83 FR 9857 - Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 46 (March 8, 2018)

Page Range		9857-9859
FR Document		2018-04629

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults.'' The topic to be discussed is the appropriate design of clinical studies to evaluate devices including digital health technologies intended for the diagnosis, monitoring, or treatment of sleep disordered breathing (SDB) in adults. Study design considerations to be discussed include definitions for SDB conditions, inclusion/exclusion criteria for studies of these conditions, use of SDB assessment technologies, controls, and study endpoints.

Federal Register, Volume 83 Issue 46 (Thursday, March 8, 2018)

[Federal Register Volume 83, Number 46 (Thursday, March 8, 2018)]
[Notices]
[Pages 9857-9859]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04629]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0756]


Study Design Considerations for Devices Including Digital Health 
Technologies for Sleep Disordered Breathing in Adults; Public Workshop; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Study Design 
Considerations for Devices including Digital Health Technologies for 
Sleep Disordered Breathing in Adults.'' The topic to be discussed is 
the appropriate design of clinical studies to evaluate devices 
including digital health technologies intended for the diagnosis, 
monitoring, or treatment of sleep disordered breathing (SDB) in adults. 
Study design considerations to be discussed include definitions for SDB 
conditions, inclusion/exclusion criteria for studies of these 
conditions, use of SDB assessment technologies, controls, and study 
endpoints.

DATES: The public workshop will be held on April 16, 2018, from 8 a.m. 
to 5 p.m. Submit either electronic or written comments on this public 
workshop by April 30, 2018. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

[[Page 9858]]

    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before April 30, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end April 30, 2018. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-0756 for ``Study Design Considerations for Devices including 
Digital Health Technologies for Sleep Disordered Breathing in Adults; 
Public Workshop; Request for Comments.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sageev George, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2443, Silver Spring, MD 20993, 301-796-6468, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Over the past several years, FDA has seen a marked increase in 
premarket submissions for devices intended for both the diagnosis and 
treatment of SDB. These include novel technologies for in-home 
assessment, intra-oral appliances, externally worn devices that 
generate increased upper airway pressures, passive implants, active 
implantable devices that stimulate the upper airway neuromusculature, 
and mobile apps for assessing and monitoring sleep. The large variety 
of technologies often poses different and challenging questions of 
safety and effectiveness and differing benefit-risk profiles for these 
devices. We have planned this workshop to bring together device 
regulators, clinical experts in sleep medicine, patients, and other 
stakeholders to discuss these challenges and potential solutions. The 
goal is to expedite innovation in SDB devices including digital health 
technologies and make sure that patients have timely access to 
reasonably safe and effective devices. To this end, we are actively 
seeking input and participation from several professional societies and 
patient advocacy groups with interests in the field of SDB.

II. Topics for Discussion at the Public Workshop

    The topics to be discussed are the appropriate design of clinical 
studies to evaluate devices and digital health technologies intended 
for the diagnosis, monitoring, or treatment of SDB in adults. Study 
design considerations to be discussed include definitions for SDB 
conditions, inclusion/exclusion criteria for studies of these 
conditions, use of SDB assessment technologies (e.g., polysomnography, 
home sleep studies), controls, and study endpoints.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit 
FDA's Medical Devices News & Events--Workshops & Conferences calendar 
at https://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.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by April 9, 2018, by 4 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive

[[Page 9859]]

confirmation when they have been accepted. If time and space permit, 
onsite registration on the day of the public workshop will be provided 
beginning at 7:30 a.m. We will let registrants know if registration 
closes before the day of the public workshop.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
[email protected], no later than April 9, 2018.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. The webcast link will be available on the registration 
web page after April 9, 2018. Organizations are requested to register 
all participants, but to view using one connection per location.
    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 https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available 
approximately 45 days after the public workshop on the internet at 
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

    Dated: March 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04629 Filed 3-7-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 46 / Thursday, March 8, 2018 / Notices 9857

