Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices-Foreign Letters of Approval, 55487-55488 [06-8026]
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55487
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS1
21 CFR Section
No. of Respondents
25.15(a) and (d)
25.40(a) and (c)
Total
1There
134
12
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–8025 Filed 9–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0380]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Export of Medical
Devices-Foreign Letters of Approval
Food and Drug Administration
Notice.
AGENCY:
sroberts on PROD1PC70 with NOTICES
Total Annual Responses
3.9
1.6
Hours per Respondent
421
14
8
2,160
Total Hours
3,368
30,240
33,608
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on information provided by
industry, FDA estimates that the
combined annual total burden hours for
all centers is 170,352.
ACTION:
Annual Frequency per
Response
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 information
collection, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
reporting requirements for firms that
intend to export certain unapproved
medical devices.
DATES: Submit written or electronic
comments on the collection of
information by November 21, 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.
VerDate Aug<31>2005
20:37 Sep 21, 2006
Jkt 208001
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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,301–827–1472.
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.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Export of Medical Devices-Foreign
Letters of Approval (OMB Control
Number 0910–0264)—Extension
Section 801(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 381(e)(2)) provides for the
exportation of an unapproved device
under certain circumstances if the
exportation is not contrary to the public
health and safety and it has the approval
of the foreign country to which it is
intended for export.
Requesters communicate (either
directly or through a business associate
in the foreign country) with a
representative of the foreign government
to which they seek exportation, and
written authorization must be obtained
from the appropriate office within the
foreign government approving the
importation of the medical device. An
alternative to obtaining written
authorization from the foreign
government is to accept a notarized
certification from a responsible
company official in the United States
that the product is not in conflict with
the foreign country’s laws. This
certification must include a statement
acknowledging that the responsible
company official making the
certification is subject to the provisions
of 18 U.S.C. 1001. This statutory
provision makes it a criminal offense to
knowingly and willingly make a false or
fraudulent statement, or make or use a
false document, in any manner within
the jurisdiction of a department or
agency of the United States.
FDA uses the written authorization
from the foreign country or the
certification from a responsible
company official in the United States to
determine whether the foreign country
has any objection to the importation of
the device into their country.
The respondents to this collection of
information are companies that seek to
export medical devices.
FDA estimates the reporting burden of
this collection of information as follows:
E:\FR\FM\22SEN1.SGM
22SEN1
55488
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
801(e)(2)
1There
25
Total Annual
Responses
1
Hours per
Response
25
Total Hours
2.5
62.5
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates are based on the
experience of FDA’s medical device
program personnel.
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–8026 Filed 9–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0381]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mammography
Quality Standards Act Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Annual Frequency
per Response
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
the estimated reporting and
recordkeeping burden associated with
the Mammography Quality Standards
Act requirements.
DATES: Submit written or electronic
comments on the collection of
information by November 21, 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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
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.
The Mammography Quality Standards
Act Requirements—21 CFR Part 900
(OMB Control Number 0910–0309)—
Extension
The Mammography Quality Standards
Act requires the establishment of a
Federal certification and inspection
program for mammography facilities;
regulations and standards for
accreditation and certification bodies for
mammography facilities, and standards
for mammography equipment,
personnel, and practices, including
quality assurance. The intent of these
regulations is to assure safe, reliable,
and accurate mammography on a
nationwide level.
Under the regulations, as a first step
in becoming certified, mammography
facilities must become accredited by an
FDA approved accreditation body. This
requires undergoing a review of their
clinical images and providing the
accreditation body with information
showing that they meet the equipment,
personnel, quality assurance and quality
control standards, and have a medical
reporting and recordkeeping program, a
medical outcomes audit program, and a
consumer compliant mechanism. On the
basis of this accreditation, facilities are
then certified by FDA or an FDAapproved State certification agency and
must prominently display their
certificate. These actions are taken to
ensure safe, accurate, and reliable
mammography on a nationwide basis.
FDA estimates the burden of this
collection of information as follows:
sroberts on PROD1PC70 with NOTICES
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section/
FDA Form
No. of
Respondents
Annual
Frequency
perResponse
Total Annual
Records
Hours per
Response
Total Hours
900.3(b)(1)
0.33
1
0.33
1
0.33
900.3(b)(3) full1
0.33
1
0.33
320
Total Capital
Costs
106
VerDate Aug<31>2005
20:37 Sep 21, 2006
Jkt 208001
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
E:\FR\FM\22SEN1.SGM
$10,000
22SEN1
Total Operating &
Maintenance Costs
]]>Agencies
[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55487-55488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0380]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Export of Medical Devices-Foreign Letters of Approval
AGENCY: Food and Drug Administration
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 information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements for
firms that intend to export certain unapproved medical devices.
DATES: Submit written or electronic comments on the collection of
information by November 21, 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: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,301-827-1472.
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.
Export of Medical Devices-Foreign Letters of Approval (OMB Control
Number 0910-0264)--Extension
Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 381(e)(2)) provides for the exportation of an
unapproved device under certain circumstances if the exportation is not
contrary to the public health and safety and it has the approval of the
foreign country to which it is intended for export.
Requesters communicate (either directly or through a business
associate in the foreign country) with a representative of the foreign
government to which they seek exportation, and written authorization
must be obtained from the appropriate office within the foreign
government approving the importation of the medical device. An
alternative to obtaining written authorization from the foreign
government is to accept a notarized certification from a responsible
company official in the United States that the product is not in
conflict with the foreign country's laws. This certification must
include a statement acknowledging that the responsible company official
making the certification is subject to the provisions of 18 U.S.C.
1001. This statutory provision makes it a criminal offense to knowingly
and willingly make a false or fraudulent statement, or make or use a
false document, in any manner within the jurisdiction of a department
or agency of the United States.
FDA uses the written authorization from the foreign country or the
certification from a responsible company official in the United States
to determine whether the foreign country has any objection to the
importation of the device into their country.
The respondents to this collection of information are companies
that seek to export medical devices.
FDA estimates the reporting burden of this collection of
information as follows:
[[Page 55488]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
801(e)(2) 25 1 25 2.5 62.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates are based on the experience of FDA's medical
device program personnel.
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8026 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S
