Agency Information Collection Activities; Proposed Collection; Comment Request; Submission for Office of Management and Budget Review; Health and Diet Survey; Pet Food Labeling Survey, 23466-23467 [E8-9373]
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Federal Register / Vol. 73, No. 84 / Wednesday, April 30, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines which
have been promulgated by the Department of
Health and Human Services (HHS) as a final
rule, advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule, advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program, and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC).
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to the
CDC. NIOSH implements this responsibility
for CDC. The charter was issued on August
3, 2001, renewed at appropriate intervals,
most recently, August 3, 2007, and will
expire on August 3, 2009.
Purpose: This Advisory Board is charged
with (a) providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class.
Matters to be Discussed: The agenda for the
conference call includes: Special Exposure
Cohort (SEC) Petition Status Updates; Work
Group Updates; Discussion of surrogate data
criteria from work group; Description of
streamlining report from Board’s contractor;
and Status of transcripts and minutes.
The agenda is subject to change as
priorities dictate.
Because there is not a public comment
period, written comments may be submitted.
Any written comments received will be
included in the official record of the meeting
and should be submitted to the contact
person below well in advance of the meeting.
Contact Person for More Information:
Christine M. Branche, PhD, Executive
Secretary, NIOSH, CDC, 395 E Street, SW.,
Suite 9200, Washington, DC 20201,
Telephone (513) 533–6800, Toll Free 1–800–
CDC–INFO, E-mail ocas@cdc.gov.
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pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 21, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–9463 Filed 4–29–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0249]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Submission for
Office of Management and Budget
Review; Health and Diet Survey; Pet
Food Labeling Survey
AGENCY:
Food and Drug Administration,
HHS.
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 for public comment in
response to the notice. This notice
solicits comments on FDA’s Pet Food
Labeling Survey.
DATES: Submit written or electronic
comments on the collection of
information by [May 30, 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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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
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 notice in the
Federal Register concerning each
proposed collection of information
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Sfmt 4703
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.
Health and Diet Survey; Pet Food
Labeling Survey—(OMB Control
Number 0910–0545)
On September 28, 2007, President
Bush signed into law the Food and Drug
Administration Amendments Act of
2007 (FDAAA). Section 1002(a) of
FDAAA requires, among other things,
that FDA establish ‘‘by regulation,’’
standards for labeling of pet food,
including nutritional and ingredient
information. The Center for Veterinary
Medicine (CVM), FDA, seeks to
establish baseline information about
consumer use and understanding of pet
food labels. The survey module would
be repeated after the new pet food label
regulations are implemented to estimate
changes in consumer beliefs and
behavior about pet food labels.
FDA is required to implement the pet
food labeling regulations by September
2009. Due to the short time frame, CVM
seeks to have adequate time to collect
the data to inform future research on
standardized pet food labels. The Center
for Food Safety and Applied Nutrition’s
(CFSAN) Health and Diet Survey (HDS)
(0910–0545) could serve as a vehicle for
accomplishing this goal. CVM and
CFSAN would like to modify the
existing information collection request,
currently at OMB for renewal, to
include a new module.
The proposed plan is to sample a
subset of those responding to the HDS
that are also pet owners. We estimate
that about 14 questions will be asked to
approximately 1,000 respondents. CVM
does not believe that there will be an
additional burden because consumers
would be asked the questions about pet
food labels in lieu of other questions
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Federal Register / Vol. 73, No. 84 / Wednesday, April 30, 2008 / Notices
currently in the HDS. FDA believes that
adding the pet food labeling questions
to the HDS is the most cost effective
way of collecting this information and
precludes the need for a separate pet
food labeling survey, thus reducing the
overall burden to the public.
23467
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Statutory Authority
Public Law 110–85
Sec. 1002(a)(3)
1 There
1,000
Dated: April 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9373 Filed 4–29–08; 8:45 am]
Hours per
Response
1,000
[Docket No. FDA–2008–N–0088] (formerly
Docket No. 2008N–0016)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Additional Listing
Information for Medical Device
Registration and Listing
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 30,
2008.
17:09 Apr 29, 2008
Jkt 214001
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
Additional Listing Information for
Medical Device Registration and
Listing—(OMB Control Number 0910–
0387)—Extension
Food and Drug Administration
VerDate Aug<31>2005
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0387. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rwilkins on PROD1PC63 with NOTICES
1
SUPPLEMENTARY INFORMATION:
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ACTION:
Total Annual
Responses
Total Hours
0.08
80
are no capital costs or operating and maintenance costs associated with this collection of information.
This burden estimate does not
represent a new estimate of burden
hours. Instead, it represents the
estimated number of respondents and
burden hours that will be used from the
current approval for 0910–0545 to
conduct the pet food labeling questions.
