Small Entity Compliance Guide on Prior Notice of Imported Food; Availability, 18736-18737 [E9-9358]
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18736
Federal Register / Vol. 74, No. 78 / Friday, April 24, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Part C Early Intervention Services
Grant
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice of Noncompetitive
Replacement Award.
SUMMARY: The Health Resources and
Services Administration (HRSA) is
issuing a non-competitive replacement
award of Part C Early Intervention
Services funds under Title XXVI of the
Public Health Service Act, as amended
by the Ryan White HIV/AIDS Treatment
Modernization Act of 2006, to the
Reading Hospital for services previously
provided by the St. Joseph Medical
Center in order to ensure continuity of
critical HIV medical care and treatment
services and to avoid a disruption of
HIV clinical care to clients in the city of
Reading, Pennsylvania, and all of Berks
and Schuylkill Counties.
SUPPLEMENTARY INFORMATION:
Grantee of Record: St. Joseph Medical
Center.
Intended Recipient of the Award: The
Reading Hospital and Medical Center.
Amount of the Award: $334,051.
population as originally supported
under the award to St. Joseph’s Medical
Center while the service area is recompeted.
This supplement will cover the time
period from March 1, 2009, through
March 31, 2010. This service area will
be included in the upcoming
competition for the Part C HIV Early
Intervention Services (EIS) competing
application process for project periods
starting April 1, 2010.
FOR FURTHER INFORMATION CONTACT:
Maria C. Rios, via e-mail,
mrios@hrsa.gov, or via telephone, 301–
443–0493.
Dated: April 17, 2009.
Marcia K. Brand,
Administrator.
[FR Doc. E9–9382 Filed 4–23–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0187]
Small Entity Compliance Guide on
Prior Notice of Imported Food;
Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
Authority: Section 2651 of the Public
Health Service Act, 42 U.S.C. 300ff–51.
ACTION:
CFDA Number: 93.918.
Project Period: The period of support
for the replacement award is from
March 1, 2009, to March 31, 2010.
Justification for the Exception to
Competition:
Critical funding for HIV medical care
and treatment services to clients in the
city of Reading, as well as Berks and
Schuylkill counties in Pennsylvania,
will be continued through a
noncompetitive replacement award to
the Reading Hospital. This is a
temporary replacement award as the
previous grant recipient serving this
population notified HRSA that it could
not continue providing services after
February 27, 2009, (the original
competitive project period was July 1,
2006, through June 30, 2009). The
Reading Hospital is the best qualified
grantee for this supplement for the
following reasons: It is in the same
locality as former grantee; it currently
provides HIV medical care to many of
the former grantee’s clients; and it has
the capability of providing
comprehensive HIV/AIDS services to
the city of Reading and nearby counties.
The Reading Hospital is able to continue
providing critical services to the service
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a small entity compliance
guide (SECG) for the final rule on prior
notice of imported food. The final rule
issued under the Public Health Security
and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act), and it was published in the
Federal Register of November 7, 2008.
The SECG is entitled ‘‘What You Need
to Know About Prior Notice of Imported
Food Shipments—A Small Entity
Compliance Guide,’’ and it is intended
to help all entities, especially small
businesses, better understand the prior
notice regulation.
DATES: Submit written or electronic
comments on the SECG at any time.
ADDRESSES: Submit written requests for
single copies of the SECG to the CFSAN
Outreach and Information Center, Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 1–
877–366–3322, or email your request to
industry@fda.gov.
Submit written comments concerning
the SECG to the Division of Dockets
VerDate Nov<24>2008
16:20 Apr 23, 2009
Jkt 217001
PO 00000
Notice.
Frm 00054
Fmt 4703
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Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments on the SECG to
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to this SECG.
FOR FURTHER INFORMATION CONTACT:
Laura Draski, Office of Regulatory
Affairs (HFC–100), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 866–521–2297.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November
7, 2008 (73 FR 66294), FDA issued the
prior notice final rule implementing
section 307 of the Bioterrorism Act. The
prior notice final rule requires the
submission to FDA of prior notice of
food, including animal feed, that is
imported or offered for import into the
United States.
