82_FR_14788 82 FR 14734 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

82 FR 14734 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 82, Issue 54 (March 22, 2017)

Page Range14734-14735
FR Document2017-05627

In compliance with the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0955-0009 which expires on May 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Federal Register, Volume 82 Issue 54 (Wednesday, March 22, 2017)
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Pages 14734-14735]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05627]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: 0955-0009-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Secretary, HHS.

[[Page 14735]]


ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
Office of the Secretary (OS), Department of Health and Human Services, 
announces plans to submit an Information Collection Request (ICR), 
described below, to the Office of Management and Budget (OMB). The ICR 
is for extending the use of the approved information collection 
assigned OMB control number 0955-0009 which expires on May 31, 2017. 
Prior to submitting the ICR to OMB, OS seeks comments from the public 
regarding the burden estimate, below, or any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before May 22, 2017.

ADDRESSES: Submit your comments to 
[email protected] or by calling (202) 690-5683.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the document identifier 0955-0009-60D for 
reference.
    Information Collection Request Title: Customer Relationship 
Management (CRM) Tool.
    OMB No.: 0955-0009.
    Abstract: The Customer Relationship Management (CRM) application is 
a nimble business intelligence tool being used by more than 1,500 users 
at ONC partner organizations and grantees. The CRM collects data from a 
large number of users throughout the United States who are ``on the 
ground'' helping healthcare providers adopt and optimize their IT 
systems, it provides near real-time data about the adoption, 
utilization, and meaningful use of EHR technology. Approximately half 
of all Primary Care Providers in the nation are represented in the CRM 
tool; data points include provider location, credential, specialty, 
whether live on an EHR and what system, whether they've reached MU, the 
time between these, and narrative barriers experienced by many of 
these.
    Need and Proposed Use of the Information: The CRM tool supplements 
and is regularly merged with other data sources both within and outside 
of HHS and tracks program performance and progress towards milestones. 
Combined with ONC's internal analytical capacity, this data provides 
feedback that goes beyond anecdotal evidence and can be turned into 
tangible lessons learned that are used to focus policy and program 
efforts and ultimately achieve concrete outcomes.
    Likely Respondents: HITECH Grantees.
    The total annual burden hours estimated for this ICR are summarized 
in the table below.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                    Form name                        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
CRM Tool--Workforce.............................               7             125             1.5           1,313
CRM Tool--Advance Interoperable HIE Program.....              24              24             1.5             864
CRM Tool--CHP/Academy Health....................               1              12             1.5              18
                                                 ---------------------------------------------------------------
    Total.......................................              32             161             4.5           2,195
----------------------------------------------------------------------------------------------------------------

    OS specifically requests comments on (1) the necessity and utility 
of the proposed information collection for the proper performance of 
the agency's functions, (2) the accuracy of the estimated burden, (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected, and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.

Terry S. Clark,
Asst. Information Collection Clearance Officer.
[FR Doc. 2017-05627 Filed 3-21-17; 8:45 am]
 BILLING CODE 4150-45-P



                                                    14734                       Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Notices

