81 FR 24041 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 79 (April 25, 2016)

Page Range		24041-24042
FR Document		2016-09443

The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled ``Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers'' that appeared in the Federal Register of March 4, 2016. In the document, FDA requested comments about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments. The Agency is taking this action due to the unanticipated high-level of interest from interested persons.

Federal Register, Volume 81 Issue 79 (Monday, April 25, 2016)

[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Proposed Rules]
[Pages 24041-24042]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09443]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / 
Proposed Rules

[[Page 24041]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

[Docket No. FDA-2016-N-0436]


Refurbishing, Reconditioning, Rebuilding, Remarketing, 
Remanufacturing, and Servicing of Medical Devices Performed by Third-
Party Entities and Original Equipment Manufacturers; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the document entitled ``Refurbishing, 
Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing 
of Medical Devices Performed by Third-Party Entities and Original 
Equipment Manufacturers'' that appeared in the Federal Register of 
March 4, 2016. In the document, FDA requested comments about the 
quality, safety, and continued effectiveness of medical devices that 
have been subject to one or more of these activities that are performed 
by both original equipment manufacturers (OEM) and third parties, 
including health care establishments. The Agency is taking this action 
due to the unanticipated high-level of interest from interested 
persons.

DATES: FDA is extending the comment period on the document published 
March 4, 2016 (81 FR 11477). Submit either electronic or written 
comments by June 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0436 for ``Refurbishing, Reconditioning, Rebuilding, 
Remarketing, Remanufacturing, and Servicing of Medical Devices 
Performed by Third-Party Entities and Original Equipment Manufacturers; 
Request for Comments.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie Flournoy, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5495.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 4, 2016, FDA published a document 
with a 60-day comment period to request comments on the medical device 
industry and healthcare community that refurbish, recondition, rebuild, 
remarket, remanufacture, service, and

[[Page 24042]]

repair medical devices (hereafter termed ``third-party entity or 
entities''), including radiation-emitting devices subject to the 
electronic product radiation control (EPRC) provisions of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act). Comments on the service, 
maintenance, refurbishment, and alteration of medical devices, by 
third-party entities as well as challenges third-party entities face in 
maintaining or restoring devices to their original or current 
specifications will inform FDA when we hold a public meeting later in 
2016 to further engage this segment of the device industry and 
healthcare community.
    The Agency has received requests for a 30-day extension of the 
comment period for the document. Each request conveyed concern that the 
current 60-day comment period does not allow sufficient time to develop 
meaningful or thoughtful response to the document on ``Refurbishing, 
Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing 
of Medical Devices Performed by Third-Party Entities and Original 
Equipment Manufacturers.''
    FDA has considered the requests and is extending the comment period 
for the document on ``Refurbishing, Reconditioning, Rebuilding, 
Remarketing, Remanufacturing, and Servicing of Medical Devices 
Performed by Third-Party Entities and Original Equipment 
Manufacturers'' for 30 days, until June 3, 2016. The Agency believes 
that a 30-day extension allows adequate time for interested persons to 
submit comments without significantly delaying future workshop on these 
important issues.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09443 Filed 4-22-16; 8:45 am]
BILLING CODE 4164-01-P

24042 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules

repair medical devices (hereafter termed the public to request from ODNI a Authority: 50 U.S.C. 3001; E.O. 13526, 75
‘‘third-party entity or entities’’), Mandatory Declassification Review FR 707, 3 CFR, 2009 Comp, p. 298.
including radiation-emitting devices (MDR) of information classified under § 1704.1 Authority and purpose.
subject to the electronic product the provisions of Executive Order 13526
radiation control (EPRC) provisions of or predecessor orders such that the (a) Authority. This part is issued
the Federal Food, Drug, and Cosmetic agency may retrieve it with reasonable under the authority of 32 CFR 2001.33;
Act (the FD&C Act). Comments on the effort. This rule also informs requesters Section 3.5 of Executive Order 13526 (or
service, maintenance, refurbishment, where to send requests for an MDR. successor Orders); the National Security
and alteration of medical devices, by Act of 1947, as amended (50 U.S.C. 3001
DATES: Submit comments on or before et seq.).
third-party entities as well as challenges May 25, 2016.
third-party entities face in maintaining (b) Purpose. This part prescribes
ADDRESSES: You may submit comments procedures, subject to limitations set
or restoring devices to their original or
current specifications will inform FDA by any of the following methods: By forth below, for requesters to request a
when we hold a public meeting later in mail to the Office of the Director of mandatory declassification review of
2016 to further engage this segment of National Intelligence, Director of the information classified under Executive
the device industry and healthcare Information Management Division, Order 13526 or predecessor or successor
community. Washington, DC 20511, by facsimile at orders. Section 3.5 of Executive Order
The Agency has received requests for (703) 874–8910, or by email at dni- 13526 and these regulations are not
a 30-day extension of the comment FOIA@dni.gov. intended to and do not create any right
period for the document. Each request FOR FURTHER INFORMATION CONTACT: or benefit, substantive or procedural,
conveyed concern that the current 60- Jennifer L. Hudson, 703–874–8085. enforceable at law by a party against the
day comment period does not allow SUPPLEMENTARY INFORMATION: It is the United States, its agencies, officers,
sufficient time to develop meaningful or policy of the ODNI to act in matters employees, or agents, or any other
thoughtful response to the document on relating to national security information person.
‘‘Refurbishing, Reconditioning, in accordance with Executive Order § 1704.2 Definitions.
Rebuilding, Remarketing, 13526 and directives issued thereunder
Remanufacturing, and Servicing of For purposes of this part:
by the Information Security Oversight Control means the authority of the
Medical Devices Performed by Third- Office (ISOO). The purpose of this rule agency that originates information, or its
Party Entities and Original Equipment is to assist in implementing specific successor in function, to regulate access
Manufacturers.’’ sections of Executive Order 13526
FDA has considered the requests and to the information. (32 CFR 2001.92)
concerning the Mandatory Day means U.S. Federal Government
is extending the comment period for the Declassification Review (MDR).
document on ‘‘Refurbishing, working day, which excludes Saturdays,
Reconditioning, Rebuilding, Regulatory Impact Sundays, and federal holidays. Three (3)
Remarketing, Remanufacturing, and days may be added to any time limit
This proposed rule is not a significant
Servicing of Medical Devices Performed imposed on a requester by this part if
regulatory action for the purposes of
by Third-Party Entities and Original responding by U.S. domestic mail; ten
Executive Order 12866. This rule is not
Equipment Manufacturers’’ for 30 days, (10) days may be added if responding by
a major rule as defined in 5 U.S.C.
until June 3, 2016. The Agency believes international mail.
Chapter 8, Congressional Review of
that a 30-day extension allows adequate D/IMD means the Director of the
Agency Rulemaking. As required by the
time for interested persons to submit Information Management Division and
Regulatory Flexibility Act, we certify
comments without significantly the leader of any successor organization,
that this proposed rule will not have a
delaying future workshop on these who serves as the ODNI’s manager of
significant impact on a substantial
important issues. the information review and release
number of small entities because it
program.
Dated: April 19, 2016. applies only to Federal agencies.
Federal agency means any Executive
Leslie Kux, List of Subjects in 32 CFR Part 1704 agency, as defined in 5 U.S.C. 105; any
Associate Commissioner for Policy. Military department, as defined in 5
Declassification, Information,
[FR Doc. 2016–09443 Filed 4–22–16; 8:45 am] U.S.C. 102; and any other entity within
Intelligence, National security
BILLING CODE 4164–01–P the executive branch that comes into the
information.
possession of classified information.
■ For the reasons set forth in the Information means any knowledge
preamble, ODNI proposes to add 32 CFR that can be communicated or
OFFICE OF THE DIRECTOR OF
part 1704 to read as follows: documentary material, regardless of its
NATIONAL INTELLIGENCE
physical form that is owned by,
PART 1704—MANDATORY
32 CFR Part 1704 produced by or for, or under the control
DECLASSIFICATION REVIEW
of the U.S. Government; it does not
Mandatory Declassification Review PROGRAM
include information originated by the
Program Sec. incumbent President, White House
1704.1 Authority and purpose. Staff, appointed committees,
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS

AGENCY: Office of the Director of
National Intelligence. 1704.2 Definitions. commissions or boards, or any entities
1704.3 Contact information. within the Executive Office that solely
ACTION: Proposed rule. 1704.4 MDR program feedback. advise and assist the incumbent
1704.5 Guidance.
SUMMARY: The Office of the Director of President.
1704.6 Exceptions.
National Intelligence (ODNI) is 1704.7 Requirements.
Interested party means any official in
publishing this proposed rule pursuant 1704.8 Fees. the executive, military, congressional, or
to Executive Order 13526, relating to 1704.9 Determination by originator or judicial branches of government, or U.S.
classified national security information. interested party. Government contractor who, in the sole
It provides procedures for members of 1704.10 Appeals. discretion of the ODNI, has a subject

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Document Created: 2016-04-23 01:39:17
Document Modified: 2016-04-23 01:39:17

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		Proposed Rules
Action		Notification; extension of comment period.
Dates		FDA is extending the comment period on the document published March 4, 2016 (81 FR 11477). Submit either electronic or written comments by June 3, 2016.
Contact		Valerie Flournoy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5495.
FR Citation		81 FR 24041

81 FR 24041 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 79 (April 25, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration