82 FR 49384 - Notice of Interest Rate on Overdue Debts
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 82, Issue 205 (October 25, 2017)
Office of the Secretary
Federal Register Volume 82, Issue 205 (October 25, 2017)
| Page Range | 49384-49385 | |
| FR Document | 2017-23092 |
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)] [Notices] [Pages 49384-49385] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23092] ----------------------------------------------------------------------- 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
![49384 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
This guidance specifically addresses II. Significance of Guidance through Friday; they are also available
software design and technology This guidance is being issued electronically at https://
modifications, including firmware. This consistent with FDA’s good guidance www.regulations.gov. FDA has verified
guidance does not apply to software for practices regulation (21 CFR 10.115). the Web site addresses, as of the date
which the Agency has stated in The guidance represents the current this document publishes in the Federal
guidance that it does not intend to thinking of FDA on ‘‘Deciding When to Register, but Web sites are subject to
enforce compliance with applicable Submit a 510(k) for a Software Change change over time.
regulatory controls (e.g., ‘‘Mobile to an Existing Device.’’ It does not 1. ‘‘The Least Burdensome Provisions of the
Medical Applications: Guidance for establish any rights for any person and FDA Modernization Act of 1997:
Industry and FDA Staff,’’ issued is not binding on FDA or the public. Concept and Principles,’’ dated October
February 9, 2015, available on the You can use an alternative approach if 4, 2002, available at: https://
internet at https://www.fda.gov/ www.fda.gov/downloads/Medical
it satisfies the requirements of the
downloads/medicaldevices/.../ Devices/DeviceRegulationandGuidance/
applicable statutes and regulations. This GuidanceDocuments/ucm085999.pdf.
ucm263366.pdf) and software that does guidance is not subject to Executive 2. ‘‘Suggested Format for Developing and
not meet the definition of a medical Order 12866. Responding to Deficiencies in
device at section 201(h) of the FD&C Act Accordance with the Least Burdensome
(21 U.S.C. 321(h)). III. Electronic Access
Provisions of FDAMA,’’ dated November
In the Federal Register on August 8, Persons interested in obtaining a copy 2, 2000, available at: https://
2016, FDA announced the availability of of the guidance may do so by www.fda.gov/downloads/Medical
the draft guidance and interested parties downloading an electronic copy from Devices/DeviceRegulationandGuidance/
were requested to comment by the internet. A search capability for all GuidanceDocuments/ucm073680.pdf.
November 7, 2016. FDA considered Center for Devices and Radiological Dated: October 20, 2017.
comments received on the draft Health guidance documents is available Leslie Kux,
guidance and revised the guidance as at https://www.fda.gov/MedicalDevices/ Associate Commissioner for Policy.
appropriate. DeviceRegulationandGuidance/ [FR Doc. 2017–23196 Filed 10–24–17; 8:45 am]
This guidance is not intended to GuidanceDocuments/default.htm.
BILLING CODE 4164–01–P
implement significant policy changes to Guidance documents are also available
FDA’s current thinking on when at https://www.fda.gov/BiologicsBlood
submission of a new 510(k) is required Vaccines/GuidanceCompliance DEPARTMENT OF HEALTH AND
for a software change to an existing RegulatoryInformation/Guidances/ HUMAN SERVICES
device. Rather, the intent of this default.htm or https://
guidance is to enhance the www.regulations.gov. Persons unable to Office of the Secretary
predictability, consistency, and download an electronic copy of
transparency of the ‘‘when to submit’’ ‘‘Deciding When to Submit a 510(k) for Notice of Interest Rate on Overdue
decision-making process by providing a a Software Change to an Existing Debts
least burdensome approach, and Device’’ may send an email request to
Section 30.18 of the Department of
describing in greater detail the CDRH-Guidance@fda.hhs.gov to receive
Health and Human Services’ claims
regulatory framework, policies, and an electronic copy of the document.
collection regulations (45 CFR part 30)
practices underlying such a decision, Please use the document number
provides that the Secretary shall charge
specifically as it relates to software 1500055 to identify the guidance you
an annual rate of interest, which is
changes. The recommendations are requesting.