                                                       The Draft EA evaluates the potential                 DEPARTMENT OF HEALTH AND                              Program. It will provide up-to-date
                                                    environmental impacts that may result                   HUMAN SERVICES                                        information on program progress and
                                                    from the Proposed Action (referred to as                                                                      current initiatives and present a high-
                                                    the Build Alternative) and the No Build                 Food and Drug Administration                          level regulatory overview of the
                                                    Alternative on the natural and built                    [Docket No. FDA–2017–N–0001]                          complete ANDA review pathway.
                                                    environment. Potential impacts of each                                                                        III. Participating in the Public
                                                    alternative are evaluated on the                        Food and Drug Administration Center                   Conference
                                                    following resource categories:                          for Drug Evaluation and Research
                                                                                                            Small Business and Industry                              Registration: There is no fee to attend
                                                    Socioeconomics; land use; zoning;                                                                             the public conference. Space is limited,
                                                    public policy; community facilities;                    Assistance Regulatory Education for
                                                                                                            Industry Generic Drugs Forum; Public                  and registration will be on a first-come,
                                                    transportation; air quality; noise;                                                                           first-served basis. To register, please
                                                    cultural resources; urban design and                    Conference
                                                                                                                                                                  complete registration online at: https://
                                                    visual resources; natural resources;                    AGENCY:    Food and Drug Administration,              www.fda.gov/Drugs/
                                                    utilities; waste; and greenhouse gases                  HHS.                                                  DevelopmentApprovalProcess/
                                                    and sustainability. The Draft EA                        ACTION:   Notice of public conference.                SmallBusinessAssistance/
                                                    identifies measures to mitigate potential                                                                     ucm540969.htm?utm_
                                                    adverse impacts.                                        SUMMARY:    The Food and Drug                         source=FRN&utm_campaign=GDF2017.
                                                       Availability of the Draft EA: Copies of              Administration (FDA) Center for Drug                  Early registration is recommended.
                                                    the Draft EA have been distributed to                   Evaluation and Research (CDER) is                     Registrants will receive email
                                                                                                            sponsoring a 2-day public conference                  confirmation when they have been
                                                    Federal, State, and local agencies and
                                                                                                            entitled ‘‘FDA CDER Small Business                    accepted, and reminder emails will be
                                                    organizations. The Draft EA is available
                                                                                                            and Industry Assistance (SBIA)                        sent to registrants 2 days before the
                                                    online in the Federal eRulemaking
                                                                                                            Regulatory Education for Industry                     conference. If time and space permit,
                                                    Portal at www.regulations.gov,                          (REdI) Generic Drugs Forum.’’ The goal                onsite registration will be available
                                                    identified by Docket No. CDC–2017–                      of this public conference is to provide               beginning at 7:30 a.m. on each day of
                                                    0019. Copies of the Draft EA are also                   direct, relevant, and helpful information             the public conference.
                                                    available at:                                           on the key aspects of the generic drug                   If you need special accommodations
                                                       D Chamblee Public Library, 4115                      development process. Our primary                      due to disability, please contact info@
                                                    Clairmont Road, Chamblee GA 30341,                      audience is that of small manufacturers               sbiaevents.com at least 7 days in
                                                    Telephone: (770) 936–1380.                              within the generic drug industry.                     advance.
                                                                                                            However, anyone involved in the                          Streaming Webcast of the Public
                                                       D Doraville Public Library, 3748                                                                           Conference: This public conference will
                                                                                                            pharmaceutical industry may attend.
                                                    Central Ave, Doraville, GA 30340,                                                                             also be webcast. Persons interested in
                                                    Telephone: (770) 936–3852.                              DATES: The public conference will be
                                                                                                            held April 4–5, 2017, from 8:30 a.m. to               viewing the webcast must register to
                                                       D Brookhaven Branch Public Library,                  4:30 p.m. See the SUPPLEMENTARY                       receive a confirmation email with the
                                                    1242 N. Druid Hills Rd NE., Atlanta, GA                 INFORMATION section for registration                  webcast link.
                                                    30319, Telephone: (404) 848–7140.                       information.                                             If you have never attended a Connect
                                                                                                                                                                  Pro event before, test your connection at
                                                       D Chamblee City Hall, 5468 Peachtree                 ADDRESSES:   The public conference will               https://collaboration.fda.gov/common/
                                                    Road, Chamblee, GA 30341, Telephone:                    be held in the Pinnacle Ballroom                      help/en/support/meeting_test.htm. To
                                                    (770) 986–5010.                                         located on the 2nd floor of DoubleTree                get a quick overview of the Connect Pro
                                                       Paper and electronic copies can also                 by Hilton Hotel, 8727 Colesville Rd.,                 program, visit https://www.adobe.com/
                                                    be requested as instructed in the                       Silver Spring, MD 20910.                              go/connectpro_overview. FDA has
                                                    ADDRESSES section of this document.                     FOR FURTHER INFORMATION CONTACT:                      verified the Web site addresses in this
                                                       Public Meeting: A public meeting will                Brenda Stodart, Center for Drug                       document, as of the date this document
                                                    be held on Wednesday, April 19, 2017                    Evaluation and Research, Food and                     publishes in the Federal Register, but
                                                    at 2400 Century Center, Century Pkwy.                   Drug Administration, 10001 New                        Web sites are subject to change over
                                                    NE., Atlanta, Georgia 30345. The public                 Hampshire Ave., Silver Spring, MD                     time.
                                                                                                            20993–0002, 301–796–6707, email:                         Transcripts: Transcripts will not be
                                                    meeting will consist of an Open House
                                                                                                            cdersbia@fda.hhs.gov.                                 available.
                                                    from 6:00 p.m. to 8:00 p.m. EDT. The
                                                                                                            SUPPLEMENTARY INFORMATION:                              Dated: March 16, 2017.
                                                    meeting will be an open house where
                                                    attendees can learn more about the                      I. Background                                         Leslie Kux,
                                                    Master Plan and Draft EA, ask questions,                                                                      Associate Commissioner for Policy.
                                                                                                              FDA is announcing a public
                                                    and submit comments in writing.                                                                               [FR Doc. 2017–05602 Filed 3–21–17; 8:45 am]
                                                                                                            conference entitled ‘‘FDA CDER Small
                                                                                                                                                                  BILLING CODE 4164–01–P
                                                      Dated: March 15, 2017.                                Business and Industry Assistance
                                                    Sandra Cashman,                                         Regulatory Education for Industry
                                                    Executive Secretary, Centers for Disease                Generic Drugs Forum.’’ This public                    DEPARTMENT OF HEALTH AND
                                                    Control and Prevention.                                 conference is intended to increase the                HUMAN SERVICES
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                                                    [FR Doc. 2017–05624 Filed 3–21–17; 8:45 am]
                                                                                                            generic drug industry’s awareness of
                                                                                                            applicable FDA regulations.                           Office of the Secretary
                                                    BILLING CODE 4163–18–P
                                                                                                            II. Topics for Discussion at the Public               [Document Identifier: 0955–0009–60D]
                                                                                                            Conference
                                                                                                                                                                  Agency Information Collection
                                                                                                              This 2-day, FDA-led forum offers the
                                                                                                                                                                  Activities; Proposed Collection; Public
                                                                                                            opportunity to interact with FDA
                                                                                                                                                                  Comment Request
                                                                                                            subject matter experts from across CDER
                                                                                                            involved in the Generic Drug Review                   AGENCY:   Office of the Secretary, HHS.


