Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability, 69160-69161 [05-22500]
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69160
Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–22610 Filed 11–10–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D–0554]
Revised Compliance Policy Guide
Regarding Prior Notice of Imported
Food Under the Public Health Security
and Bioterrorism Preparedness and
Response Act of 2002; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a revised compliance
policy guide (CPG) Sec. 110.310 entitled
‘‘Prior Notice of Imported Food Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002.’’ The CPG
provides written guidance to FDA’s and
Customs and Border Protection’s (CBP’s)
staff on enforcement of section 307 of
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) and the agency’s implementing
regulations, which require prior notice
for food imported or offered for import
into the United States. The CPG has
been revised to finalize the sections
pertaining to routine shipments of food
that are transshipped through the
United States, arriving from and exiting
to the same country, and regarding the
Harmonized Tariff Schedule (HTS) code
that is part of the planned shipment
information.
The revised CPG is final upon
the date of publication. However, you
DATES:
VerDate Aug<31>2005
17:16 Nov 10, 2005
Jkt 208001
may submit written or electronic
comments on the revised CPG at any
time.
You may submit comments,
identified by Docket No. 2003D–0544
and/ Regulatory Information Number
(RIN) number (if a RIN number has been
assigned), by any of the following
methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described in the
Electronic Submissions portion of this
paragraph.
Instructions: All submissions received
must include the agency name and
Docket No(s). and RIN (if a RIN number
has been assigned) for this rulemaking.
All comments received may be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
number(s), found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the revised guidance to the
Division of Compliance Policy (HFC–
230), Office of Enforcement, Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
that office in processing your request or
ADDRESSES:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
include a fax number to which the
guidance may be sent.
FOR FURTHER INFORMATION CONTACT:
Laura Draski, Office of Regulatory
Affairs (HFC–180), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 866–521–2297.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 4,
2005 (70 FR 10657), FDA announced the
availability of a draft revision to CPG
Sec. 110.310 entitled ‘‘Prior Notice of
Imported Food Under the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002.’’ This revised
guidance was issued with CBP
concurrence and explains to FDA and
CBP staff the new FDA and CBP policies
on enforcement of section 307 of the
Bioterrorism Act and its implementing
regulations, which require prior notice
to FDA of all food imported or offered
for import into the United States (21
CFR parts 1.276 through 1.285). The
new policies provide additional
flexibility in filing prior notice when,
due to the geography, the only practical
transportation route available for the
shipment is through the United States
and when there is a prior notice
violation because the prior notice does
not include the 6-digit HTS code for the
article of food.
FDA received 8 comments on the
draft sections of the revised CPG. FDA
reviewed and evaluated these comments
and has modified the CPG with CBP
concurrence, where appropriate.
FDA is issuing this CPG as level 1
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The CPG represents the
agency’s current thinking on its
enforcement policy concerning prior
notice. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance document.
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 revised
CPG and received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
E:\FR\FM\14NON1.SGM
14NON1
69161
Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices
Choke Cherry Road, Room 3–1017,
Rockville, Maryland 20857, telephone
(240) 276–1124 (not a toll-free number).
III. Electronic Access
An electronic version of the revised
CPG is available on the Internet at
https://www.fda.gov/ora under
‘‘Compliance References.’’
Dated: November 4, 2005.
Steve Niedelman,
Acting Associate Commissioner for
Regulatory Affairs.
[FR Doc. 05–22500 Filed 11–10–05; 8:45 am]
Dated: November 8, 2005.
Charles G. Curier,
Administrator, SAMHSA.
[FR Doc. 05–22538 Filed 11–10–05; 8:45 am]
BILLING CODE 4160–01–M
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FR–4971–N–58]
Notice of Submission of Proposed
Information Collection to OMB;
Procedures for Appealing Section 8
Rent Adjustments
Public Health Services; Notice of
Listing of Members of the Substance
Abuse and Mental Health Services
Administration’s Senior Executive
Service Performance Review Board
(PRB)
Office of the Chief Information
Officer, HUD.
ACTION: Notice.
AGENCY:
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) announces the persons who
will serve on the Substance Abuse and
Mental Health Services
Administration’s Performance Review
Board. This action is being taken in
accordance with Title 5, U.S.C., Section
4314(c)(4), which requires that members
of performance review boards be
appointed in a manner to ensure
consistency, stability, and objectivity in
performance appraisals, and requires
that notice of the appointment of an
individual to serve as a member be
published in the Federal Register.
The following persons will serve on
the SAMHSA Performance Review
Board, which oversees the evaluation of
performance appraisals of SAMHSA’s
Senior Executive Service (SES)
members:
Andrew C. Knapp, Chairperson,
Eric Broderick,
Curt Coy,
Daryl W. Kade.
