82 FR 38691 - Supplemental Evidence and Data Request on Mobile Health Technology for Diabetes

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 156 (August 15, 2017)

Page Range		38691-38692
FR Document		2017-17152

The Agency for Healthcare Research and Quality is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Mobile Health Technology for Diabetes, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

Federal Register, Volume 82 Issue 156 (Tuesday, August 15, 2017)

[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Notices]
[Pages 38691-38692]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Mobile Health 
Technology for Diabetes

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality is seeking 
scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Mobile Health 
Technology for Diabetes, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before September 14, 2017.

ADDRESSES: 

Email submissions: src.org">[email protected]src.org.
Print submissions:
Mailing Address: Portland VA Research Foundation, Scientific Resource 
Center, ATTN: Scientific Information Packet Coordinator, P.O. Box 
69539, Portland, OR 97239
Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation,

[[Page 38692]]

Scientific Resource Center, ATTN: Scientific Information Packet 
Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, 
Portland, OR 97239

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">[email protected]src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality (AHRQ) has commissioned the Evidence-based Practice Centers 
(EPC) Program to complete a review of the evidence for Mobile Health 
Technology for Diabetes. AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Mobile Health Technology for Diabetes, including those 
that describe adverse events. The entire research protocol, including 
the key questions, is also available online at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2484.
    This is to notify the public that the EPC Program would find the 
following information on Mobile Health Technology for Diabetes helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. 
Materials submitted must be publicly available or able to be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Guiding Questions

    I. Which specific mobile health technology (mHealth) technologies 
for diabetes self-management have been researched?
    II. What are the characteristics (e.g., interoperability, 
functions, acceptability/usability, connection to electronic health 
records) of these specific mHealth technologies?
    III. What patient outcomes are associated with the use of these 
specific mHealth technologies?
    IV. What are the harms and costs associated with these specific 
mHealth technologies?

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-17152 Filed 8-14-17; 8:45 am]
BILLING CODE 4160-90-P

Federal Register / Vol. 82, No. 156 / Tuesday, August 15, 2017 / Notices 38691

Federal Communications Commission. FOR FURTHER INFORMATION CONTACT: For operator, or personnel delegated and
Marlene H. Dortch, additional information about the supervised by the chief operator, review
Secretary. information collection, contact Cathy the station records at least once each
[FR Doc. 2017–17131 Filed 8–14–17; 8:45 am] Williams at (202) 418–2918. week to determine if required entries are
BILLING CODE 6712–01–P SUPPLEMENTARY INFORMATION: As part of being made correctly, and verify that the
its continuing effort to reduce station has been operated in accordance
paperwork burdens, and as required by with FCC rules and the station
FEDERAL COMMUNICATIONS the PRA, 44 U.S.C. 3501–3520, the FCC authorization. Upon completion of the
COMMISSION invites the general public and other review, the chief operator must date and
Federal agencies to take this sign the log, initiate corrective action
[OMB 3060–0208] opportunity to comment on the which may be necessary and advise the
following information collections. station licensee of any condition which
Information Collection Being Reviewed Comments are requested concerning: is repetitive. The posting of the
by the Federal Communications Whether the proposed collection of designation of the chief operator is used
Commission information is necessary for the proper by interested parties to readily identify
performance of the functions of the the chief operator. The review of the
AGENCY: Federal Communications station records is used by the chief
Commission, including whether the
Commission. operator, and FCC staff in
information shall have practical utility;
ACTION: Notice and request for the accuracy of the Commission’s investigations, to ensure that the station
comments. burden estimate; ways to enhance the is operating in accordance with its
quality, utility, and clarity of the station authorization and the FCC rules
SUMMARY: As part of its continuing effort and regulations.
to reduce paperwork burdens, and as information collected; ways to minimize
required by the Paperwork Reduction the burden of the collection of Federal Communications Commission.
Act of 1995 (PRA), the Federal information on the respondents, Marlene H. Dortch,
Communications Commission (FCC or including the use of automated Secretary, Office of the Secretary.
Commission) invites the general public collection techniques or other forms of [FR Doc. 2017–17132 Filed 8–14–17; 8:45 am]
and other Federal agencies to take this information technology; and ways to
BILLING CODE 6712–01–P
opportunity to comment on the further reduce the information
following information collections. collection burden on small business
Comments are requested concerning: concerns with fewer than 25 employees.
OMB Control Number: 3060–0208. DEPARTMENT OF HEALTH AND
Whether the proposed collection of HUMAN SERVICES
information is necessary for the proper Title: Section 73.1870, Chief
performance of the functions of the Operators. Agency for Healthcare Research and
Commission, including whether the Form Number: Not applicable. Quality
information shall have practical utility; Type of Review: Extension of a
the accuracy of the Commission’s currently approved collection. Supplemental Evidence and Data
burden estimate; ways to enhance the Respondents: Business and other for- Request on Mobile Health Technology
quality, utility, and clarity of the profit; Not-for-profit institutions. for Diabetes
information collected; ways to minimize Number of Respondents and
Responses: 18,498 respondents; 36,996 AGENCY: Agency for Healthcare Research
the burden of the collection of and Quality, HHS.
information on the respondents, responses.
Estimated Time per Response: 0.166– ACTION: Request for supplemental
including the use of automated
26 hours. evidence and data submissions.
collection techniques or other forms of
information technology; and ways to Frequency of Response:
Recordkeeping requirement; Third party SUMMARY: The Agency for Healthcare
further reduce the information Research and Quality is seeking
collection burden on small business disclosure requirement.
Total Annual Burden: 484,019 hours. scientific information submissions from
concerns with fewer than 25 employees. the public. Scientific information is
The FCC may not conduct or sponsor Total Annual Cost: None.
Obligation to Respond: Required to being solicited to inform our review of
a collection of information unless it Mobile Health Technology for Diabetes,
displays a currently valid Office of obtain or retain benefits. The statutory
authority for this collection of which is currently being conducted by
Management and Budget (OMB) control the AHRQ’s Evidence-based Practice
number. No person shall be subject to information is contained in Sections
154(i) of the Communications Act of Centers (EPC) Program. Access to
any penalty for failing to comply with published and unpublished pertinent
a collection of information subject to the 1934, as amended.
Nature and Extent of Confidentiality: scientific information will improve the
PRA that does not display a valid OMB quality of this review.
control number. There is no need for confidentiality with
this collection of information. DATES: Submission Deadline on or
DATES: Written comments should be before September 14, 2017.
Privacy Impact Assessment(s): No
submitted on or before October 16, impact(s). ADDRESSES:
2017. If you anticipate that you will be Needs and Uses: The information Email submissions: SEADS@epc-src.org.
submitting comments, but find it collection requirements contained in 47 Print submissions:
mstockstill on DSK30JT082PROD with NOTICES

difficult to do so within the period of CFR 73.1870 require that the licensee of Mailing Address: Portland VA Research
time allowed by this notice, you should an AM, FM, or TV broadcast station Foundation, Scientific Resource
advise the contacts below as soon as designate a chief operator of the station. Center, ATTN: Scientific Information
possible. Section 73.1870(b)(3) requires that this Packet Coordinator, P.O. Box 69539,
ADDRESSES: Direct all PRA comments to designation must be in writing and Portland, OR 97239
Cathy Williams, FCC, via email: PRA@ posted with the station license. Section Shipping Address (FedEx, UPS, etc.):
fcc.gov and to Cathy.Williams@fcc.gov. 73.1870(c)(3) requires that the chief Portland VA Research Foundation,

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Document Created: 2017-08-15 01:12:49
Document Modified: 2017-08-15 01:12:49

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		Request for supplemental evidence and data submissions.
Dates		Submission Deadline on or before September 14, 2017.
Contact		Ryan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected]
FR Citation		82 FR 38691

82 FR 38691 - Supplemental Evidence and Data Request on Mobile Health Technology for Diabetes

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 82, Issue 156 (August 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality