Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years;” Request for Comments, 45825-45826 [2011-19353]
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Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
As discussed in section V.A.2 of this
document, some requests for removal
from region- or country-wide import
alerts will not lead to the assessment of
a fee. Fees would only be assessed in
situations where, in issuing the alert,
FDA reviewed compliance information
specific to a particular person or entity
sufficiently related to the request for
removal. An example of such a situation
is where FDA analyzed samples of food
from Processor A and found it to be
contaminated, the food is then placed
on a region- or country-wide import
alert, and FDA receives a request to
remove food from Processor A from the
import alert.
3. Entity Requesting Removal From an
Import Alert for Detention Without
Physical Examination.
4. Destruction of Food That Has Been
Refused Admission
C. How much will this fee be?
If a product is refused admission
under section 801(a) of the FD&C Act,
it must be exported within 90 days of
the document of refusal or it is subject
to destruction by CBP (section 801(a) of
the FD&C Act). In practice, when a
product is destroyed, destruction is
often conducted by the owner or
consignee under the supervision of FDA
or CBP. Where FDA conducts a review
and/or approves a destruction proposal
and such supervision of destruction
occurs, FDA considers this to be ‘‘1 or
more examinations conducted under
section 801 * * * specifically to
determine whether compliance has been
achieved’’ to FDA’s satisfaction.
B. Who will be responsible for paying
this fee?
The importer that is subject to the
additional examinations that are
described in section V.A of this
document is responsible for paying the
fee, according to section 743(a)(1)(D) of
the FD&C Act.
1. Reconditioning of Imported Food
srobinson on DSK4SPTVN1PROD with NOTICES
For reconditioning, the entity that is
responsible for the reconditioning is
responsible for paying the fee. The
request for reconditioning can only be
made by the owner or consignee of the
food (21 CFR 1.95). If ownership
changes, the new owner will be
responsible for the reconditioning if that
new owner executes a bond and obtains
a new authorization (21 CFR 1.96(d)).
2. Importer Seeking Admission of an
Article That Has Been Detained
The entity that introduces evidence
regarding admissibility is responsible
for paying this fee. This is the owner or
consignee of the food that is being
imported or offered for import. (Section
801(a) of the FD&C Act; 21 CFR 1.83(b)
and 1.94(a).)
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Jkt 223001
FDA considers the entity that requests
removal of the food from the import
alert to be the importer subject to the
examination and, thus, responsible for
paying this fee.
4. Destruction of Food That Has Been
Refused Admission
FDA considers the entity that destroys
the product under FDA or CBP
supervision to be the importer subject to
the examination and, thus, responsible
for paying this fee.
The fee is to cover all expenses
incurred in connection with arranging,
conducting, and evaluating the results
of the one or more additional
examinations that are described in
section V.A of this document.
For reconditioning, section 801(c) of
the FD&C Act directs the owner or
consignee to pay all expenses in
connection with the supervision of
reconditioning with respect to food and
certain other FDA-regulated products.
Those parties have been paying these
expenses, but FDA did not have
authority to retain those fees. FDA
considers the enactment of section 743
of the FD&C Act to mean that, for food,
FDA is now authorized to assess and
retain these fees, but only with respect
to the reconditioning of food and only
if the other conditions of section 743 are
met. If a fee is authorized under section
743 for a particular article of food, FDA
considers this to mean it cannot collect
a fee related to reconditioning that
article under section 801(c).
For destruction, section 801(c) of the
FD&C Act also directs the owner or
consignee to pay all expenses in
connection with the destruction of food
and certain other FDA-regulated
products under section 801(a). However,
neither FDA nor CBP have had the
authority to retain those fees. FDA
considers the enactment of section 743
of the FD&C Act to mean that, for food,
FDA is now authorized to assess and
retain these fees, but only with respect
to the destruction of food and only if the
other conditions of section 743 are met.
If a fee is authorized under section 743
for a particular article of food, FDA
considers this to mean it cannot collect
a fee related to destruction of that article
under section 801(c) of the FD&C Act.
The direct hours spent on each such
import reinspections will be billed at
the appropriate hourly rate shown in
table 3 of this document.
