Temporary Deferment of Activities Relating to Medical Device Submissions, 23874 [E9-11840]
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Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Notices
relationships that provide young people,
who have an incarcerated parent with
caring adult volunteers.
Additional information about this
program and its purpose can be located
on the following Web site: https://
www.acf.hhs.gov/programs/fysb.
Contact for Further Information:
Gloria Watkins, Family Youth and
Services Bureau, 1250 Maryland Ave.,
SW., Washington, DC 20047. Telephone:
(202) 205–9546. E-mail:
Gloria.Watkins@acf.hhs.gov.
Dated: May 12, 2009.
Maiso L. Bryant,
Acting Commissioner, Administration on
Children, Youth and Families.
[FR Doc. E9–11816 Filed 5–20–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0210]
Temporary Deferment of Activities
Relating to Medical Device
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that the Center for Devices and
Radiological Health (CDRH) will be
moving from various Rockville,
Maryland locations to Building 66 at
10903 New Hampshire Avenue in Silver
Spring, Maryland from approximately
mid May 2009 until the beginning of
August 2009. Offices will progressively
move over weekends during this period.
Specifically, moves will occur on
Friday, Saturday, and Sunday except on
holiday weekends. During the period
required for relocation of files,
equipment, and agency personnel, the
Center for Devices and Radiological
Health will not officially receive
premarket submissions on the Friday of
a move weekend and the Monday after
a move weekend.
FOR FURTHER INFORMATION CONTACT:
Marjorie Shulman, Center for Devices
and Radiological Health (HFZ–404),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4186 or
Marjorie.shulman@fda.hhs.gov.
dwashington3 on PROD1PC60 with NOTICES
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
CDRH is responsible for activities
under sections 510, 513, 515, and 520 of
VerDate Nov<24>2008
13:08 May 20, 2009
Jkt 217001
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360, 360c, 360e,
and 360j). These activities include, but
are not limited to:
1. Advising the Director, CDRH, and
other FDA officials on all medical
device submissions, such as premarket
notification submissions under section
510(k) of the act, device classifications
under section 513 of the act, premarket
approval applications (PMA’s) and
product development protocols (PDP’s)
under section 515 of the act, and
clinical investigations under section 520
of the act;
2. Determining substantial
equivalence for premarket notification
submissions;
3. Planning, conducting, and
coordinating CDRH actions regarding
PMA’s, PDP’s, and investigational
device exemption approvals, denials, or
withdrawals of approval;
4. Monitoring sponsors’ compliance
with regulatory requirements; and
5. Conducting a continuing review,
surveillance, and medical evaluation of
the labeling, clinical experience, and
required reports submitted by sponsors
holding approved applications.
In an effort to consolidate CDRH
offices, FDA is moving various CDRH
offices from their present Rockville,
Maryland locations to Building 66 at
10903 New Hampshire Avenue in Silver
Spring, Maryland. Offices will
progressively move, during weekends,
during this period. Specifically, moves
will occur on Friday, Saturday, and
Sunday except on holiday weekends.
During the period required for
relocation of files, equipment, and
agency personnel, the agency,
specifically the Center for Devices and
Radiological Health, will not officially
receive submissions on the Friday of a
move weekend and the Monday after a
move weekend. Although mail will be
delivered to a CDRH address during the
move, CDRH will not be able to receive
it on Fridays and Mondays, and will
have limited capacity on Tuesday.
Accordingly, mail delivered on Friday
or Monday will be logged in on a
staggered basis to preserve equity in the
order of receipt and manageability of the
accumulated workload. Specifically,
mail delivered on Friday or Monday
will be received on Tuesday and mail
delivered on Tuesday will be received
by Wednesday. Mail delivered on
Wednesdays and Thursdays will remain
unaffected.
The new mailing address for
submissions and updated telephone
contact information may be found by
accessing www.fda.gov/cdrh/
whiteoakmove.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
II. Comments
Persons who may be affected by this
temporary deferment should contact
FDA with any questions they may have
regarding CDRH’s move to the White
Oak, Maryland. These persons should
call CDRH’s Division of Small
Manufacturers, International, and
Consumer Assistance at 800–638–2041
(in Maryland, 240–276–3150).
Dated: May 13, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E9–11840 Filed 5–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Accreditation and Approval of Intertek
USA, Inc., as a Commercial Gauger
and Laboratory
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of Intertek USA, Inc., as a
commercial gauger and laboratory.
