81 FR 55462 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 161 (August 19, 2016)

Page Range		55462-55463
FR Document		2016-19807

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.

Federal Register, Volume 81 Issue 161 (Friday, August 19, 2016)

[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55462-55463]
From the Federal Register Online  [www.thefederalregister.org]
[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 [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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [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 (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

55462 Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices

The Panel charter provides that panel IV. Security, Building, and Parking review by the Office of Management and
meetings will be held up to four times Guidelines Budget under the authority of the
annually. The Panel consists of 15 The following are the security, Paperwork Reduction Act of 1995 (44
individuals and a Chair. The Panel building, and parking guidelines: U.S.C. 3501 et seq.).
Chair facilitates the meeting and the • Persons attending the meeting, Dated: August 4, 2016.
Designated Federal Official (DFO) or including presenters, must be pre- Andrew M. Slavitt,
DFO’s designee must be present at all registered and on the attendance list by Acting Administrator, Centers for Medicare
meetings. the prescribed date. & Medicaid Services.
II. Meeting Format and Agenda • Individuals who are not pre- [FR Doc. 2016–19848 Filed 8–18–16; 8:45 am]
registered in advance may not be BILLING CODE 4120–01–P
This meeting is open to the public. permitted to enter the building and may
The on-site check-in for visitors will be be unable to attend the meeting.
held from 8:30 a.m. to 9:00 a.m. on • Attendees must present a DEPARTMENT OF HEALTH AND
Monday, September 12, 2016. Following government-issued photo identification HUMAN SERVICES
the opening remarks, the Panel will hear to the Federal Protective Service or
oral presentations from the public for no Guard Service personnel before entering Food and Drug Administration
more than 1 hour during each of two the building. Without a current, valid
sessions, one session in the morning [Docket No. FDA–2013–N–0370]
photo ID, persons may not be permitted
and one session in the afternoon. During entry to the building. Agency Information Collection
session one, registered persons from the • Security measures include Activities; Submission for Office of
public may present recommendations inspection of vehicles, inside and out, at Management and Budget Review;
on payment options for routine the entrance to the grounds. Comment Request; Export of Medical
chemistry tests that are currently paid as • All persons entering the building Devices; Foreign Letters of Approval
Automated Test Panels (ATPs) must pass through a metal detector.
following implementation of the new • All items brought into CMS AGENCY: Food and Drug Administration,
payment system for clinical diagnostic including personal items, for example, HHS.
laboratory tests on January 1, 2018. laptops and cell phones are subject to ACTION: Notice.
During session two, registered persons physical inspection.
from the public may present • The public may enter the building SUMMARY: The Food and Drug
recommendations on the application 30 to 45 minutes before the meeting Administration (FDA) is announcing
process for Advanced Diagnostic convenes each day. that a proposed collection of
Laboratory Tests (ADLTs). • All visitors must be escorted in information has been submitted to the
The agenda for the September 12, areas other than the lower and first-floor Office of Management and Budget
2016, meeting will provide for levels in the Central Building. (OMB) for review and clearance under
discussion and comment on specified • The main-entrance guards will the Paperwork Reduction Act of 1995.
CLFS issues relevant to the final rule, issue parking permits and instructions DATES: Fax written comments on the
CMS–1621–F entitled, ‘‘Medicare upon arrival at the building. collection of information by September
Program; Medicare Clinical Diagnostic 19, 2016.
V. Special Accommodations
Laboratory Tests Payment System,’’ ADDRESSES: To ensure that comments on
which are designated in the Panel’s Individuals requiring special the information collection are received,
charter. Specifically, the Panel will accommodations must include the OMB recommends that written
discuss the following issues: request for these services during comments be faxed to the Office of
• Payment for routine chemistry tests registration. Information and Regulatory Affairs,
that are currently paid as ATPs VI. Panel Recommendations and OMB, Attn: FDA Desk Officer, FAX:
following implementation of the new Discussions 202–395–7285, or emailed to oira_
payment system for clinical diagnostic submission@omb.eop.gov. All
The Panel’s recommendations will be comments should be identified with the
laboratory tests on January 1, 2018. posted after the meeting on our Web site
• The application process for ADLTs. as specified in the ADDRESSES section of
OMB control number 0910–0264. Also
A detailed agenda will be posted include the FDA docket number found
this notice. in brackets in the heading of this
approximately 2 weeks before the
meeting, on the CMS Web site listed in VIII. Copies of the Charter document.
the ADDRESSES section of this notice. The Secretary’s Charter for the FOR FURTHER INFORMATION CONTACT: FDA
III. Meeting Attendance Advisory Panel on Clinical Diagnostic PRA Staff, Office of Operations, Food
Laboratory Tests is available on the and Drug Administration, Three White
The Panel’s meeting on September 12, CMS Web site as specified in the Flint North 10A–12M, 11601
2016, is open to the public. Priority will ADDRESSES section of this notice or you Landsdown St., North Bethesda, MD
be given to those who pre-register and may obtain a copy of the charter by 20852, PRAStaff@fda.hhs.gov.
attendance may be limited based on the submitting a request to the contact listed SUPPLEMENTARY INFORMATION: In
number of registrants and the space in the FOR FURTHER INFORMATION compliance with 44 U.S.C. 3507, FDA
available. CONTACT section of this notice. has submitted the following proposed
Persons wishing to attend this
mstockstill on DSK3G9T082PROD with NOTICES

collection of information to OMB for
meeting, which is located on federal IX. Collection of Information
review and clearance.
property, must register by following the Requirements
instructions in the DATES section of this This document does not impose Export of Medical Devices; Foreign
notice under ‘‘Meeting Registration.’’ A information collection requirements, Letters of Approval—OMB Control
confirmation email will be sent to the that is, reporting, recordkeeping or Number 0910–0264—Extension
registrants shortly after completing the third-party disclosure requirements. Section 801(e)(2) of the Federal Food,
registration process. Consequently, there is no need for Drug, and Cosmetic Act (the FD&C Act)