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45825
VI. How must the fees be paid?
An invoice will be sent to the
responsible party for paying the fee after
FDA completes the work on which the
invoice is based. Payment must be made
within 30 days of the invoice date in
U.S. currency by check, bank draft, or
U.S. postal money order payable to the
order of the Food and Drug
Administration. Detailed payment
information will be included with the
invoice when it is issued.
VII. What are the consequences of not
paying these user fees?
Under section 743(e)(2) of the FD&C
Act, any fee that is not paid within 30
days after it is due shall be treated as a
claim of the United States Government
subject to provisions of subchapter II of
chapter 37 of title 31, United States
Code.
VIII. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–19331 Filed 7–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0556]
Center for Devices and Radiological
Health 510(k) Clearance Process;
Institute of Medicine Report: ‘‘Medical
Devices and the Public’s Health, The
FDA 510(k) Clearance Process at 35
Years;’’ Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Request for comments.
The Food and Drug
Administration (FDA) is requesting
comments on the Institute of Medicine
(IOM) report entitled: ‘‘Medical Devices
and the Public’s Health, The FDA 510(k)
Clearance Process at 35 Years.’’ The
establishment of this public docket does
SUMMARY:
E:\FR\FM\01AUN1.SGM
01AUN1
45826
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
not signify FDA endorsement or
concurrence with any of the conclusions
or recommendations contained within
the report. FDA may, in the future, take
additional measures to solicit public
input in the report and specific
recommendations contained therein.
FDA will not adopt any of the
recommendations contained in the
report before the close of this comment
period.
DATES: Submit either electronic or
written comments on the report by
September 30, 2011.
ADDRESSES: See the SUPPLEMENTARY
INFORMATION section for electronic
access to the document. Submit
electronic comments on the preliminary
report to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5452, Silver Spring,
MD 20993–0002, 301–796–5678.
SUPPLEMENTARY INFORMATION:
I. Background
In September 2009, CDRH convened
an internal 510(k) Working Group as
part of a two-pronged, comprehensive
assessment of the 510(k) process. The
first prong of this evaluation consisted
of an internal evaluation of the 510(k)
process, resulting in the publication of
the CDRH preliminary internal
evaluation entitled: ‘‘510(k) Working
Group Preliminary Report and
Recommendations’’ (https://
www.fda.gov/downloads/AboutFDA/
CentersOffices/CDRH/CDRHReports/
UCM220784.pdf). This preliminary
report was intended to communicate
preliminary findings and
recommendations regarding the 510(k)
program and actions CDRH might take
to address identified areas of concern.
The report was issued on August 5,
2010 (75 FR 47307). After reviewing
public comment, CDRH issued a plan of
action for implementation of the
previously announced
recommendations on January 19, 2011
(https://www.fda.gov/downloads/
AboutFDA/CentersOffices/CDRH/
CDRHReports/UCM239450.pdf).
The second prong of the
comprehensive assessment of the 510(k)
process was an independent study by
the IOM. At the request of FDA, IOM
has evaluated the 510(k) clearance
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
process and made recommendations
aimed at protecting the health of the
public and making available a
mechanism to achieve timely access of
medial devices to the market. On July
29, 2011, IOM released the report
‘‘Medical Devices and the Public’s
Health, The FDA 510(k) Clearance
Process at 35 Years.’’ While FDA has not
yet had the opportunity to fully evaluate
this report, the agency does recognize
the strong public interest in the
comprehensive assessment of the 510(k)
process and the IOM report. For this
reason, FDA is opening a public docket
and requesting public comment on the
report. The establishment of this public
docket does not signify agency
endorsement or concurrence with any of
the conclusions or recommendations
contained within the report. FDA may,
in the future, take additional measures
to solicit public input in the report and
specific recommendations contained
therein. FDA will not adopt any of the
recommendations contained in the
report before the close of this comment
period.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
III. Electronic Access
The IOM report entitled: ‘‘Medical
Devices and the Public’s Health, The
FDA 510(k) Clearance Process at 35
Years’’ can be obtained from the IOM
Web site at https://www.iom.edu/
Activities/PublicHealth/
510KProcess.aspx.
