Notice of Interest Rate on Overdue Debts, 49384-49385 [2017-23092]
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
This guidance specifically addresses
software design and technology
modifications, including firmware. This
guidance does not apply to software for
which the Agency has stated in
guidance that it does not intend to
enforce compliance with applicable
regulatory controls (e.g., ‘‘Mobile
Medical Applications: Guidance for
Industry and FDA Staff,’’ issued
February 9, 2015, available on the
internet at https://www.fda.gov/
downloads/medicaldevices/.../
ucm263366.pdf) and software that does
not meet the definition of a medical
device at section 201(h) of the FD&C Act
(21 U.S.C. 321(h)).
In the Federal Register on August 8,
2016, FDA announced the availability of
the draft guidance and interested parties
were requested to comment by
November 7, 2016. FDA considered
comments received on the draft
guidance and revised the guidance as
appropriate.
This guidance is not intended to
implement significant policy changes to
FDA’s current thinking on when
submission of a new 510(k) is required
for a software change to an existing
device. Rather, the intent of this
guidance is to enhance the
predictability, consistency, and
transparency of the ‘‘when to submit’’
decision-making process by providing a
least burdensome approach, and
describing in greater detail the
regulatory framework, policies, and
practices underlying such a decision,
specifically as it relates to software
changes. The recommendations
discussed in this guidance for
evaluating when a software change to an
existing device would trigger the
requirement that a manufacturer submit
a new 510(k) to the Agency are
consistent with the least burdensome
principles (Refs. 1 and 2). This guidance
applies the least burdensome principles,
in part, by reliance on risk management
and the quality system regulation (21
CFR part 820) to determine whether
submission of a new 510(k) is required
for a software change to an existing
device.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of the guidance document
entitled ‘‘Deciding When to Submit a
510(k) for a Change to an Existing
Device,’’ to aid manufacturers of
medical devices who intend to make
non-software changes to an existing
device during the process of deciding
whether the modification exceeds the
regulatory threshold of § 807.81(a)(3) for
submission and clearance of a new
510(k).
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II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Deciding When to
Submit a 510(k) for a Software Change
to an Existing Device.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of
‘‘Deciding When to Submit a 510(k) for
a Software Change to an Existing
Device’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number
1500055 to identify the guidance you
are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 820 are approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 807, subpart E are approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 803 are approved under OMB
control number 0910–0437; and the
collections of information in 21 CFR
parts 801 are approved under OMB
control number 0910–0485.
V. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
PO 00000
Frm 00074
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through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. ‘‘The Least Burdensome Provisions of the
FDA Modernization Act of 1997:
Concept and Principles,’’ dated October
4, 2002, available at: https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm085999.pdf.
2. ‘‘Suggested Format for Developing and
Responding to Deficiencies in
Accordance with the Least Burdensome
Provisions of FDAMA,’’ dated November
2, 2000, available at: https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm073680.pdf.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23196 Filed 10–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Interest Rate on Overdue
Debts
Section 30.18 of the Department of
Health and Human Services’ claims
collection regulations (45 CFR part 30)
provides that the Secretary shall charge
an annual rate of interest, which is
determined and fixed by the Secretary
of the Treasury after considering private
consumer rates of interest on the date
that the Department of Health and
Human Services becomes entitled to
recovery. The rate cannot be lower than
the Department of Treasury’s current
value of funds rate or the applicable rate
determined from the ‘‘Schedule of
Certified Interest Rates with Range of
Maturities’’ unless the Secretary waives
interest in whole or part, or a different
rate is prescribed by statute, contract, or
repayment agreement. The Secretary of
the Treasury may revise this rate
quarterly. The Department of Health and
Human Services publishes this rate in
the Federal Register.
The current rate of 93⁄4%, as fixed by
the Secretary of the Treasury, is certified
for the quarter ended September 30,
2017. This rate is based on the Interest
Rates for Specific Legislation, ‘‘National
Health Services Corps Scholarship
Program (42 U.S.C. 254o(b)(1)(A))’’ and
‘‘National Research Service Award
Program (42 U.S.C. 288(c)(4)(B)).’’ This
interest rate will be applied to overdue
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
debt until the Department of Health and
Human Services publishes a revision.
paragraph at the end of the section with
the following:
Dated: October 17, 2017.
David C. Horn,
Director, Office of Financial Policy and
Reporting.