For further information about the
SAMHSA Performance Review Board,
contact the Division of Management
Systems, Substance Abuse and Mental
Health Services Administration, 1
This
notice informs the public that the
Department of Housing and Urban
Development has submitted to OMB a
request for approval of the information
collection described below. This notice
is soliciting comments from members of
the public and affected agencies
concerning the proposed collection of
information to: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (3) Enhance the quality,
utility, and clarity of the information to
be collected; and (4) Minimize the
burden of the collection of information
on those who are to respond; including
through the use of appropriate
automated collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
Substance Abuse and Mental Health
Services Administration
Street, SW., Washington, DC 20410; email Wayne_Eddins@HUD.gov; or
Lillian Deitzer at
Lillian_L_Deitzer@HUD.gov or
telephone (202) 708–2374. This is not a
toll-free number. Copies of available
documents submitted to OMB may be
obtained from Mr. Eddins or Ms.
Deitzer.
SUMMARY: The proposed information
collection requirement described below
has been submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
When a rent increase for certain
Section 8 subsidized projects is denied,
in full or in part, owners may submit to
HUD an appeal letter outlining the basis
for the appeal. The appeal letter must be
submitted to the Contract Administrator
or the HUD Director for review. HUD
uses the information to determine
whether to deny or allow Section 8 rent
increases.
DATES: Comments Due Date: December
14, 2005.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
approval Number (2502–0446) and
should be sent to: HUD Desk Officer,
Office of Management and Budget, New
Executive Office Building, Washington,
DC 20503; fax: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Wayne Eddins, Reports Management
Officer, AYO, Department of Housing
and Urban Development, 451 Seventh
This Notice Also Lists the Following
Information
Title of Proposal: Procedures for
Appealing Section 8 Rent Adjustments.
OMB Approval Number: 2502–0446.
Form Numbers: None.
Description of the Need for the
Information and Its Proposed Use:
When a rent increase for certain Section
8 subsidized projects is denied, in full
or in part, owners may submit to HUD
an appeal letter outlining the basis for
the appeal. The appeal letter must be
submitted to the Contract Administrator
or the HUD Director for review HUD
uses the information to determine
whether to deny or allow Section 8 rent
increases.
Frequency of Submission: On
occasion.
Number of
respondents
Reporting burden .......................................................................................................
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17:16 Nov 10, 2005
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Annual
responses
500
1
E:\FR\FM\14NON1.SGM
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×
Hours per
response
2
= Burden
hours
1,000
]]>Agencies
[Federal Register Volume 70, Number 218 (Monday, November 14, 2005)]
[Notices]
[Pages 69160-69161]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22500]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0554]
Revised Compliance Policy Guide Regarding Prior Notice of
Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised compliance policy guide (CPG) Sec. 110.310
entitled ``Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.'' The
CPG provides written guidance to FDA's and Customs and Border
Protection's (CBP's) staff on enforcement of section 307 of the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(the Bioterrorism Act) and the agency's implementing regulations, which
require prior notice for food imported or offered for import into the
United States. The CPG has been revised to finalize the sections
pertaining to routine shipments of food that are transshipped through
the United States, arriving from and exiting to the same country, and
regarding the Harmonized Tariff Schedule (HTS) code that is part of the
planned shipment information.
DATES: The revised CPG is final upon the date of publication. However,
you may submit written or electronic comments on the revised CPG at any
time.
ADDRESSES: You may submit comments, identified by Docket No. 2003D-0544
and/ Regulatory Information Number (RIN) number (if a RIN number has
been assigned), by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). and RIN (if a RIN number has been assigned) for this
rulemaking. All comments received may be posted without change to
https://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Submit written requests for single copies of the revised guidance
to the Division of Compliance Policy (HFC-230), Office of Enforcement,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your request or include a fax number to which the guidance
may be sent.
FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory
Affairs (HFC-180), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 866-521-2297.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 4, 2005 (70 FR 10657), FDA
announced the availability of a draft revision to CPG Sec. 110.310
entitled ``Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.'' This
revised guidance was issued with CBP concurrence and explains to FDA
and CBP staff the new FDA and CBP policies on enforcement of section
307 of the Bioterrorism Act and its implementing regulations, which
require prior notice to FDA of all food imported or offered for import
into the United States (21 CFR parts 1.276 through 1.285). The new
policies provide additional flexibility in filing prior notice when,
due to the geography, the only practical transportation route available
for the shipment is through the United States and when there is a prior
notice violation because the prior notice does not include the 6-digit
HTS code for the article of food.
FDA received 8 comments on the draft sections of the revised CPG.
FDA reviewed and evaluated these comments and has modified the CPG with
CBP concurrence, where appropriate.
FDA is issuing this CPG as level 1 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The CPG represents
the agency's current thinking on its enforcement policy concerning
prior notice. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance
document. 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 revised CPG and
received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 69161]]
III. Electronic Access
An electronic version of the revised CPG is available on the
Internet at https://www.fda.gov/ora under ``Compliance References.''
Dated: November 4, 2005.
Steve Niedelman,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 05-22500 Filed 11-10-05; 8:45 am]
BILLING CODE 4160-01-S