Dated: July 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–19353 Filed 7–29–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0542]
Medical Device User Fee Rates for
Fiscal Year 2012
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2012. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Medical Device User
Fee Amendments of 2007 (title II of the
Food and Drug Administration
Amendments Act of 2007 (FDAAA)),
authorizes FDA to collect user fees for
certain medical device submissions, and
annual fees for certain periodic reports
and for certain establishments subject to
registration. The FY 2012 fee rates are
provided in this document. These fees
apply from October 1, 2011, through
September 30, 2012. To avoid delay in
the review of your application, you
should pay the fee before or at the time
you submit your application to FDA.
The fee you must pay is the fee that is
in effect on the later of the date that
your application is received by FDA or
the date your fee payment is received.
In order to pay a reduced small business
fee, you must qualify as a small business
before you make your submission to
FDA; if you do not qualify as a small
business before you make your
submission to FDA, you will be required
to pay the higher standard fee. This
document provides information on how
the fees for FY 2012 were determined,
the payment procedures you should
follow, and how you may qualify for
reduced small business fees.
SUMMARY:
For
information on the Medical Device User
Fee and Modernization Act (MDUFMA):
visit FDA’s Web site, https://
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Overview/
MedicalDeviceUserFeeand
ModernizationActMDUFMA/
default.htm.
For questions relating to this notice:
Contact David Miller, Office of
Financial Management (HFA–100),
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301–
796–7103.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45825-45826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19353]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0556]
Center for Devices and Radiological Health 510(k) Clearance
Process; Institute of Medicine Report: ``Medical Devices and the
Public's Health, The FDA 510(k) Clearance Process at 35 Years;''
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting comments
on the Institute of Medicine (IOM) report entitled: ``Medical Devices
and the Public's Health, The FDA 510(k) Clearance Process at 35
Years.'' The establishment of this public docket does
[[Page 45826]]
not signify FDA endorsement or concurrence with any of the conclusions
or recommendations contained within the report. FDA may, in the future,
take additional measures to solicit public input in the report and
specific recommendations contained therein. FDA will not adopt any of
the recommendations contained in the report before the close of this
comment period.
DATES: Submit either electronic or written comments on the report by
September 30, 2011.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to the document. Submit electronic comments on the preliminary
report to https://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678.
SUPPLEMENTARY INFORMATION:
I. Background
In September 2009, CDRH convened an internal 510(k) Working Group
as part of a two-pronged, comprehensive assessment of the 510(k)
process. The first prong of this evaluation consisted of an internal
evaluation of the 510(k) process, resulting in the publication of the
CDRH preliminary internal evaluation entitled: ``510(k) Working Group
Preliminary Report and Recommendations'' (https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf). This
preliminary report was intended to communicate preliminary findings and
recommendations regarding the 510(k) program and actions CDRH might
take to address identified areas of concern. The report was issued on
August 5, 2010 (75 FR 47307). After reviewing public comment, CDRH
issued a plan of action for implementation of the previously announced
recommendations on January 19, 2011 (https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf).
The second prong of the comprehensive assessment of the 510(k)
process was an independent study by the IOM. At the request of FDA, IOM
has evaluated the 510(k) clearance process and made recommendations
aimed at protecting the health of the public and making available a
mechanism to achieve timely access of medial devices to the market. On
July 29, 2011, IOM released the report ``Medical Devices and the
Public's Health, The FDA 510(k) Clearance Process at 35 Years.'' While
FDA has not yet had the opportunity to fully evaluate this report, the
agency does recognize the strong public interest in the comprehensive
assessment of the 510(k) process and the IOM report. For this reason,
FDA is opening a public docket and requesting public comment on the
report. The establishment of this public docket does not signify agency
endorsement or concurrence with any of the conclusions or
recommendations contained within the report. FDA may, in the future,
take additional measures to solicit public input in the report and
specific recommendations contained therein. FDA will not adopt any of
the recommendations contained in the report before the close of this
comment period.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
III. Electronic Access
The IOM report entitled: ``Medical Devices and the Public's Health,
The FDA 510(k) Clearance Process at 35 Years'' can be obtained from the
IOM Web site at https://www.iom.edu/Activities/PublicHealth/510KProcess.aspx.
Dated: July 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19353 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P