The total estimated burden for 0910–
0545 is 1,300 hours. Please note that on
January 15, 2008, the FDA Division of
Dockets Management Web site
transitioned to the Federal Dockets
Management System (FDMS). FDMS is
a Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
AGENCY:
Annual Frequency
per Response
The Food and Drug Administration
Amendments Act of 2007 (the 2007
Amendments), enacted September 27,
2007, requires that device establishment
registrations and listings under 21
U.S.C. 360(p) (including the submission
of updated information), be submitted to
the Secretary of Health and Human
Services (the Secretary) by electronic
means, unless the Secretary grants a
request for waiver of the requirement
because the use of electronic means is
not reasonable for the person requesting
the waiver. See section 224 of the 2007
Amendments. The 2007 Amendments
provides for an October 1, 2007,
effective date. FDA expects 20,000 to
30,000 establishments will need to
register between now and December 31,
2008. FDA is seeking OMB approval for
the information collected by electronic
means. Registration by electronic means
for device establishments will mean
replacement of FDA Forms 2891 and
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2891a, ‘‘Registration of Device
Establishment’’ and FDA Form 2892
‘‘Medical Device Listing,’’ with
electronic versions. However, for OMB
approval of the extension request for
this collection of information, FDA is
revising the scope to address only the
reporting and recordkeeping
requirements by non-electronic means
as described in this document and set
forth in § 807.31 (21 CFR 807.31) for
‘‘Additional Listing Information.’’ To
reflect the revised scope of this
collection of information, FDA has
modified the title.
Under § 807.31(a) through (d), each
owner or operator is required to
maintain an historical file containing
the labeling and advertisements in use
on the date of initial listing, and in use
after October 10, 1978, but before the
date of initial listing. The owner or
operator must maintain in the historical
file any labeling or advertisements in
which a material change has been made
anytime after initial listing, but may
discard labeling and advertisements
from the file 3 years after the date of the
last shipment of a discontinued device
by an owner or operator. Along with the
recordkeeping requirements, under
§ 807.31(e), the owner or operator must
be prepared to submit to FDA copies of:
(1) All device labeling, (2) all device
labeling and representative advertising,
or (3) only representative package
inserts, depending upon whether the
device is subject to the regulatory
controls under section 514 or section
515 of Federal Food, Drug, and
Cosmetic Act (the act), or restrictions
imposed by 21 CFR 801.109 or
otherwise by section 520(e) of the act.
The information collected under these
provisions is used by FDA to identify:
(1) Firms subject to FDA’s regulations,
(2) geographic distribution in order to
effectively allocate FDA’s field
resources for these inspections, and (3)
the class of the device that determines
the frequency of inspection. As a result,
when complications occur with a
particular device or component, all
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]]>Agencies
[Federal Register Volume 73, Number 84 (Wednesday, April 30, 2008)]
[Notices]
[Pages 23466-23467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9373]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0249]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Submission for Office of Management and Budget Review;
Health and Diet Survey; Pet Food Labeling Survey
AGENCY: Food and Drug Administration, HHS.
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 for
public comment in response to the notice. This notice solicits comments
on FDA's Pet Food Labeling Survey.
DATES: Submit written or electronic comments on the collection of
information by [May 30, 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 the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 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 notice in the Federal Register
concerning each proposed 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.
Health and Diet Survey; Pet Food Labeling Survey--(OMB Control Number
0910-0545)
On September 28, 2007, President Bush signed into law the Food and
Drug Administration Amendments Act of 2007 (FDAAA). Section 1002(a) of
FDAAA requires, among other things, that FDA establish ``by
regulation,'' standards for labeling of pet food, including nutritional
and ingredient information. The Center for Veterinary Medicine (CVM),
FDA, seeks to establish baseline information about consumer use and
understanding of pet food labels. The survey module would be repeated
after the new pet food label regulations are implemented to estimate
changes in consumer beliefs and behavior about pet food labels.
FDA is required to implement the pet food labeling regulations by
September 2009. Due to the short time frame, CVM seeks to have adequate
time to collect the data to inform future research on standardized pet
food labels. The Center for Food Safety and Applied Nutrition's (CFSAN)
Health and Diet Survey (HDS) (0910-0545) could serve as a vehicle for
accomplishing this goal. CVM and CFSAN would like to modify the
existing information collection request, currently at OMB for renewal,
to include a new module.
The proposed plan is to sample a subset of those responding to the
HDS that are also pet owners. We estimate that about 14 questions will
be asked to approximately 1,000 respondents. CVM does not believe that
there will be an additional burden because consumers would be asked the
questions about pet food labels in lieu of other questions
[[Page 23467]]
currently in the HDS. FDA believes that adding the pet food labeling
questions to the HDS is the most cost effective way of collecting this
information and precludes the need for a separate pet food labeling
survey, thus reducing the overall burden to the public.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Statutory No. of Annual Frequency Total Annual Hours per
Authority Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Public Law 110-85 1,000 1 1,000 0.08 80
Sec. 1002(a)(3)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
This burden estimate does not represent a new estimate of burden
hours. Instead, it represents the estimated number of respondents and
burden hours that will be used from the current approval for 0910-0545
to conduct the pet food labeling questions. The total estimated burden
for 0910-0545 is 1,300 hours. Please note that on January 15, 2008, the
FDA Division of Dockets Management Web site transitioned to the Federal
Dockets Management System (FDMS). FDMS is a Government-wide, electronic
docket management system. Electronic comments or submissions will be
accepted by FDA only through FDMS at https://www.regulations.gov.
Dated: April 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9373 Filed 4-29-08; 8:45 am]
BILLING CODE 4160-01-S