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                                                                                                Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Notices                                                                                       14735

                                                    ACTION:        Notice.                                                                 SUPPLEMENTARY INFORMATION:     When                                          include provider location, credential,
                                                                                                                                           submitting comments or requesting                                            specialty, whether live on an EHR and
                                                    SUMMARY:   In compliance with the                                                      information, please include the                                              what system, whether they’ve reached
                                                    Paperwork Reduction Act of 1995, the                                                   document identifier 0955–0009–60D for                                        MU, the time between these, and
                                                    Office of the Secretary (OS), Department                                               reference.                                                                   narrative barriers experienced by many
                                                    of Health and Human Services,                                                            Information Collection Request Title:                                      of these.
                                                    announces plans to submit an                                                           Customer Relationship Management                                                Need and Proposed Use of the
                                                    Information Collection Request (ICR),                                                  (CRM) Tool.                                                                  Information: The CRM tool supplements
                                                    described below, to the Office of                                                        OMB No.: 0955–0009.                                                        and is regularly merged with other data
                                                    Management and Budget (OMB). The                                                         Abstract: The Customer Relationship                                        sources both within and outside of HHS
                                                    ICR is for extending the use of the                                                    Management (CRM) application is a                                            and tracks program performance and
                                                    approved information collection                                                        nimble business intelligence tool being                                      progress towards milestones. Combined
                                                    assigned OMB control number 0955–                                                      used by more than 1,500 users at ONC                                         with ONC’s internal analytical capacity,
                                                    0009 which expires on May 31, 2017.                                                    partner organizations and grantees. The                                      this data provides feedback that goes
                                                    Prior to submitting the ICR to OMB, OS                                                 CRM collects data from a large number                                        beyond anecdotal evidence and can be
                                                    seeks comments from the public                                                         of users throughout the United States                                        turned into tangible lessons learned that
                                                    regarding the burden estimate, below, or                                               who are ‘‘on the ground’’ helping                                            are used to focus policy and program
                                                    any other aspect of the ICR.                                                           healthcare providers adopt and optimize                                      efforts and ultimately achieve concrete
                                                                                                                                           their IT systems, it provides near real-                                     outcomes.
                                                    DATES: Comments on the ICR must be
                                                                                                                                           time data about the adoption,                                                   Likely Respondents: HITECH
                                                    received on or before May 22, 2017.
                                                                                                                                           utilization, and meaningful use of EHR                                       Grantees.
                                                    ADDRESSES:  Submit your comments to                                                    technology. Approximately half of all                                           The total annual burden hours
                                                    Information.CollectionClearance@                                                       Primary Care Providers in the nation are                                     estimated for this ICR are summarized
                                                    hhs.gov or by calling (202) 690–5683.                                                  represented in the CRM tool; data points                                     in the table below.
                                                                                                                                TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                                                               Average
                                                                                                                                                                                                                               Number of
                                                                                                                                                                                                               Number of                     burden per     Total burden
                                                                                                                     Form name                                                                                               responses per
                                                                                                                                                                                                              respondents                     response         hours
                                                                                                                                                                                                                               respondent     (in hours)