Office of Security and Strategic
Information (ABE)
The Office of Security and Strategic
Information is headed by the Assistant
Deputy Secretary for National Security,
who reports directly to the Deputy
Secretary and also serves as the
Secretary’s Senior Intelligence Official
on intelligence and counterintelligence
issues. The Assistant Deputy Secretary
for National Security has been delegated
original classification authority by the
Secretary. The Assistant Deputy
Secretary for National Security manages
the Office of Security and Strategic
Information (OSSI). OSSI’s vision is for
HHS personnel to successfully
accomplish missions worldwide in a
security-informed manner and with the
actionable intelligence needed, at the
right time, for operational and policy
decisions. OSSI’s responsibilities
include: Integrating intelligence and
security information into HHS policy
and operational decisions; assessing,
anticipating, and warning of potential
security threats to the Department and
our national security; and, providing
policy guidance on and managing the
OS implementation of the Department’s
security, intelligence and
counterintelligence programs. OSSI’s
programs include national security
adjudication, classified national security
information management, secure
compartmented information facilities
management, communications security,
safeguarding and sharing of classified
information, cyber threat intelligence,
and counterintelligence. In coordination
with the Director of National
Intelligence, OSSI has been designated
as a Federal Intelligence Coordinating
Office and the Assistant Deputy
Secretary for National Security serves as
the HHS Federal Senior Intelligence
Coordinator. OSSI has responsibilities
to establish implementing guidance,
provide oversight, and manage the
Department’s policy for the sharing,
safeguarding, and coordinated exchange
of information related to national or
homeland security with other federal
departments and agencies, including
law enforcement organizations and the
Intelligence Community, in compliance
with HHS policies and applicable laws,
regulations, and Executive Orders.
E. Delegation of Authority. Pending
further redelegation, directives or orders
made by the Secretary or Deputy
Secretary, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
[FR Doc. 2017–23092 Filed 10–24–17; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
sradovich on DSK3GMQ082PROD with NOTICES
Office of the Assistant Secretary for
Administration; Statement of
Organization, Functions, and
Delegations of Authority
Part A, Office of the Secretary,
Statement of Organization, Functions,
and Delegations of Authority for the
Department of Health and Human
Services (HHS) is being amended at Part
A, Chapter AJ, Office of the Assistant
Secretary for Administration (ASA),
which was last amended at 77 FR 2729,
dated January 19, 2012, and most
recently at 77 FR 71004, dated
November 28, 2012. Part A, Chapter AB,
Section AB.20 a paragraph on Office of
Security and Strategic Information
(ABE), is being inserted. Part P, Program
Support Center (PSC), Statement of
Organization, Functions, and
Delegations of Authority, which was last
amended at 75 FR 369–370, dated
January 5, 2010, is not being amended.
This notice transfers the onboarding/
suitability and physical security
functions of the Office for Security and
Strategic Information (OSSI) to PSC.
This transfer of functions complements
the existing PSC component’s facilities
management functions, parking garage
entrance, safety-related programs, and
other administrative functions. This
notice also updates information
regarding OSSI’s direct report to the
Deputy Secretary, organizational
structure, as well as the new roles and
responsibilities for the Assistant Deputy
Secretary for National Security and
Secretary’s Senior Intelligence Official
and for OSSI.
A. Part P, Program Support Center,
the statement of organization, functions,
and delegations of Authority therein
need not be changed as the transferred
functions are within the scope of the
functions of PSC as described.
B. Under Chapter AJ, Section AJ.20,
Functions, delete the last paragraph,
which begins with ‘‘Office of Security
and Strategic Information (AJS),’’ in its
entirety.
C. Under Chapter AB, Section AB.20,
Functions, insert the following new
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49385
pending further redelegations, provided
they are consistent with this
reorganization.
Eric D. Hargan,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2017–23091 Filed 10–24–17; 8:45 am]
BILLING CODE 4151–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Infrastructure
Development for Interdisciplinary Aging
Studies.
Date: November 21, 2017.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201
Wisconsin Ave., Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Isis S. Mikhail, MD, MPH,
DRPH, National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7704,
MIKHAILI@MAIL.NIH.GOV.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: October 19, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–23127 Filed 10–24–17; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49384-49385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23092]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Notice of Interest Rate on Overdue Debts
Section 30.18 of the Department of Health and Human Services'
claims collection regulations (45 CFR part 30) provides that the
Secretary shall charge an annual rate of interest, which is determined
and fixed by the Secretary of the Treasury after considering private
consumer rates of interest on the date that the Department of Health
and Human Services becomes entitled to recovery. The rate cannot be
lower than the Department of Treasury's current value of funds rate or
the applicable rate determined from the ``Schedule of Certified
Interest Rates with Range of Maturities'' unless the Secretary waives
interest in whole or part, or a different rate is prescribed by
statute, contract, or repayment agreement. The Secretary of the
Treasury may revise this rate quarterly. The Department of Health and
Human Services publishes this rate in the Federal Register.
The current rate of 9\3/4\%, as fixed by the Secretary of the
Treasury, is certified for the quarter ended September 30, 2017. This
rate is based on the Interest Rates for Specific Legislation,
``National Health Services Corps Scholarship Program (42 U.S.C.
254o(b)(1)(A))'' and ``National Research Service Award Program (42
U.S.C. 288(c)(4)(B)).'' This interest rate will be applied to overdue
[[Page 49385]]
debt until the Department of Health and Human Services publishes a
revision.
Dated: October 17, 2017.
David C. Horn,
Director, Office of Financial Policy and Reporting.
[FR Doc. 2017-23092 Filed 10-24-17; 8:45 am]
BILLING CODE 4150-04-P
