual
burden
(in hours)
6/60
40,000
laboratory studies that require cigarette
smoke for chemical or toxicological
testing. Currently, laboratory scientists
rely on automated smoking machines to
generate cigarette smoke for chemical
and toxicological testing.
Funding for this study will come from
both NCCDPHP and NCEH. The Centers
will share responsibilities, with
administrative and technical assistance
coming from NCCDPHP and laboratory
support coming from NCEH.
This is a two-year study, and an
estimated 500 respondents will be
screened by telephone to yield 360
eligible respondents who complete both
visits over the two-year study period.
The total burden for each respondent
who completes screening, visit 1 and
visit 2 will be two hours and five
minutes. The CATI screening will take
five minutes. Visit 1 will take one hour,
which includes a short screening item,
the informed consent process, biologic
sample collection (urine, saliva, and
breath carbon monoxide), smoking
topography, ventilation hole blocking
procedure and breath measurements.
Visit 2 will also take approximately one
hour, which includes compensation,
discussion of quit opportunities if
requested, collection of cigarette butts,
biologic sample collection (urine, saliva,
and breath carbon monoxide), smoking
topography, ventilation hole blocking
procedure and breath measurements.
The following table summarizes
burden on an annualized basis for 500
telephone interviews and 180 eligible
respondents (one-half of the total
respondents). The 180 eligible
respondents estimated to complete visit
2 are the same respondents estimated to
complete visit 1.
There are no costs to the respondents
other than their time. The total
estimated annualized burden hours are
402.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Respondents
Procedure
Smokers ..........................................................
Eligible Smokers .............................................
Eligible Smokers .............................................
CATI Screening ..............................................
Visit 1, (Day 1) ...............................................
Visit 2, (Day 2) ...............................................
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500
180
180
08DEN1
Number of
responses per
respondent
1
1
1
Average
burden per
response
(in hours)
42
180
180
Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices
Dated: December 1, 2005.
Joan Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7040 Filed 12–7–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0457]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notice of a Claim
for Generally Recognized as Safe
Exemption Based on a Generally
Recognized as Safe Determination
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
[Docket No. 2005N–0186]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
State Enforcement Notifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘State Enforcement Notifications’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In the
Federal Register of September 14, 2005
(70 FR 54393), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0275. The
approval expires on November 30, 2008.
A copy of the supporting statement for
this information collection is available
on the Internet at ‘‘https://www.fda.gov/
ohrms/dockets’’.
SUPPLEMENTARY INFORMATION:
Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23744 Filed 12–7–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
16:29 Dec 07, 2005
Food and Drug Administration,
HHS.
Jkt 208001
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the procedures used for submitting a
Generally Recognized as Safe (GRAS)
notice stating that a particular use of a
substance is not subject to the premarket
approval requirements of the Federal
Food, Drug, and Cosmetic Act (the act).
DATES: Submit written or electronic
comments on the collection of
information by February 6, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
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73009
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Notice of a Claim for GRAS Exemption
Based on a GRAS Determination—21
CFR 170.36 and 570.36 (OMB Control
Number 0910–0342)—Extension
Section 409 of the act (21 U.S.C. 348)
establishes a premarket approval
requirement for ‘‘food additives;’’
section 201(s) of the act (21 U.S.C.
321(s)) provides an exemption from the
definition of ‘‘food additive’’ and thus
from the premarket approval
requirement, for uses of substances that
are GRAS by qualified experts. FDA is
proposing a voluntary procedure
whereby members of the food industry
who determine that use of a substance
satisfies the statutory exemption may
notify FDA of that determination. The
notice would include a detailed
summary of the data and information
that support the GRAS determination,
and the notifier would maintain a
record of such data and information.
FDA would make the information
describing the GRAS claim, and the
agency’s response to the notice,
available in a publicly accessible file;
the entire GRAS notice would be
publicly available consistent with the
Freedom of Information Act and other
Federal disclosure statutes.
Description of Respondents:
Manufacturers of Substances Used in
Food and Feed.
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 70, Number 235 (Thursday, December 8, 2005)]
[Notices]
[Pages 73008-73009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7040]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-06-05BF)
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-4766 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Human Smoking Behavior--New--National Center for Chronic Disease
and Public Health Promotion (NCDDPHP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC, National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP), in a joint venture with the National Center for
Environmental Health (NCEH), proposes to conduct a 2-year laboratory-
based study of human smoking behavior among established current smokers
of the major styles and varieties of cigarettes consumed in the United
States. This study will compare how different categories of cigarettes
deliver toxic chemicals to smokers in order to further investigate the
link between tobacco use and disease.
The major objective of this study is to better understand how human
and cigarette variables influence the delivered dose of harmful
chemicals in smoke to identify risk factors that result in adverse
health effects from smoking. The smoking behavior and biomarkers of 360
smokers will be ascertained. Participants will attend two sessions on
consecutive days. Solanesol levels in cigarette filter butts; carbon
monoxide boost in breath; carcinogens and nicotine and its metabolites
in urine; cotinine in saliva; vent-blocking (as measured by filter
stain pattern and visualization of lip and finger placement on the rod
using fluorescent markers); smoking topography; and breathing patterns
(inhalation and exhalation volume, breath velocity and duration prior
to smoking, during smoking and after smoking) will be used to measure
dose based on the number of cigarettes smoked, amount of each cigarette
smoked, filter vent blocking behavior, smoking behavior and puff
characteristics.
Another objective of this study is to define average or
``composite'' smoking patterns across several of the most popular
cigarette categories (ultralight, light, full-flavored menthol and
full-flavored non-menthol) from the quantitative and observational
data. All current smoking machine methodologies are ``one size fits
all'' approaches to generating cigarette smoke. The composite
conditions can be used to establish human behavior-based smoking
machine methods for laboratory studies that require cigarette smoke for
chemical or toxicological testing. Currently, laboratory scientists
rely on automated smoking machines to generate cigarette smoke for
chemical and toxicological testing.
Funding for this study will come from both NCCDPHP and NCEH. The
Centers will share responsibilities, with administrative and technical
assistance coming from NCCDPHP and laboratory support coming from NCEH.
This is a two-year study, and an estimated 500 respondents will be
screened by telephone to yield 360 eligible respondents who complete
both visits over the two-year study period. The total burden for each
respondent who completes screening, visit 1 and visit 2 will be two
hours and five minutes. The CATI screening will take five minutes.
Visit 1 will take one hour, which includes a short screening item, the
informed consent process, biologic sample collection (urine, saliva,
and breath carbon monoxide), smoking topography, ventilation hole
blocking procedure and breath measurements. Visit 2 will also take
approximately one hour, which includes compensation, discussion of quit
opportunities if requested, collection of cigarette butts, biologic
sample collection (urine, saliva, and breath carbon monoxide), smoking
topography, ventilation hole blocking procedure and breath
measurements.
The following table summarizes burden on an annualized basis for
500 telephone interviews and 180 eligible respondents (one-half of the
total respondents). The 180 eligible respondents estimated to complete
visit 2 are the same respondents estimated to complete visit 1.
There are no costs to the respondents other than their time. The
total estimated annualized burden hours are 402.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondents Procedure respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Smokers............................... CATI Screening.......... 500 1 42
Eligible Smokers...................... Visit 1, (Day 1)........ 180 1 180
Eligible Smokers...................... Visit 2, (Day 2)........ 180 1 180
----------------------------------------------------------------------------------------------------------------
[[Page 73009]]
Dated: December 1, 2005.
Joan Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E5-7040 Filed 12-7-05; 8:45 am]
BILLING CODE 4163-18-P