determined and fixed by the Secretary
discussed in this guidance for IV. Paperwork Reduction Act of 1995 of the Treasury after considering private
evaluating when a software change to an This guidance refers to previously consumer rates of interest on the date
existing device would trigger the approved collections of information that the Department of Health and
requirement that a manufacturer submit found in FDA regulations. These Human Services becomes entitled to
a new 510(k) to the Agency are collections of information are subject to recovery. The rate cannot be lower than
consistent with the least burdensome review by the Office of Management and the Department of Treasury’s current
principles (Refs. 1 and 2). This guidance Budget (OMB) under the Paperwork value of funds rate or the applicable rate
applies the least burdensome principles, Reduction Act of 1995 (44 U.S.C. 3501– determined from the ‘‘Schedule of
in part, by reliance on risk management 3520). The collections of information in Certified Interest Rates with Range of
and the quality system regulation (21 21 CFR part 820 are approved under Maturities’’ unless the Secretary waives
CFR part 820) to determine whether OMB control number 0910–0073; the interest in whole or part, or a different
submission of a new 510(k) is required collections of information in 21 CFR rate is prescribed by statute, contract, or
for a software change to an existing part 807, subpart E are approved under repayment agreement. The Secretary of
device. OMB control number 0910–0120; the the Treasury may revise this rate
Elsewhere in this issue of the Federal collections of information in 21 CFR quarterly. The Department of Health and
Register, FDA is announcing the part 803 are approved under OMB Human Services publishes this rate in
availability of the guidance document control number 0910–0437; and the the Federal Register.
entitled ‘‘Deciding When to Submit a collections of information in 21 CFR The current rate of 93⁄4%, as fixed by
510(k) for a Change to an Existing parts 801 are approved under OMB the Secretary of the Treasury, is certified
Device,’’ to aid manufacturers of for the quarter ended September 30,
sradovich on DSK3GMQ082PROD with NOTICES
control number 0910–0485.
medical devices who intend to make 2017. This rate is based on the Interest
non-software changes to an existing V. References Rates for Specific Legislation, ‘‘National
device during the process of deciding The following references are on Health Services Corps Scholarship
whether the modification exceeds the display in the Dockets Management Program (42 U.S.C. 254o(b)(1)(A))’’ and
regulatory threshold of § 807.81(a)(3) for Staff (see ADDRESSES) and are available ‘‘National Research Service Award
submission and clearance of a new for viewing by interested persons Program (42 U.S.C. 288(c)(4)(B)).’’ This
510(k). between 9 a.m. and 4 p.m., Monday interest rate will be applied to overdue
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![Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49385
debt until the Department of Health and paragraph at the end of the section with pending further redelegations, provided
Human Services publishes a revision. the following: they are consistent with this
Dated: October 17, 2017. Office of Security and Strategic reorganization.
David C. Horn, Information (ABE) Eric D. Hargan,
Director, Office of Financial Policy and The Office of Security and Strategic Acting Secretary, Department of Health and
Reporting.
Information is headed by the Assistant Human Services.
[FR Doc. 2017–23092 Filed 10–24–17; 8:45 am] Deputy Secretary for National Security, [FR Doc. 2017–23091 Filed 10–24–17; 8:45 am]
BILLING CODE 4150–04–P who reports directly to the Deputy BILLING CODE 4151–17–P
Secretary and also serves as the
Secretary’s Senior Intelligence Official
DEPARTMENT OF HEALTH AND on intelligence and counterintelligence
HUMAN SERVICES DEPARTMENT OF HEALTH AND
issues. The Assistant Deputy Secretary HUMAN SERVICES
Office of the Secretary for National Security has been delegated
original classification authority by the National Institutes of Health
Office of the Assistant Secretary for Secretary. The Assistant Deputy
Administration; Statement of Secretary for National Security manages National Institute on Aging; Notice of
Organization, Functions, and the Office of Security and Strategic Closed Meeting
Delegations of Authority Information (OSSI). OSSI’s vision is for
HHS personnel to successfully Pursuant to section 10(d) of the
Part A, Office of the Secretary, accomplish missions worldwide in a Federal Advisory Committee Act, as
Statement of Organization, Functions, security-informed manner and with the amended, notice is hereby given of the
and Delegations of Authority for the actionable intelligence needed, at the following meeting.
Department of Health and Human right time, for operational and policy
Services (HHS) is being amended at Part decisions. OSSI’s responsibilities The meeting will be closed to the
A, Chapter AJ, Office of the Assistant include: Integrating intelligence and public in accordance with the
Secretary for Administration (ASA), security information into HHS policy provisions set forth in sections
which was last amended at 77 FR 2729, and operational decisions; assessing, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
dated January 19, 2012, and most anticipating, and warning of potential as amended. The grant applications and
recently at 77 FR 71004, dated security threats to the Department and the discussions could disclose
November 28, 2012. Part A, Chapter AB, our national security; and, providing confidential trade secrets or commercial
Section AB.20 a paragraph on Office of policy guidance on and managing the property such as patentable material,
Security and Strategic Information OS implementation of the Department’s and personal information concerning
(ABE), is being inserted. Part P, Program security, intelligence and individuals associated with the grant
Support Center (PSC), Statement of counterintelligence programs. OSSI’s applications, the disclosure of which
Organization, Functions, and programs include national security would constitute a clearly unwarranted
Delegations of Authority, which was last adjudication, classified national security invasion of personal privacy.
amended at 75 FR 369–370, dated information management, secure
Name of Committee: National Institute on
January 5, 2010, is not being amended. compartmented information facilities
Aging Special Emphasis Panel; Infrastructure
This notice transfers the onboarding/ management, communications security,
Development for Interdisciplinary Aging
suitability and physical security safeguarding and sharing of classified
Studies.
functions of the Office for Security and information, cyber threat intelligence,
Date: November 21, 2017.
Strategic Information (OSSI) to PSC. and counterintelligence. In coordination
Time: 12:00 p.m. to 3:00 p.m.
This transfer of functions complements with the Director of National
Agenda: To review and evaluate grant
the existing PSC component’s facilities Intelligence, OSSI has been designated
applications.
management functions, parking garage as a Federal Intelligence Coordinating
Place: National Institute on Aging,
entrance, safety-related programs, and Office and the Assistant Deputy
Gateway Building, Suite 2W200, 7201
other administrative functions. This Secretary for National Security serves as
Wisconsin Ave., Bethesda, MD 20892
notice also updates information the HHS Federal Senior Intelligence
(Telephone Conference Call).
regarding OSSI’s direct report to the Coordinator. OSSI has responsibilities
Contact Person: Isis S. Mikhail, MD, MPH,
Deputy Secretary, organizational to establish implementing guidance, DRPH, National Institute on Aging, Gateway
structure, as well as the new roles and provide oversight, and manage the Building, 7201 Wisconsin Avenue, Suite
responsibilities for the Assistant Deputy Department’s policy for the sharing, 2C212, Bethesda, MD 20892, 301–402–7704,
Secretary for National Security and safeguarding, and coordinated exchange MIKHAILI@MAIL.NIH.GOV.
Secretary’s Senior Intelligence Official of information related to national or
homeland security with other federal (Catalogue of Federal Domestic Assistance
and for OSSI. Program Nos. 93.866, Aging Research,
A. Part P, Program Support Center, departments and agencies, including
National Institutes of Health, HHS)
the statement of organization, functions, law enforcement organizations and the
and delegations of Authority therein Intelligence Community, in compliance Dated: October 19, 2017.
need not be changed as the transferred with HHS policies and applicable laws, Melanie J. Pantoja,
functions are within the scope of the regulations, and Executive Orders. Program Analyst, Office of Federal Advisory
E. Delegation of Authority. Pending
sradovich on DSK3GMQ082PROD with NOTICES
functions of PSC as described. Committee Policy.
B. Under Chapter AJ, Section AJ.20, further redelegation, directives or orders [FR Doc. 2017–23127 Filed 10–24–17; 8:45 am]
Functions, delete the last paragraph, made by the Secretary or Deputy
BILLING CODE 4140–01–P
which begins with ‘‘Office of Security Secretary, all delegations and
and Strategic Information (AJS),’’ in its redelegations of authority made to
entirety. officials and employees of affected
C. Under Chapter AB, Section AB.20, organizational components will
Functions, insert the following new continue in them or their successors
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Document Created: 2017-10-25 01:17:14
Document Modified: 2017-10-25 01:17:14
| 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 | |
| FR Citation | 82 FR 49384 |
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