Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval, 35874-35875 [2019-15790]
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35874
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
to provide additional information about
the circumstances under which FDA
would consider non-compliance to be
materially related to a food safety
requirement of the FD&C Act.
Under section 743(a)(1)(A) of the
FD&C Act, FDA is directed to assess and
collect fees from ‘‘the responsible party
for each domestic facility (as defined in
section 415(b) (21 U.S.C. 350d(b))) and
the United States agent for each foreign
facility subject to a reinspection’’ to
cover reinspection-related costs.
Section 743(a)(2)(A)(i) of the FD&C
Act defines the term ‘‘reinspection’’
with respect to domestic facilities as ‘‘1
or more inspections conducted under
section 704 subsequent to an inspection
conducted under such provision which
identified non-compliance materially
related to a food safety requirement of
th[e] Act, specifically to determine
whether compliance has been achieved
to the Secretary’s satisfaction.’’
The FD&C Act does not contain a
definition of ‘‘reinspection’’ specific to
foreign facilities. In order to give
meaning to the language in section
743(a)(1)(A) of the FD&C Act to collect
fees from the U.S. agent of a foreign
facility subject to a reinspection, the
Agency is using the following definition
of ‘‘reinspection’’ for purposes of
assessing and collecting fees under
section 743(a)(1)(A), with respect to a
foreign facility, ‘‘1 or more inspections
conducted by officers or employees duly
designated by the Secretary subsequent
to such an inspection which identified
non-compliance materially related to a
food safety requirement of the FD&C
Act, specifically to determine whether
compliance has been achieved to the
Secretary’s (and, by delegation, FDA’s)
satisfaction.’’
This definition allows FDA to fulfill
the mandate to assess and collect fees
from the U.S. agent of a foreign facility
in the event that an inspection reveals
non-compliance materially related to a
food safety requirement of the FD&C
Act, causing one or more subsequent
inspections to determine whether
compliance has been achieved to the
Secretary’s (and, by delegation, FDA’s)
satisfaction. By requiring the initial
inspection to be conducted by officers
or employees duly designated by the
Secretary, the definition ensures that a
foreign facility would be subject to fees
only in the event that FDA, or an entity
designated to act on its behalf, has made
the requisite identification at an initial
inspection of non-compliance materially
related to a food safety requirement of
the FD&C Act. The definition of
‘‘reinspection-related costs’’ in section
743(a)(2)(B) of the FD&C Act relates to
both a domestic facility reinspection
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and a foreign facility reinspection, as
described in section 743(a)(1)(A).
B. Who will be responsible for paying
this fee?
The FD&C Act states that this fee is to
be paid by the responsible party for each
domestic facility (as defined in section
415(b) of the FD&C Act) and by the U.S.
agent for each foreign facility (section
743(a)(1)(A) of the FD&C Act). This is
the party to whom FDA will send the
invoice for any fees that are assessed
under this section.
C. How much will this fee be?
The fee is based on the number of
direct hours spent on such
reinspections, including time spent
conducting the physical surveillance
and/or compliance reinspection at the
facility, or whatever components of
such an inspection are deemed
necessary, making preparations and
arrangements for the reinspection,
traveling to and from the facility,
preparing any reports, analyzing any
samples or examining any labels if
required, and performing other activities
as part of the OAI reinspection until the
facility is again determined to be in
compliance. The direct hours spent on
each such reinspection will be billed at
the appropriate hourly rate shown in
table 2 of this document.
IV. Fees for Non-Compliance With a
Recall Order Under Section 743(a)(1)(B)
A. What will cause this fee to be
assessed?
The fee will be assessed for not
complying with a recall order under
section 423(d) (21 U.S.C. 350l(d)) or
section 412(f) of the FD&C Act (21
U.S.C. 350a(f)) to cover food recall
activities associated with such order
performed by the Secretary (and by
delegation, FDA) (section 743(a)(1)(B) of
the FD&C Act). Non-compliance may
include the following: (1) Not initiating
a recall as ordered by FDA; (2) not
conducting the recall in the manner
specified by FDA in the recall order; or
(3) not providing FDA with requested
information regarding the recall, as
ordered by FDA.
B. Who will be responsible for paying
this fee?
Section 743(a)(1)(B) of the FD&C Act
states that the fee is to be paid by the
responsible party for a domestic facility
(as defined in section 415(b) of the
FD&C Act) and an importer who does
not comply with a recall order under
section 423 or under section 412(f) of
the FD&C Act. In other words, the party
paying the fee would be the party that
received the recall order.
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C. How much will this fee be?
The fee is based on the number of
direct hours spent on taking action in
response to the firm’s failure to comply
with a recall order. Types of activities
could include conducting recall audit
checks, reviewing periodic status
reports, analyzing the status reports and
the results of the audit checks,
conducting inspections, traveling to and
from locations, and monitoring product
disposition. The direct hours spent on
each such recall will be billed at the
appropriate hourly rate shown in table
2 of this document.
V. 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 90 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.
VI. What Are the Consequences of Not
Paying These 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 U.S. Government subject to
provisions of subchapter II of chapter 37
of title 31, United States Code.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15817 Filed 7–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0370]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Medical
Devices; Foreign Letters of Approval
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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.
SUMMARY:
E:\FR\FM\25JYN1.SGM
25JYN1
35875
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
Fax written comments on the
collection of information by August 26,
2019.
DATES:
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 0910–0264. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
collection of information to OMB for
review and clearance.
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 (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.
In the Federal Register of March 11,
2019 (84 FR 8727), FDA published a 60day 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/FD&C Act section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total
operating
and
maintenance
costs
Foreign letter of approval—801(e)(2) .............................................................
33
1
33
3
99
$8,250
1 There
are no capital costs associated with this collection of information.
We have adjusted our burden estimate
by decreasing the number of
respondents by 5, which has resulted in
a corresponding decrease of 15 hours to
the currently approved hour burden and
$1,250 to the total operating and
maintenance costs. This adjustment is
based on a decrease in the number of
submissions we received over the last
few years.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0305]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Deeming Tobacco
Products To Be Subject to the Federal
Food, Drug, and Cosmetic Act
AGENCY:
[FR Doc. 2019–15790 Filed 7–24–19; 8:45 am]
HHS.
BILLING CODE 4164–01–P
ACTION:
Food and Drug Administration,
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 August 26,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
jspears on DSK30JT082PROD with NOTICES
SUMMARY:
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16:56 Jul 24, 2019
Jkt 247001
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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 0910–0768. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\25JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35874-35875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15790]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0370]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 or we) 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.
[[Page 35875]]
DATES: Fax written comments on the collection of information by August
26, 2019.
ADDRESSES: 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 [email protected]. All
comments should be identified with the OMB control number 0910-0264.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
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 (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.
In the Federal Register of March 11, 2019 (84 FR 8727), 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:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
Number of responses Total annual Average operating and
Activity/FD&C Act section respondents per responses burden per Total hours maintenance
respondent response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign letter of approval--801(e)(2)............................. 33 1 33 3 99 $8,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
We have adjusted our burden estimate by decreasing the number of
respondents by 5, which has resulted in a corresponding decrease of 15
hours to the currently approved hour burden and $1,250 to the total
operating and maintenance costs. This adjustment is based on a decrease
in the number of submissions we received over the last few years.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15790 Filed 7-24-19; 8:45 am]
BILLING CODE 4164-01-P
