61876 Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 

medical device enhancement. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Distinguishing Medical Device 

Recalls From Medical Device 

Enhancements,’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1819 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

The 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 7, subpart C, have been 

approved under OMB control number 

0910–0249; the collections of 

information in 21 CFR part 801 and 21 

CFR 809.10 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 803 have been approved under 

OMB control number 0910–0437; and 

the collections of information in 21 CFR 

part 810 have been approved under 

OMB control number 0910–0432. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24446 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1496] 

Regulatory Science Considerations for 

Software Used in Diabetes 

Management; Public Workshop; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing the following 

public workshop entitled ‘‘Regulatory 

Science Considerations for Software 

Used in Diabetes Management.’’ The 

goals of this public workshop are to 

foster greater stakeholder collaboration 

in the area of diabetes device 

interoperability and to seek input from 

the clinical community, academia, 

government, industry, and other 

stakeholders regarding usability 

considerations for appropriate 

information consumption (e.g., 

notifications, indicators, data, and 

displays) based on user skill and 

knowledge. The Agency also requests 

input regarding the technical 

considerations for insulin bolus 

calculator design and use. 

Date and Time: The public workshop 

will be held on November 13, 2014, 

from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993. 

Entrance for public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. Please arrive early to 

ensure time for parking and security 

screening. The public meeting will also 

be available to be viewed online via 

Webcast. 

Contact Persons: James Mullally, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5613, Silver Spring, MD 20993, 

240–402–5021, FAX: 301–847–8513, 

email: james.mullally@fda.hhs.gov; and 

Runa Musib, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5633, Silver Spring, 

MD 20993, 301–796–7014, FAX: 301– 

847–8513, email: runa.musib@

fda.hhs.gov. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. You must register online by 4 

p.m., November 6, 2014. Early 

registration is recommended because 

facilities are limited and, therefore, FDA 

may limit the number of participants 

from each organization. If time and 

space permit, onsite registration on the 

day of the public workshop will be 

provided beginning at 7 a.m. If you need 

special accommodations due to a 

disability, please contact Susan 

Monahan, 301–796–5661, email: 

susan.monahan@fda.hhs.gov, no later 

than October 30, 2014. 

To register for the public workshop, 

please visit FDA’s Medical Devices 

News & Events—Workshops & 

Conferences calendar at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm (select this public workshop 

from the posted events list). Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone number. Those without 

Internet access should contact Susan 

Monahan to register (see registration 

contact person). Registrants will receive 

confirmation after they have been 

accepted. You will be notified if you are 

on a waiting list. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be Webcast. Persons interested in 

viewing the Webcast must register 

online by 4 p.m., November 6, 2014. 

Early registration is recommended 

because Webcast connections are 

limited. Organizations are requested to 

register all participants, but to view 

using one connection per location. 

Webcast participants will be sent 

technical system requirements after 

registration and will be sent connection 

access information after November 6, 

2014. If you have never attended a 

Connect Pro event before, test your 

connection at https://

collaboration.fda.gov/common/help/en/

support/meeting_test.htm. To get a 

quick overview of the Connect Pro 

program, visit http://www.adobe.com/

go/connectpro_overview. (FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 61877 

sites after this document publishes in 

the Federal Register.) 

Requests for Oral Presentations: This 

public workshop includes a public 

comment session. During online 

registration you may indicate if you 

wish to speak during the public 

comment session and which topics you 

wish to address. FDA has included 

general topics in this document. FDA 

will do its best to accommodate requests 

to make public comments. Following 

the close of registration, FDA will 

determine the amount of time allotted to 

each speaker and will select and notify 

participants by November 10, 2014. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Comments: FDA is holding this public 

workshop to obtain input on insulin 

bolus calculators. In order to permit the 

widest possible opportunity to obtain 

public comment, FDA is soliciting 

either electronic or written comments 

regarding the public workshop topics 

that pertain to insulin bolus calculators. 

The deadline for submitting comments 

related to this public workshop is 

December 11, 2014. 

Regardless of attendance at the public 

workshop, interested persons may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Please identify comments with the 

docket number found in brackets in the 

heading of this document. In addition, 

when responding to specific questions 

as outlined in section II of this 

document, please identify the question 

number you are addressing. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. A link to the 

transcripts will also be available on the 

Internet at http://www.fda.gov/

MedicalDevices/NewsEvents/

WorkshopsConferences/default.htm 

(select this public workshop from the 

posted events list), approximately 45 

days after the workshop. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is seeking to foster greater 

stakeholder collaboration in the area of 

diabetes device interoperability. To that 

end, the Agency requests input from the 

clinical community, academia, 

government, industry, and other 

stakeholders regarding usability 

considerations for appropriate 

information consumption (e.g., 

notifications, indicators, data, and 

displays) based on user skill and 

knowledge. The Agency also requests 

input regarding the technical 

considerations for calculator design and 

use. 

The first topic of discussion is the 

interoperability between diabetes 

devices. The Agency recognizes that the 

diabetes community possesses an 

interest in patients having greater 

flexibility to pair device components, 

e.g., continuous glucose meters with 

insulin pumps from different 

manufacturers. Pairing would allow 

those devices to communicate with each 

other and enable patients to interact 

with a single interface platform. 

Achieving this goal would improve data 

tracking and access, thereby facilitating 

more productive patient interactions 

with their healthcare providers. In order 

to realize the objective of effective 

diabetes device interoperability, 

developers and manufacturers should 

discuss technical, safety, and regulatory 

challenges that lay before this goal. A 

forum that elicits opinions from 

physicians and patients regarding their 

desires and needs will help inform 

those discussions. FDA is committed to 

fostering a collaborative environment to 

promote these interactions. 

The second topic of discussion is 

insulin bolus calculators. These devices 

are intended to calculate insulin boluses 

for patients who manage their diabetes 

with insulin-intensive therapy. FDA 

currently regulates insulin bolus 

calculators as class II devices, often 

clearing them in combination with 

insulin pumps or blood glucose meters. 

Devices that calculate insulin boluses 

are increasingly available on the market, 

including those devices that use novel 

dosing algorithms and new user 

interface formats. Although these 

devices can benefit patient care, they 

could also jeopardize patient safety 

without proper regulation guarding 

against the serious health consequences 

of miscalculating insulin dosages. The 

Agency will host a public dialogue 

about insulin bolus calculators to help 

realize the aim of ensuring continued 

access to safe and effective 

technological innovations, regardless of 

interface format. 

The public workshop will include 

two sessions, one for each of the topics 

noted previously. Each session will 

include presentations from physicians, 

FDA, and other experts in the field. A 

panel discussion will follow the session 

addressing insulin bolus calculators, 

and the panel will address questions 

from the audience. In addition, Agency 

representatives will update the diabetes 

community on relevant FDA news. 

II. Topics for Discussion at the Public 

Workshop 

Among other topics, the workshop 

will include discussion of the following 

questions. 

1. How can patients and providers be 

confident that the insulin bolus values 

obtained from the calculators are 

accurate and appropriate for their use? 

2. What information do patients and 

providers need about how a particular 

calculator works so that they may 

appropriately use the calculator for 

diabetes management? 

3. How can FDA foster both 

innovation and safety of insulin dose 

calculators intended for use by 

healthcare practitioners? 

4. How can FDA foster both 

innovation and safety of insulin dose 

calculators intended for use by patients? 

Dated: October 8, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24451 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 209 and 37 CFR Part 404 to 

achieve expeditious commercialization 

of results of federally-funded research 

and development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 


tkelley on DSK3SPTVN1PROD with NOTICES