Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval, 55462-55463 [2016-19807]
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55462
Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
The Panel charter provides that panel
meetings will be held up to four times
annually. The Panel consists of 15
individuals and a Chair. The Panel
Chair facilitates the meeting and the
Designated Federal Official (DFO) or
DFO’s designee must be present at all
meetings.
II. Meeting Format and Agenda
This meeting is open to the public.
The on-site check-in for visitors will be
held from 8:30 a.m. to 9:00 a.m. on
Monday, September 12, 2016. Following
the opening remarks, the Panel will hear
oral presentations from the public for no
more than 1 hour during each of two
sessions, one session in the morning
and one session in the afternoon. During
session one, registered persons from the
public may present recommendations
on payment options for routine
chemistry tests that are currently paid as
Automated Test Panels (ATPs)
following implementation of the new
payment system for clinical diagnostic
laboratory tests on January 1, 2018.
During session two, registered persons
from the public may present
recommendations on the application
process for Advanced Diagnostic
Laboratory Tests (ADLTs).
The agenda for the September 12,
2016, meeting will provide for
discussion and comment on specified
CLFS issues relevant to the final rule,
CMS–1621–F entitled, ‘‘Medicare
Program; Medicare Clinical Diagnostic
Laboratory Tests Payment System,’’
which are designated in the Panel’s
charter. Specifically, the Panel will
discuss the following issues:
• Payment for routine chemistry tests
that are currently paid as ATPs
following implementation of the new
payment system for clinical diagnostic
laboratory tests on January 1, 2018.
• The application process for ADLTs.
A detailed agenda will be posted
approximately 2 weeks before the
meeting, on the CMS Web site listed in
the ADDRESSES section of this notice.
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III. Meeting Attendance
The Panel’s meeting on September 12,
2016, is open to the public. Priority will
be given to those who pre-register and
attendance may be limited based on the
number of registrants and the space
available.
Persons wishing to attend this
meeting, which is located on federal
property, must register by following the
instructions in the DATES section of this
notice under ‘‘Meeting Registration.’’ A
confirmation email will be sent to the
registrants shortly after completing the
registration process.
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IV. Security, Building, and Parking
Guidelines
The following are the security,
building, and parking guidelines:
• Persons attending the meeting,
including presenters, must be preregistered and on the attendance list by
the prescribed date.
• Individuals who are not preregistered in advance may not be
permitted to enter the building and may
be unable to attend the meeting.
• Attendees must present a
government-issued photo identification
to the Federal Protective Service or
Guard Service personnel before entering
the building. Without a current, valid
photo ID, persons may not be permitted
entry to the building.
• Security measures include
inspection of vehicles, inside and out, at
the entrance to the grounds.
• All persons entering the building
must pass through a metal detector.
• All items brought into CMS
including personal items, for example,
laptops and cell phones are subject to
physical inspection.
• The public may enter the building
30 to 45 minutes before the meeting
convenes each day.
• All visitors must be escorted in
areas other than the lower and first-floor
levels in the Central Building.
• The main-entrance guards will
issue parking permits and instructions
upon arrival at the building.
V. Special Accommodations
Individuals requiring special
accommodations must include the
request for these services during
registration.
VI. Panel Recommendations and
Discussions
The Panel’s recommendations will be
posted after the meeting on our Web site
as specified in the ADDRESSES section of
this notice.
VIII. Copies of the Charter
The Secretary’s Charter for the
Advisory Panel on Clinical Diagnostic
Laboratory Tests is available on the
CMS Web site as specified in the
ADDRESSES section of this notice or you
may obtain a copy of the charter by
submitting a request to the contact listed
in the FOR FURTHER INFORMATION
CONTACT section of this notice.
IX. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
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review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: August 4, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–19848 Filed 8–18–16; 8:45 am]
BILLING CODE 4120–01–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) 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 September
19, 2016.
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 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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@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.
SUMMARY:
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)
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55463
Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
(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 April 22,
2016 (81 FR 23720), 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
Activity/Section of FD&C Act
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—section 801(e)(2) ........
38
1
38
3
114
$9,500
1 There
are no capital costs associated with this collection of information.
Dated: August 15, 2016.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0309. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North,10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@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.
[FR Doc. 2016–19807 Filed 8–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0134]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Mammography
Quality Standards Act Requirements
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 September
19, 2016.
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 oira_
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SUMMARY:
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Mammography Quality Standards Act
Requirements—21 CFR Part 900, OMB
Control Number 0910–0309—Extension
The Mammography Quality Standards
Act (Pub. L. 102–539) 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 (AB). This requires
undergoing a review of their clinical
images and providing the AB with
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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 complaint 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.
The following sections of Title 21 of
the Code of Federal Regulations (CFR)
are not included in the burden tables
because they are considered usual and
customary practice and were part of the
standard of care prior to the
implementation of the regulations.
Therefore, they resulted in no additional
burden: 21 CFR 900.12(c)(1) and (3) and
900.3(f)(1). Section 900.24(c) was also
not included in the burden tables
because if a certifying State had its
approval withdrawn, FDA would take
over certifying authority for the affected
facilities. Because FDA already has all
the certifying State’s electronic records,
there wouldn’t be an additional
reporting burden.
We have rounded numbers in the
‘‘Total Hours’’ column in all three
burden tables. (Where the number was
a portion of 1 hour, it has been rounded
to 1 hour. All other ‘‘Total Hours’’ have
been rounded to the nearest whole
number.)
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]]>Agencies
[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55462-55463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19807]
-----------------------------------------------------------------------
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) 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
September 19, 2016.
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 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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@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.
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)
[[Page 55463]]
(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 April 22, 2016 (81 FR 23720), 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average operating and
Activity/Section of FD&C Act respondents responses per responses burden per Total hours maintenance
respondent response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign letter of approval--section 801(e)(2)............. 38 1 38 3 114 $9,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Dated: August 15, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19807 Filed 8-18-16; 8:45 am]
BILLING CODE 4164-01-P