FDA examined the economic
implication of this final rule as required
by the Regulatory Flexibility Act (5
U.S.C. 601–612) and determined that it
would have a significant economic
impact on a substantial number of small
entities.
In compliance with section 212 of the
Small Business Regulatory Enforcement
Fairness Act (Public Law 104–121), FDA
is making available this SECG that
explains the requirements of this
regulation.
FDA is issuing this SECG as a level 2
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115(c)(2)). This SECG restates, in
simplified format and language, FDA’s
current requirements for prior notice of
imported food. As guidance, this
document is not binding on either FDA
or the public. FDA notes, however, that
the regulation that serves as the basis for
this guidance document establishes
requirements for all covered activities.
For this reason, FDA strongly
recommends that affected parties
consult the regulations at 21 CFR part 1,
subpart I, in addition to reading this
SECG.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this SECG. 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. Received comments may be
seen in the Division of Dockets
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24APN1
Federal Register / Vol. 74, No. 78 / Friday, April 24, 2009 / Notices
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain this SECG at https://
www.cfsan.fda.gov/guidance.html.
Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9358 Filed 4–23–09; 8:45 am]
BILLING CODE 4160–01–S
FOR FURTHER INFORMATION CONTACT:
Marc Kutnik, 245 Murray Lane, SW.,
Bldg. 410, Washington, DC 20528,
Marc.Kutnik@dhs.gov, 202–282–8336,
fax 202–282–8806.
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2009–0030]
Homeland Security Information
Network Advisory Committee
Committee Management; Notice
of Federal Advisory Committee Meeting.
mstockstill on PROD1PC66 with NOTICES
SUMMARY: The Homeland Security
Information Network Advisory
Committee (HSINAC) will meet from
May 12–May 14, 2009, in Potomac, MD.
The meeting will be open to the public.
DATES: The HSINAC will meet Tuesday,
May 12, 2009, from 8 a.m. to 6 p.m.,
Wednesday, May 13, 2009 from 8 a.m.
to 6 p.m. and on Thursday, May 14,
2009, from 8 a.m. to 1:30 p.m. Please
note that the meeting may close early if
the committee has completed its
business.
ADDRESSES: The meeting will be held at
the Bolger Center, 9600 Newbridge
Drive, Potomac, MD 20854–4436. Send
written material, comments, and
requests to make oral presentations to
Marc Kutnik, Department of Homeland
Security, 245 Murray Lane, SW., Bldg.
410, Washington, DC 20528. Requests to
make oral statements at the meeting
should reach the contact person listed
below by May 05, 2009. Requests to
have a copy of your material distributed
to each member of the committee prior
to the meeting should reach the contact
person at the address below by May 05,
2009. Questions and comments must be
identified by DHS–2009–0030 and may
be submitted by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: Marc.Kutnik@dhs.gov.
Include the docket number, DHS–2009–
0030 in the subject line of the message.
• Fax: 202–282–8806
• Mail: Marc Kutnik, Department of
Homeland Security, 245 Murray Lane,
SW., Building 410, Washington, DC
20528.
16:20 Apr 23, 2009
Jkt 217001
Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C. App.
(Pub. L. 92–463). The mission of the
Homeland Security Information
Network Advisory Committee is to
identify issues and provide independent
advice and recommendations for the
improvement of the Homeland Security
Information Network (HSIN) to senior
leadership of the Department, in
particular the Director of Operations
Coordination and Planning. The agenda
for this meeting will include an update
and discussion on efforts concerning the
improvement of HSIN, discussions on
federal, state, and local information
sharing and portal consolidation, a
briefing and discussion on the HSIN
Mission Operators Committee and
Business Case, and discussions
pertaining to HSIN community best
practices and the HSIN law enforcement
and fire services communities.
SUPPLEMENTARY INFORMATION:
ACTION:
VerDate Nov<24>2008
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number for this action. Comments
received will be posted without
alteration at https://www.regulations.gov,
including any personal information
provided.
Docket: For access to the docket to
read background documents or
comments received by the Homeland
Security Information Network Advisory
Committee, go to https://
www.regulations.gov.