VerDate Sep<11>2014 18:08 Aug 18, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\19AUN1.SGM 19AUN1

Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices 55463

(21 U.S.C. 381(e)(2)) provides for the obtaining written authorization from the Agency of the United States. The
exportation of an unapproved device foreign government is to accept a respondents to this collection of
under certain circumstances if the notarized certification from a information are companies that seek to
exportation is not contrary to the public responsible company official in the export medical devices. FDA’s estimate
health and safety and it has the approval United States that the product is not in of the reporting burden is based on the
of the foreign country to which it is conflict with the foreign country’s laws. experience of FDA’s medical device
intended for export. Requesters This certification must include a program personnel.
communicate (either directly or through statement acknowledging that the
a business associate in the foreign responsible company official making the In the Federal Register of April 22,
country) with a representative of the certification is subject to the provisions 2016 (81 FR 23720), FDA published a
foreign government to which they seek of 18 U.S.C. 1001. This statutory 60-day notice requesting public
exportation, and written authorization provision makes it a criminal offense to comment on the proposed collection of
must be obtained from the appropriate knowingly and willingly make a false or information. No comments were
office within the foreign government fraudulent statement, or make or use a received.
approving the importation of the false document, in any manner within FDA estimates the burden of this
medical device. An alternative to the jurisdiction of a department or collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total oper-
Average
Number of responses Total annual ating and
Activity/Section of FD&C Act burden per Total hours
respondents per responses maintenance
response
respondent 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. submission@omb.eop.gov. All information showing that they meet the
Peter Lurie, comments should be identified with the equipment, personnel, quality
Associate Commissioner for Public Health OMB control number 0910–0309. Also assurance, and quality control
Strategy and Analysis. include the FDA docket number found standards, and have a medical reporting
[FR Doc. 2016–19807 Filed 8–18–16; 8:45 am] in brackets in the heading of this and recordkeeping program, a medical
BILLING CODE 4164–01–P document. outcomes audit program, and a
FOR FURTHER INFORMATION CONTACT: FDA consumer complaint mechanism. On the
PRA Staff, Office of Operations, Food basis of this accreditation, facilities are
DEPARTMENT OF HEALTH AND and Drug Administration, Three White then certified by FDA or an FDA-
HUMAN SERVICES Flint North,10A–12M, 11601 approved State certification agency and
Landsdown St., North Bethesda, MD must prominently display their
Food and Drug Administration
20852, PRAStaff@fda.hhs.gov. certificate. These actions are taken to
[Docket No. FDA–2013–N–0134] SUPPLEMENTARY INFORMATION: In ensure safe, accurate, and reliable
compliance with 44 U.S.C. 3507, FDA mammography on a nationwide basis.
Agency Information Collection has submitted the following proposed The following sections of Title 21 of
Activities; Submission for Office of collection of information to OMB for
Management and Budget Review; the Code of Federal Regulations (CFR)
review and clearance.
Comment Request; Mammography are not included in the burden tables
Quality Standards Act Requirements Mammography Quality Standards Act because they are considered usual and
Requirements—21 CFR Part 900, OMB customary practice and were part of the
AGENCY: Food and Drug Administration, Control Number 0910–0309—Extension standard of care prior to the
HHS. The Mammography Quality Standards implementation of the regulations.
ACTION: Notice. Act (Pub. L. 102–539) requires the Therefore, they resulted in no additional
establishment of a Federal certification burden: 21 CFR 900.12(c)(1) and (3) and
SUMMARY: The Food and Drug and inspection program for 900.3(f)(1). Section 900.24(c) was also
Administration (FDA) is announcing mammography facilities; regulations not included in the burden tables
that a proposed collection of and standards for accreditation and because if a certifying State had its
information has been submitted to the certification bodies for mammography approval withdrawn, FDA would take
Office of Management and Budget facilities; and standards for over certifying authority for the affected
(OMB) for review and clearance under mammography equipment, personnel,
the Paperwork Reduction Act of 1995. facilities. Because FDA already has all
and practices, including quality the certifying State’s electronic records,
DATES: Fax written comments on the assurance. The intent of these there wouldn’t be an additional
collection of information by September regulations is to assure safe, reliable, reporting burden.
19, 2016. and accurate mammography on a
mstockstill on DSK3G9T082PROD with NOTICES

ADDRESSES: To ensure that comments on nationwide level. Under the regulations, We have rounded numbers in the
the information collection are received, as a first step in becoming certified, ‘‘Total Hours’’ column in all three
OMB recommends that written mammography facilities must become burden tables. (Where the number was
comments be faxed to the Office of accredited by an FDA-approved a portion of 1 hour, it has been rounded
Information and Regulatory Affairs, accreditation body (AB). This requires to 1 hour. All other ‘‘Total Hours’’ have
OMB, Attn: FDA Desk Officer, FAX: undergoing a review of their clinical been rounded to the nearest whole
202–395–7285, or emailed to oira_ images and providing the AB with number.)

VerDate Sep<11>2014 18:08 Aug 18, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\19AUN1.SGM 19AUN1

Document Created: 2016-08-19 01:34:58
Document Modified: 2016-08-19 01:34:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by September 19, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 55462

81 FR 55462 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 161 (August 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration