Proposed Data Collections Submitted for Public Comment and Recommendations, 53876-53877 [E8-21690]
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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Notices
For Further Information Contact:
Sandra M. Peay, Contact Representative,
or Renee Hallman, Contact
Representative, Federal Trade
Commission, Premerger Notification
Office, Bureau Of Competition, Room
H–303, Washington, DC 20580, (202)
326–3100.
By Direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E8–21466 Filed 9–16–08; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–08–08BP]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited 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)
ways to enhance 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Audience Profiling for Carbon
Monoxide Poisoning Prevention
Status—New—National Center for
Environmental Health (NCEH),
Coordinating Center for Environmental
Health and Injury Prevention (CCEHIP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Carbon monoxide (CO) is one of the
leading causes of poison-related deaths
in the United States. The Centers for
Disease Control and Prevention (CDC)
estimates that each year approximately
500 people die of unintentional,
nonfire-related CO exposure, and
another 15,000 individuals visit
emergency rooms for treatment from
exposure to CO gas.
Despite our current knowledge of
scenarios and products that lead to CO
poisoning, questions remain about when
and how individuals use CO-emitting
products, why they engage in certain
risk behaviors, how best to inform them
about the CO poisoning, and how
receptive they are to existing prevention
materials. This study aims to address
these questions through assessing the
basis for current audience knowledge,
attitudes, and practices and, ultimately,
strengthen educational materials about
CO poisoning prevention.
The study will employ the use of
qualitative methods during three phases
of data collection. Phase I will consist
of eight in-person focus groups among
home furnace owners and portable
generator owners (n=64) as well as four
telephone interviews with organizations
that serve populations at risk for CO
poisoning (n=4). Phase II will consist of
analyzing previously collected data on
consumer media usage and preferences.
Phase III will consist of 16 in-person
triad interviews (3 individuals per
interview) with home furnace owners
and portable generator owners (n=48) to
pretest CO poisoning educational
materials.
NCEH will identify individuals for the
focus groups and triad interviews using
recruiting firms that specialize in the
two at-risk populations: 1. home furnace
owners and 2. portable generator
owners. Individuals in these two groups
will be screened over the telephone by
the recruiting firms, and if they meet the
eligibility criteria, will be invited to
participate in the study. At the end of
each focus group and triad interview,
NCEH will ask participants to complete
a brief exit questionnaire on
demographics and media usage.
There is no cost to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Respondents (focus group,
phone interview, and triad participants)
Owners of Gas or Oil Burning
Household Appliances.
Number of
responses per
respondent
Number of
respondents
Instrument type
Average burden
per response
(in hours)
Total burden
(in hours)
Expert .......................................
Focus Group Screener .............
Focus Group .............................
Exit Questionnaire ....................
Triad Screener ..........................
Triad ..........................................
Focus Group Screener .............
Focus Group .............................
Exit Questionnaire ....................
Triad Screener ..........................
Triad ..........................................
Telephone Interview .................
64
32
32
48
24
64
32
32
48
24
4
1
1
1
1
1
1
1
1
1
1
1
10/60
2
10/60
10/60
2
10/60
2
10/60
10/60
2
1
11
64
5
8
48
11
64
5
8
48
4
Total ...................................
...................................................
............................
............................
............................
276
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Owners of Portable Gas Burning Generator.
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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Notices
Dated: September 11, 2008.
Maryam Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–21690 Filed 9–16–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0490]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary
Cosmetic Registration Program
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
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 collection of information associated
with the Voluntary Cosmetic
Registration Program.
DATES: Submit written or electronic
comments on the collection of
information by November 17, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
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‘‘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
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.
Voluntary Cosmetic Registration
Program—21 CFR Part 720 (OMB
Control Number 0910–0030)—Extension
The Federal Food, Drug, and Cosmetic
Act (the act) provides FDA with the
authority to regulate cosmetic products
in the United States. Cosmetic products
that are adulterated under section 601 of
the act (21 U.S.C. 361) or misbranded
under section 602 of the act (21 U.S.C.
362) may not be distributed in interstate
commerce. To assist FDA in carrying
out its responsibility to regulate
cosmetics, the agency has developed the
Voluntary Cosmetic Registration
Program (VCRP). In part 720 (21 CFR
part 720), FDA requests that firms that
manufacture, pack, or distribute
cosmetics file with the agency an
ingredient statement for each of their
products. Ingredient statements for new
submissions (§§ 720.1 through 720.4)
are reported on Form FDA 2512,
‘‘Cosmetic Product Ingredient
Statement,’’ and on Form FDA 2512a, a
continuation form. Amendments to
product formulations (§§ 720.3, 720.4,
and 720.6) also are reported on Forms
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53877
FDA 2512 and FDA 2512a. When a firm
discontinues the commercial
distribution of a cosmetic, FDA requests
that the firm file Form FDA 2514,
‘‘Discontinuance of Commercial
Distribution of Cosmetic Product
Formulation’’ (§§ 720.3 and 720.6). If
any of the information submitted on or
with these forms is confidential, the
firm may submit a request for
confidentiality under § 720.8.