‘‘Collection of information’’ is defined assumptions used; (3) ways to enhance regulations authorizes a health claim for
in 44 U.S.C. 3502(3) and 5 CFR the quality, utility, and clarity of the food labels about soy protein and the
1320.3(c) and includes Agency requests information to be collected; and (4) risk of coronary heart disease (CHD).
or requirements that members of the ways to minimize the burden of the Accordingly, FDA established the
public submit reports, keep records, or collection of information on previously referenced information
provide information to a third party. respondents, including through the use collection in support of the regulation.
Section 3506(c)(2)(A) of the PRA (44 of automated collection techniques, In the Federal Register of October 31,
U.S.C. 3506(c)(2)(A)) requires Federal when appropriate, and other forms of 2017 (82 FR 50324), we published a
Agencies to provide a 60-day notice in information technology. proposed rule to revoke the underlying
the Federal Register concerning each regulation found at 21 CFR 101.82. We
proposed collection of information, Record Retention Requirements for the are taking this action based on our
including each proposed extension of an Soy Protein and Risk of Coronary Heart review of the totality of publicly
existing collection of information, Disease Health Claim—21 CFR 101.82 available scientific evidence currently
before submitting the collection to OMB OMB Control Number 0910–0428— available and our tentative conclusion
for approval. To comply with this Extension that such evidence does not support our
requirement, FDA is publishing notice previous determination that there is
of the proposed collection of Section 403(r)(3)(A) of the Federal significant scientific agreement (SSA)
information set forth in this document. Food, Drug, and Cosmetic Act (21 U.S.C. among qualified experts for a health
With respect to the following 343(r)(3)(A)) provides for the use of food claim regarding the relationship
collection of information, FDA invites label statements characterizing a between soy protein and reduced risk of
comments on these topics: (1) Whether relationship of any nutrient of the type coronary heart disease. Upon
the proposed collection of information required to be in the label or labeling of finalization of the proposed rule the
is necessary for the proper performance the food to a disease or a health related associated information collection
of FDA’s functions, including whether condition only where that statement requirements under this OMB Control
the information will have practical meets the requirements of the Number will be revoked. Until such
utility; (2) the accuracy of FDA’s regulations issued by the Secretary of time and in accordance with the PRA
estimate of the burden of the proposed Health and Human Services to authorize we retain our currently approved
collection of information, including the the use of such a health claim. Section burden estimate for the information
validity of the methodology and 101.82 (21 CFR 101.82) of our collection as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeping recordkeeping

101.82(c)(2)(ii)(B) ................................................................. 25 1 25 1 25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based upon our current experience DEPARTMENT OF HEALTH AND disordered breathing (SDB) in adults.
with the use of health claims, we HUMAN SERVICES Study design considerations to be
estimate 25 firms market products discussed include definitions for SDB
bearing a soy protein/coronary heart Food and Drug Administration conditions, inclusion/exclusion criteria
disease health claim and that perhaps for studies of these conditions, use of
[Docket No. FDA–2018–N–0756] SDB assessment technologies, controls,
one of each firm’s products might
contain non-soy sources of protein along Study Design Considerations for and study endpoints.
with soy protein. The records currently Devices Including Digital Health DATES: The public workshop will be
required to be retained under Technologies for Sleep Disordered held on April 16, 2018, from 8 a.m. to
§ 101.82(c)(2)(ii)(B) are the records, e.g., Breathing in Adults; Public Workshop; 5 p.m. Submit either electronic or
the formulation or recipe, that a Request for Comments written comments on this public
manufacturer has and maintains as a workshop by April 30, 2018. See the
AGENCY: Food and Drug Administration,
normal course of its doing business. SUPPLEMENTARY INFORMATION section for
HHS.
Thus, the burden to the food registration date and information.
manufacturer is limited to assembling ACTION: Notice of public workshop;
request for comments. ADDRESSES: The public workshop will
and retaining the records, which we be held at FDA’s White Oak Campus,
estimate will take 1 hour annually. SUMMARY: The Food and Drug 10903 New Hampshire Ave., Bldg. 31
Dated: February 28, 2018. Administration (FDA, the Agency, or Conference Center, the Great Room (Rm.
Leslie Kux, we) is announcing the following public 1503), Silver Spring, MD 20993.
Associate Commissioner for Policy.
workshop entitled ‘‘Study Design Entrance for the public workshop
Considerations for Devices including participants (non-FDA employees) is
sradovich on DSK3GMQ082PROD with NOTICES

[FR Doc. 2018–04630 Filed 3–7–18; 8:45 am]
Digital Health Technologies for Sleep through Building 1 where routine
BILLING CODE 4164–01–P Disordered Breathing in Adults.’’ The security check procedures will be
topic to be discussed is the appropriate performed. For parking and security
design of clinical studies to evaluate information, please refer to https://
devices including digital health www.fda.gov/AboutFDA/Workingat
technologies intended for the diagnosis, FDA/BuildingsandFacilities/WhiteOak
monitoring, or treatment of sleep CampusInformation/ucm241740.htm.

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Federal Register / Vol. 83, No. 46 / Thursday, March 8, 2018 / Notices 9859