SUMMARY: Notice is hereby given that,
pursuant to 19 CFR 151.12 and 19 CFR
151.13, Intertek USA, Inc., 101 20th
Street South, Texas City, TX 77590, has
been approved to gauge and accredited
to test petroleum and petroleum
products, organic chemicals and
vegetable oils for customs purposes, in
accordance with the provisions of 19
CFR 151.12 and 19 CFR 151.13. Anyone
wishing to employ this entity to conduct
laboratory analyses and gauger services
should request and receive written
assurances from the entity that it is
accredited or approved by the U.S.
Customs and Border Protection to
conduct the specific test or gauger
service requested. Alternatively,
inquires regarding the specific test or
gauger service this entity is accredited
or approved to perform may be directed
to the U.S. Customs and Border
Protection by calling (202) 344–1060.
The inquiry may also be sent to
cbp.labhq@dhs.gov. Please reference the
Web site listed below for a complete
listing of CBP approved gaugers and
accredited laboratories.https://cbp.gov/
xp/cgov/import/operations_support/
labs_scientific_svcs/
commercial_gaugers/.
DATES: The accreditation and approval
of Intertek USA, Inc., as commercial
gauger and laboratory became effective
E:\FR\FM\21MYN1.SGM
21MYN1
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[Federal Register Volume 74, Number 97 (Thursday, May 21, 2009)]
[Notices]
[Page 23874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11840]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0210]
Temporary Deferment of Activities Relating to Medical Device
Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that the
Center for Devices and Radiological Health (CDRH) will be moving from
various Rockville, Maryland locations to Building 66 at 10903 New
Hampshire Avenue in Silver Spring, Maryland from approximately mid May
2009 until the beginning of August 2009. Offices will progressively
move over weekends during this period. Specifically, moves will occur
on Friday, Saturday, and Sunday except on holiday weekends. During the
period required for relocation of files, equipment, and agency
personnel, the Center for Devices and Radiological Health will not
officially receive premarket submissions on the Friday of a move
weekend and the Monday after a move weekend.
FOR FURTHER INFORMATION CONTACT: Marjorie Shulman, Center for Devices
and Radiological Health (HFZ-404), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4186 or
Marjorie.shulman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH is responsible for activities under sections 510, 513, 515,
and 520 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360, 360c, 360e, and 360j). These activities include, but are
not limited to:
1. Advising the Director, CDRH, and other FDA officials on all
medical device submissions, such as premarket notification submissions
under section 510(k) of the act, device classifications under section
513 of the act, premarket approval applications (PMA's) and product
development protocols (PDP's) under section 515 of the act, and
clinical investigations under section 520 of the act;
2. Determining substantial equivalence for premarket notification
submissions;
3. Planning, conducting, and coordinating CDRH actions regarding
PMA's, PDP's, and investigational device exemption approvals, denials,
or withdrawals of approval;
4. Monitoring sponsors' compliance with regulatory requirements;
and
5. Conducting a continuing review, surveillance, and medical
evaluation of the labeling, clinical experience, and required reports
submitted by sponsors holding approved applications.
In an effort to consolidate CDRH offices, FDA is moving various
CDRH offices from their present Rockville, Maryland locations to
Building 66 at 10903 New Hampshire Avenue in Silver Spring, Maryland.
Offices will progressively move, during weekends, during this period.
Specifically, moves will occur on Friday, Saturday, and Sunday except
on holiday weekends. During the period required for relocation of
files, equipment, and agency personnel, the agency, specifically the
Center for Devices and Radiological Health, will not officially receive
submissions on the Friday of a move weekend and the Monday after a move
weekend. Although mail will be delivered to a CDRH address during the
move, CDRH will not be able to receive it on Fridays and Mondays, and
will have limited capacity on Tuesday. Accordingly, mail delivered on
Friday or Monday will be logged in on a staggered basis to preserve
equity in the order of receipt and manageability of the accumulated
workload. Specifically, mail delivered on Friday or Monday will be
received on Tuesday and mail delivered on Tuesday will be received by
Wednesday. Mail delivered on Wednesdays and Thursdays will remain
unaffected.
The new mailing address for submissions and updated telephone
contact information may be found by accessing www.fda.gov/cdrh/whiteoakmove.
II. Comments
Persons who may be affected by this temporary deferment should
contact FDA with any questions they may have regarding CDRH's move to
the White Oak, Maryland. These persons should call CDRH's Division of
Small Manufacturers, International, and Consumer Assistance at 800-638-
2041 (in Maryland, 240-276-3150).
Dated: May 13, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-11840 Filed 5-20-09; 8:45 am]
BILLING CODE 4160-01-S