Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation, 65904-65905 [05-21774]
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Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of respondents
Number of responses per
respondent
Average burden hours per
response
Child Welfare Agency Workers ........................................................................
120
1
2
240
Total ..........................................................................................................
........................
........................
........................
656
Instrument
Estimated Total Annual Burden
Hours: 656.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. e-mail address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: October 28, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–21674 Filed 10–31–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0426]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notice of
Participation
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
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15:39 Oct 31, 2005
Jkt 208001
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
reporting requirements for filing a
notice of participation with FDA.
Submit written or electronic
comments on the collection of
information by January 3, 2006.
DATES:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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 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.
SUPPLEMENTARY INFORMATION:
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Total burden
hours
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 Participation—21 CFR 12.45
(OMB Control Number 0910–0191)—
Extension
Section 12.45 (21 CFR 12.45) issued
under section 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371),
sets forth the format and procedures for
any interested person to file a petition
to participate in a formal evidentiary
hearing, either personally or through a
representative. Section 12.45 requires
that any person filing a notice of
participation, state their specific interest
in the proceedings, including the
specific issues of fact about which the
person desires to be heard. This section
also requires that the notice include a
statement that the person will present
testimony at the hearing and will
comply with specific requirements in
§ 12.85. Or, in the case of a hearing
before a Public Board of Inquiry (21 CFR
13.25), concerning disclosure of data
and information by participants. In
accordance with § 12.45(e) the presiding
officer may omit a participant’s
appearance.
The presiding officer and other
participants will use the collected
information in a hearing to identify
specific interests to be presented. This
preliminary information serves to
expedite the prehearing conference and
commits participation.
The respondents are individuals or
households, State or local governments,
not for profit institutions, and
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Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices
businesses, or other for profit groups
and institutions.
21 CFR Section
FDA estimates the burden of this
collection of information as follows:
No. of Respondents
12.45
264
1 There
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0412]
Guidance for Industry: A Notice from
the Food and Drug Administration to
Growers, Food Manufacturers, Food
Warehouse Managers, and
Transporters of Food Products on
Decontamination of Transport
Vehicles; Availability
AGENCY:
Total Annual Responses
1
Hours per Response
264
Total Hours
3
792
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21774 Filed 10–31–05; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
Annual Frequency
per Response
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘A Notice from the Food and
Drug Administration to Growers, Food
Manufacturers, Food Warehouse
Managers, and Transporters of Food
Products on Decontamination of
Transport Vehicles.’’ This guidance is
intended to provide information and
references that can be used for the
decontamination of food transport
vehicles following Hurricanes Katrina
and Rita in August and September 2005.
The scope of this guidance is limited to
decontamination of trucks, rail cars, and
cold storage units that were flooded or
otherwise impacted by the hurricanes,
before being placed back in service to
transport or store food.
DATES: This guidance is final upon the
date of publication. Submit written or
electronic comments on agency
guidances at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Plant Product Safety (HFS–
305), Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20747. Send
one self-addressed adhesive label to
assist that office in processing your
requests or include a fax number to
SUMMARY:
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15:39 Oct 31, 2005
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which the guidance may be sent. Submit
written comments on the guidance 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.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS–
305), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20747, 301–436–2022.
SUPPLEMENTARY INFORMATION:
I. Background
In the aftermath of Hurricanes Katrina
and Rita, the Center for Food Safety and
Applied Nutrition has received
inquiries about how food transport units
such as trucks, rail cars, and cold
storage units that were flooded or
otherwise impacted by the hurricanes
may be decontaminated for return to
service to transport food. FDA is
announcing the availability of a
guidance document that provides
information and references addressing
this subject.
FDA is issuing this document as a
level 1 guidance consistent with FDA’s
good guidance practices regulation
(§ 10.115 (21 CFR 10.115)). The
guidance is being implemented
immediately without prior public
comment, under § 10.115(g)(2), because
the agency has determined that prior
public participation is not feasible or
appropriate.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this guidance.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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III. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
https://www.cfsan.fda.gov/
guidance.html.
Dated: October 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21642 Filed 10–31–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
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.
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[Federal Register Volume 70, Number 210 (Tuesday, November 1, 2005)]
[Notices]
[Pages 65904-65905]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21774]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0426]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Notice of Participation
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,
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 reporting requirements for
filing a notice of participation with FDA.
DATES: Submit written or electronic comments on the collection of
information by January 3, 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: Jonna Capezzuto, Office of Management
Programs (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 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 Participation--21 CFR 12.45 (OMB Control Number 0910-0191)--
Extension
Section 12.45 (21 CFR 12.45) issued under section 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the
format and procedures for any interested person to file a petition to
participate in a formal evidentiary hearing, either personally or
through a representative. Section 12.45 requires that any person filing
a notice of participation, state their specific interest in the
proceedings, including the specific issues of fact about which the
person desires to be heard. This section also requires that the notice
include a statement that the person will present testimony at the
hearing and will comply with specific requirements in Sec. 12.85. Or,
in the case of a hearing before a Public Board of Inquiry (21 CFR
13.25), concerning disclosure of data and information by participants.
In accordance with Sec. 12.45(e) the presiding officer may omit a
participant's appearance.
The presiding officer and other participants will use the collected
information in a hearing to identify specific interests to be
presented. This preliminary information serves to expedite the
prehearing conference and commits participation.
The respondents are individuals or households, State or local
governments, not for profit institutions, and
[[Page 65905]]
businesses, or other for profit groups and institutions.
FDA estimates the burden of this collection of information as
follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency
21 CFR Section No. of Respondents per Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
12.45 264 1 264 3 792
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21774 Filed 10-31-05; 8:45 am]
BILLING CODE 4160-01-S