FDA’s online filing system, intended
to make it easier to participate in the
VCRP, was made available industrywide on December 1, 2005. The online
filing system is available on FDA’s
VCRP Web site at https://
www.cfsan.fda.gov/~dms/cosregn.html. The online filing system
contains the electronic versions of
Forms FDA 2512, 2512a, and 2514,
which are collectively found within the
electronic version of Form FDA 2512.
The agency strongly encourages
electronic filing of Form FDA 2512
because it is faster and more convenient.
A filing facility will receive
confirmation of electronic filing by email. Submission of the paper version of
Forms FDA 2512, 2512a, and 2514
remains an option as described in
https://www.cfsan.fda.gov/~dms/cosreg2.html. However, due to the high
volume of online participation, the
VCRP is allocating its limited resources
primarily to electronic filings.
FDA places cosmetic product filing
information in a computer data base and
uses the information for evaluation of
cosmetic products currently on the
market. Because filing of cosmetic
product formulations is not mandatory,
voluntary filings provide FDA with the
best information available about
cosmetic product ingredients and their
frequency of use, businesses engaged in
the manufacture and distribution of
cosmetics, and approximate rates of
product discontinuance and formula
modifications. The information assists
FDA scientists in evaluating reports of
alleged injuries and adverse reactions
from the use of cosmetics. The
information also is used in defining and
planning analytical and toxicological
studies pertaining to cosmetics.
Information from the database is
releasable to the public under FDA
compliance with the Freedom of
Information Act. FDA shares
nonconfidential information from its
files on cosmetics with consumers,
medical professionals, and industry.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[Federal Register Volume 73, Number 181 (Wednesday, September 17, 2008)]
[Notices]
[Pages 53876-53877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21690]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-08-08BP]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Maryam Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited 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) ways to enhance 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. Written comments should be received
within 60 days of this notice.
Proposed Project
Audience Profiling for Carbon Monoxide Poisoning Prevention
Status--New--National Center for Environmental Health (NCEH),
Coordinating Center for Environmental Health and Injury Prevention
(CCEHIP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Carbon monoxide (CO) is one of the leading causes of poison-related
deaths in the United States. The Centers for Disease Control and
Prevention (CDC) estimates that each year approximately 500 people die
of unintentional, nonfire-related CO exposure, and another 15,000
individuals visit emergency rooms for treatment from exposure to CO
gas.
Despite our current knowledge of scenarios and products that lead
to CO poisoning, questions remain about when and how individuals use
CO-emitting products, why they engage in certain risk behaviors, how
best to inform them about the CO poisoning, and how receptive they are
to existing prevention materials. This study aims to address these
questions through assessing the basis for current audience knowledge,
attitudes, and practices and, ultimately, strengthen educational
materials about CO poisoning prevention.
The study will employ the use of qualitative methods during three
phases of data collection. Phase I will consist of eight in-person
focus groups among home furnace owners and portable generator owners
(n=64) as well as four telephone interviews with organizations that
serve populations at risk for CO poisoning (n=4). Phase II will consist
of analyzing previously collected data on consumer media usage and
preferences. Phase III will consist of 16 in-person triad interviews (3
individuals per interview) with home furnace owners and portable
generator owners (n=48) to pretest CO poisoning educational materials.
NCEH will identify individuals for the focus groups and triad
interviews using recruiting firms that specialize in the two at-risk
populations: 1. home furnace owners and 2. portable generator owners.
Individuals in these two groups will be screened over the telephone by
the recruiting firms, and if they meet the eligibility criteria, will
be invited to participate in the study. At the end of each focus group
and triad interview, NCEH will ask participants to complete a brief
exit questionnaire on demographics and media usage.
There is no cost to respondents other than their time.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents (focus group, phone interview, Instrument type Number of responses per per response Total burden
and triad participants) respondents respondent (in hours) (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Owners of Gas or Oil Burning Household Focus Group Screener............... 64 1 10/60 11
Appliances. Focus Group........................ 32 1 2 64
Exit Questionnaire................. 32 1 10/60 5
Triad Screener..................... 48 1 10/60 8
Triad.............................. 24 1 2 48
Owners of Portable Gas Burning Generator... Focus Group Screener............... 64 1 10/60 11
Focus Group........................ 32 1 2 64
Exit Questionnaire................. 32 1 10/60 5
Triad Screener..................... 48 1 10/60 8
Triad.............................. 24 1 2 48
Expert..................................... Telephone Interview................ 4 1 1 4
------------------------------------------------------------------------------------------------------------
Total.................................. ................................... ................ ................ ................ 276
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53877]]
Dated: September 11, 2008.
Maryam Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-21690 Filed 9-16-08; 8:45 am]
BILLING CODE 4163-18-P