                                                    CRM Tool—Workforce ......................................................................................................................                            7            125             1.5          1,313
                                                    CRM Tool—Advance Interoperable HIE Program ............................................................................                                             24             24             1.5            864
                                                    CRM Tool—CHP/Academy Health ...................................................................................................                                      1             12             1.5             18

                                                          Total ...........................................................................................................................................             32            161             4.5          2,195



                                                      OS specifically requests comments on                                                 SUMMARY:    As stipulated by the Federal                                     purpose of the CFSAC is to provide
                                                    (1) the necessity and utility of the                                                   Advisory Committee Act, the U.S.                                             advice and recommendations to the
                                                    proposed information collection for the                                                Department of Health and Human                                               Secretary of Health and Human Services
                                                    proper performance of the agency’s                                                     Services (DHHS) is hereby giving notice                                      (HHS), through the Assistant Secretary
                                                    functions, (2) the accuracy of the                                                     that a webinar meeting of the Chronic                                        for Health (ASH), on issues related to
                                                    estimated burden, (3) ways to enhance                                                  Fatigue Syndrome Advisory Committee                                          myalgic encephalomyelitis/chronic
                                                    the quality, utility, and clarity of the                                               (CFSAC) will take place and will be                                          fatigue syndrome (ME/CFS). The issues
                                                    information to be collected, and (4) the                                               open to the general public to listen in                                      can include factors affecting access and
                                                    use of automated collection techniques                                                 via a toll free number.                                                      care for persons with ME/CFS; the
                                                    or other forms of information                                                          DATES: The CFSAC webinar will be held                                        science and definition of ME/CFS; and
                                                    technology to minimize the information                                                 on Thursday, June 29, 2017, from 12                                          broader public health, clinical, research,
                                                    collection burden.                                                                     p.m. until 5 p.m. (EST) and on Friday,                                       and educational issues related to
                                                                                                                                           June 30, 2017 from 9 a.m. to 5 p.m.                                          ME/CFS.
                                                    Terry S. Clark,                                                                                                                                                        The agenda for this meeting, call-in
                                                                                                                                           ADDRESSES: This meeting will be
                                                    Asst. Information Collection Clearance                                                                                                                              information and location will be posted
                                                    Officer.
                                                                                                                                           broadcasted to the public as a webinar.
                                                                                                                                           A webinar is a virtual meeting.                                              on the CFSAC Web site http://
                                                    [FR Doc. 2017–05627 Filed 3–21–17; 8:45 am]
                                                                                                                                           Registration is not required for the                                         www.hhs.gov/ash/advisory-committees/
                                                    BILLING CODE 4150–45–P
                                                                                                                                           webinar.                                                                     cfsac/meetings/index.html.
                                                                                                                                                                                                                           A half hour of public comment via
                                                                                                                                           FOR FURTHER INFORMATION CONTACT:                                             telephone will be scheduled for the first
                                                    DEPARTMENT OF HEALTH AND                                                               Gustavo Seinos, MPH, Designated                                              half day of the webinar and an entire
                                                    HUMAN SERVICES                                                                         Federal Officer, Chronic Fatigue                                             hour for the second day of the webinar.
                                                                                                                                           Syndrome Advisory Committee,                                                 Individuals will have five minutes to
                                                    Meeting of the Chronic Fatigue                                                         Department of Health and Human                                               present their comments. Priority will be
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                                                    Syndrome Advisory Committee                                                            Services, 200 Independence Avenue                                            given to individuals who have not
                                                                                                                                           SW., Room 728F.6, Washington, DC                                             provided public comment within the
                                                    AGENCY:  Office of the Assistant                                                       20201. Please direct all inquiries to                                        previous year. We are unable to place
                                                    Secretary for Health, Office of the                                                    cfsac@hhs.gov.                                                               international calls for public comments.
                                                    Secretary, Department of Health and                                                    SUPPLEMENTARY INFORMATION: The                                               To request a time slot for public
                                                    Human Services.                                                                        CFSAC is authorized under 42                                                 comment, please send an email to
                                                    ACTION:        Notice.                                                                 U.S.C.217a, Section 222 of the Public                                        cfsac@hhs.gov by June 1, 2017. The
                                                                                                                                           Health Service Act, as amended. The                                          email should contain the speaker’s


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Document Created: 2017-03-22 03:58:47
Document Modified: 2017-03-22 03:58:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on the ICR must be received on or before May 22, 2017.
FR Citation82 FR 14734 

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