confirmation when they have been SUMMARY: This notice fulfills obligations c. Create a timeline, which may also
accepted. If time and space permit, under section 3002 of the Public Health account for the National Institute of
onsite registration on the day of the Service Act (PHSA), as amended by the Standards and Technology (NIST)
public workshop will be provided 21st Century Cures Act. Section 3002(b) testing, where appropriate, and include
beginning at 7:30 a.m. We will let (5) of the PHSA, as amended, mandates dates when the HITAC is expected to
registrants know if registration closes that the Health Information Technology issue the recommendation to the
before the day of the public workshop. Advisory Committee shall develop a National Coordinator.
If you need special accommodations schedule for the assessment of policy d. Include an opportunity for public
due to a disability, please contact Susan recommendations and the Secretary comment during the consideration by
Monahan, Center for Devices and shall publish such schedule in the the HITAC of the request by the
Radiological Health, Food and Drug Federal Register. National Coordinator for
Administration, 10903 New Hampshire FOR FURTHER INFORMATION CONTACT: recommendations on a matter.
Ave., Bldg. 32, Rm. 5231, Silver Spring, Lauren Richie Designated Federal 2. In responding to the National
MD 20993–0002, 301–796–5661, email: Officer, at Lauren.Richie@hhs.gov. Coordinator:
Susan.Monahan@fda.hhs.gov, no later SUPPLEMENTARY INFORMATION: Section a. Approve a timeline to deliver
than April 9, 2018. 3002 of the Public Health Service Act recommendations to the National
Streaming Webcast of the Public Coordinator; and
(PHSA), as amended by the 21st Century
Workshop: This public workshop will b. Establish a task force to conduct
Cures Act (Pub. L. 114–255), establishes
also be webcast. The webcast link will analysis and solicit input, where
the Health Information Technology
be available on the registration web page appropriate, and develop draft
Advisory Committee (HITAC). The
after April 9, 2018. Organizations are recommendations to be considered by
HITAC will be governed by the
requested to register all participants, but the full committee in a timely manner.
provisions of the Federal Advisory
to view using one connection per 3. In collaboration with NIST,
Committee Act (Pub. L. 92–463), as
location. annually and through the use of public
If you have never attended a Connect amended (5 U.S.C. App.), which sets
forth standards for the formation and input, review and publish priorities for
Pro event before, test your connection at the use of health information
https://collaboration.fda.gov/common/ use of federal advisory committees. The
HITAC, among other things, shall technology, standards, and
help/en/support/meeting_test.htm. To implementation specifications to
get a quick overview of the Connect Pro identify priorities for standards
adoption and make recommendations to support those priorities.
program, visit https://www.adobe.com/ 4. Recommend to the National
go/connectpro_overview. FDA has the National Coordinator for Health
Information Technology (National Coordinator for purposes of adoption
verified the website addresses in this under section 3004, standards,
document, as of the date this document Coordinator) on a policy framework to
advance an interoperable health implementation specifications, and
publishes in the Federal Register, but certification criteria and an order of
websites are subject to change over time. information technology infrastructure.
priority for the development,
Transcripts: Please be advised that as Health Information Technology harmonization, and recognition of such
soon as a transcript of the public Advisory Committee Schedule standards, specifications, and
workshop is available, it will be certification criteria. Such
accessible at https:// Section 3002(b)(5) of the PHSA, as
amended, provides that the HITAC shall recommendations shall include
www.regulations.gov. It may be viewed recommended standards, architectures,
at the Dockets Management Staff (see develop a schedule for the assessment of
policy recommendations developed by and software schemes for access to
ADDRESSES). A link to the transcript will
the HITAC and publish the schedule in electronic individually identifiable
also be available approximately 45 days health information across disparate
after the public workshop on the the Federal Register. This schedule
addresses the assessment of systems including user vetting,
internet at https://www.fda.gov/Medical authentication, privilege management,
Devices/NewsEvents/Workshops recommendations outlined in the policy
framework recommended by the HITAC and access control.
Conferences/default.htm. (Select this The topics in which the HITAC is
public workshop from the posted events to the National Coordinator.
Accordingly, the schedule for the expected to address in FY2018 include,
list.) but may not be limited to the target
HITAC’s assessment of policy
Dated: March 2, 2018. recommendations is as follows: areas as defined in section 3002 of the
Leslie Kux, 1. Within 90 days of a charge by the PHSA, as amended by the 21st Century
Associate Commissioner for Policy. National Coordinator for Cures Act (Pub. L. 114–255), and they
[FR Doc. 2018–04629 Filed 3–7–18; 8:45 am] recommendations on a matter, identify include:
BILLING CODE 4164–01–P the best mechanism to organize itself to 1. Achieving a health information
develop recommendations, and at a technology infrastructure that allows for
minimum, will: the electronic access, exchange, and use
DEPARTMENT OF HEALTH AND a. Develop an assessment of what of health information ;
HUMAN SERVICES policies, standards, implementation 2. The promotion and protection of
specifications, and certification criteria privacy and security of health
Health Information Technology are currently available to be considered information in health information
Advisory Committee 2018 Schedule as part of the request; technology;
sradovich on DSK3GMQ082PROD with NOTICES

AGENCY: Office of the National b. Consider where gaps exist and 3. The facilitation of secure access by
Coordinator for Health Information identify potential organizations that an individual to such individual’s
Technology (ONC), HHS. have the capability to address those protected health information; and
gaps (i.e., no policy or standard is 4. Any other target area that the
ACTION: Notice of the Health Information
available or harmonization is required HITAC identifies as an appropriate
Technology Advisory Committee 2018
because more than one standard exists) target area to be considered. [42USC
schedule.
related to the request; and § 300jj (b)(2)(B)]

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Document Created: 2018-03-08 01:47:45
Document Modified: 2018-03-08 01:47:45

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
Action		Notice of public workshop; request for comments.
Dates		The public workshop will be held on April 16, 2018, from 8 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by April 30, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Contact		Sageev George, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2443, Silver Spring, MD 20993, 301-796-6468, [email protected]
FR Citation		83 FR 9857

83 FR 9857 - Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 46 (March 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration