49384 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the draft guidance and interested parties 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). 

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 

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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

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 

paragraph at the end of the section with 

the following: 

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 

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 


sradovich on DSK3GMQ082PROD with NOTICES