Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval, 20660-20661 [2013-07915]
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20660
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
No. of
recordkeepers
No. of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Record retention, § 801.150(a)(2) ........................................
90
20
1,800
0.5 *
900
* (30 minutes)
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07916 Filed 4–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0370]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Export of Medical
Devices; Foreign Letters of Approval
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
reporting requirements for firms that
intend to export certain unapproved
medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by June 4, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:14 Apr 04, 2013
Jkt 229001
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
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
PO 00000
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Sfmt 4703
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 FD&C 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. The
respondents to this collection of
information are companies that seek to
export medical devices. FDA’s estimate
of the reporting burden is based on the
experience of FDA’s medical device
program personnel.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05APN1.SGM
05APN1
20661
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/section of FD&C Act
No. of
respondents
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total operating
& maintenance
costs
Foreign letter of approval—§ 801(e)(2) ....
38
1
38
3
114
$9,500
1 There
are no capital costs associated with this collection of information.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07915 Filed 4–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1093]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Additive
Petitions and Investigational Food
Additive Exemptions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 6,
2013.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0546. Also
include the FDA docket number found
ADDRESSES:
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food Additive Petitions and
Investigational Food Additive
Exemptions—(OMB Control Number
0910–0546)—Extension
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe
unless its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of the FD&C Act specifies
the information that must be submitted
by a petitioner in order to establish the
safety of a food additive and to secure
the issuance of a regulation permitting
its use.
To implement the provisions of
section 409 of the FD&C Act, procedural
regulations have been issued under part
571 (21 CFR part 571). These procedural
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broader terms by the FD&C Act.
The regulations add no substantive
requirements to those indicated in the
FD&C Act, but attempt to explain these
requirements and provide a standard
format for submission to speed
processing of the petition. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in parts 501, 573, and 579 (21
CFR parts 501, 573, and 579). The
labeling regulations are considered by
FDA to be cross-referenced to § 571.1,
which is the subject of this same OMB
clearance for food additive petitions.
With regard to the investigational use
of food additives, section 409(j) of the
FD&C Act provides that any food
additive or any food bearing or
containing such an additive, may be
exempted from the requirements of this
section if intended solely for
investigational use by qualified experts.
Investigational use of a food additive is
typically to address the safety and/or
intended physical or technical effect of
the additive.
To implement the provisions of
section 409(j) of the FD&C Act,
regulations have been issued under
§ 570.17 (21 CFR 570.17). These
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broad terms by the FD&C Act.
Labeling requirements for
investigational food additives are also
set forth in various regulations
contained in part 501. The labeling
regulations are considered by FDA to be
cross-referenced to § 570.17; which is
the subject of this same OMB clearance
for investigational food additive files. In
the Federal Register of November 13,
2012, (75 FR 67655), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
responses per
respondent
No. of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
Food Additive Petitions
571.1(c) moderate category ...................
517.1(c) complex category ....................
517.1(c) complex category ....................
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18:50 Apr 04, 2013
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1
1
2
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1
1
2
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1
4
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3,000
10,000
1,300
05APN1
3,000
10,000
5,200
]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20660-20661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07915]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0370]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Export of Medical Devices; Foreign Letters of Approval
AGENCY: Food and Drug Administration, HHS.
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 collection of
information, 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 either electronic or written comments on the collection
of information by June 4, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@fda.hhs.gov.
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
FD&C 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. The
respondents to this collection of information are companies that seek
to export medical devices. FDA's estimate of the reporting burden is
based on the experience of FDA's medical device program personnel.
FDA estimates the burden of this collection of information as
follows:
[[Page 20661]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Total operating
Activity/section of FD&C Act No. of responses per Total annual Average burden Total hours & maintenance
respondents respondent responses per response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign letter of approval--Sec. 801(e)(2)...... 38 1 38 3 114 $9,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07915 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P