Procedural
This meeting is open to the public.
The chairperson of the Homeland
Security Information Network Advisory
Committee shall conduct the meeting in
a way that will, in his judgment,
facilitate the orderly conduct of
business. Please note that the meeting
may end early if all business is
completed.
Participation in HSINAC deliberations
is limited to committee members and
Department of Homeland Security
officials.
All visitors to Bolger Center will have
to pre-register to be admitted to the
building. Please provide your name,
telephone number by close of business
on May 05, 2009 to Marc Kutnik (202–
282–8336) (Marc.Kutnik@dhs.gov).
Seating may be limited and is available
on a first-come, first-served basis.
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18737
Information on Services for Individuals
With Disabilities
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
meeting, contact Marc Kutnik as soon as
possible.
Dated: April 20, 2009.
Robert Cohen,
Deputy Director of Operations Coordination
and Planning.
[FR Doc. E9–9431 Filed 4–23–09; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–693, Revision of a
Currently Approved Information
Collection; Comment Request
ACTION: 60-Day Notice of Information
Collection Under Review: Form I–693,
Report of Medical Examination and
Vaccination Record, OMB Control No.
1615–0033.
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS), has
submitted the following information
collection request for review and
clearance in accordance with the
Paperwork Reduction Act of 1995. The
information collection is published to
obtain comments from the public and
affected agencies. Comments are
encouraged and will be accepted for
sixty days until June 23, 2009.
Written comments and suggestions
regarding items contained in this notice,
and especially with regard to the
estimated public burden and associated
response time should be directed to the
Department of Homeland Security
(DHS), USCIS, Chief, Regulatory
Products Division, Clearance Office, 111
Massachusetts Avenue, NW.,
Washington, DC 20529–2210.
Comments may also be submitted to
DHS via facsimile to 202–272–8352, or
via e-mail at rfs.regs@dhs.gov. When
submitting comments by e-mail please
add the OMB Control Number 1615–
0033 in the subject box.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information should address one or more
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
E:\FR\FM\24APN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 78 (Friday, April 24, 2009)]
[Notices]
[Pages 18736-18737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0187]
Small Entity Compliance Guide on Prior Notice of Imported Food;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a small entity compliance guide (SECG) for the final
rule on prior notice of imported food. The final rule issued under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act), and it was published in the Federal
Register of November 7, 2008. The SECG is entitled ``What You Need to
Know About Prior Notice of Imported Food Shipments--A Small Entity
Compliance Guide,'' and it is intended to help all entities, especially
small businesses, better understand the prior notice regulation.
DATES: Submit written or electronic comments on the SECG at any time.
ADDRESSES: Submit written requests for single copies of the SECG to the
CFSAN Outreach and Information Center, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 1-877-366-3322, or email your request
to industry@fda.gov.
Submit written comments concerning the SECG to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
on the SECG to https://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to this SECG.
FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory
Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 866-521-2297.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 7, 2008 (73 FR 66294), FDA
issued the prior notice final rule implementing section 307 of the
Bioterrorism Act. The prior notice final rule requires the submission
to FDA of prior notice of food, including animal feed, that is imported
or offered for import into the United States.
FDA examined the economic implication of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and
determined that it would have a significant economic impact on a
substantial number of small entities.
In compliance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Public Law 104-121), FDA is making available
this SECG that explains the requirements of this regulation.
FDA is issuing this SECG as a level 2 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). This
SECG restates, in simplified format and language, FDA's current
requirements for prior notice of imported food. As guidance, this
document is not binding on either FDA or the public. FDA notes,
however, that the regulation that serves as the basis for this guidance
document establishes requirements for all covered activities. For this
reason, FDA strongly recommends that affected parties consult the
regulations at 21 CFR part 1, subpart I, in addition to reading this
SECG.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this SECG.
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. Received comments may be seen in the
Division of Dockets
[[Page 18737]]
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain this SECG at https://www.cfsan.fda.gov/guidance.html.
Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9358 Filed 4-23-09; 8:45 am]
BILLING CODE 4160-01-S
