82_FR_57690 82 FR 57458 - Agency Information Collection Activities; Proposed Collection; Public Comments Request; New Data Collection; National Center on Law and Elder Rights (NCLER)

82 FR 57458 - Agency Information Collection Activities; Proposed Collection; Public Comments Request; New Data Collection; National Center on Law and Elder Rights (NCLER)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living

Federal Register Volume 82, Issue 232 (December 5, 2017)

Page Range57458-57460
FR Document2017-26116

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from legal and aging/disability service professionals. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of Information and to allow 60 days for public comment in response on the proposed action. This notice solicits comments on proposed information collection requirements relating to ACL funded training, case consultation, and technical assistance for aging/disability networks assisting older adults in social or economic need facing legal issues.

Federal Register, Volume 82 Issue 232 (Tuesday, December 5, 2017)
[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Notices]
[Pages 57458-57460]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26116]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living


Agency Information Collection Activities; Proposed Collection; 
Public Comments Request; New Data Collection; National Center on Law 
and Elder Rights (NCLER)

AGENCY: Administration for Community Living, HHS.

ACTION: Notice.

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

SUMMARY: The Administration for Community Living (ACL) is announcing an 
opportunity for the public to comment on ACL's intention to collect 
information from legal and aging/disability service professionals. 
Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies 
are required to publish a notice in the Federal Register concerning 
each proposed collection of Information and to allow 60 days for public 
comment in response on the proposed action. This notice solicits 
comments on proposed information collection requirements relating to 
ACL funded training, case consultation, and technical assistance for 
aging/disability networks assisting older adults in social or economic 
need facing legal issues.

DATES: Submit written or electronic comments on the collection of 
information by February 5, 2018.

ADDRESSES: Submit electronic comments on the collection of information 
to Omar Valverde at omar.valverde@acl.hhs.gov. Submit written comments 
on the collection of information by mail to Omar Valverde, 
Administration for Community Living, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Omar Valverde at 
omar.valverde@acl.hhs.gov or (202) 795-7460.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension or update of an existing collection of 
information, before submitting the collection to OMB for approval. The 
proposed collection of information represents new information requested 
from aging/disability networks to fulfill requirements regarding the 
provision of services and overall performance of ACL legal assistance 
programs.
    To comply with the above requirement, ACL is publishing a notice 
regarding the proposed collection of information set forth in this 
document. ACL contracts with a national legal assistance resource 
center, the National Center on Law and Elder Rights, to provide the 
required services. Through the contract, ACL provides aging, 
disability, and related legal professionals with training and complex 
case consultations and support for demonstration projects regarding 
contractually identified priority legal topics.
    The purpose of the information requested is for ACL to ensure that 
the resource center creates and prioritizes the training, case 
consultations and technical assistance resources it was contracted to 
provide and to ensure that the center targets the contractually 
designated aging network practitioners about the priority subject 
matters. This approach enables ACL to make data-informed decisions 
about the deployment of its resource center assets. These data are 
necessary for ACL to evaluate contractual compliance with established 
performance indicators. These metrics include quantifiable increases in 
uptake by stakeholders of training, case consultation and technical 
assistance, and measures of satisfaction with and perceived benefit 
from these services. For example, the metrics measure successful 
problem resolution as a result of the services provided,

[[Page 57459]]

quantifiable data on fulfillment of requests for training, technical 
assistance, and consultation related to the contractually designated 
legal and systems development topic areas.
    Interested persons are invited to send comments regarding burden 
estimates or any other aspect of this collection of information, 
including the following subjects: (1) Whether the proposed collection 
of information is necessary for the proper performance of ACL's 
functions, including whether the information will have practical 
utility; (2) the accuracy of ACL's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Proposed Collection of Information

    ACL plans to submit the proposed data collection to the Office of 
Management and Budget for approval following receipt of any comments 
received in response to this notice. The information to be requested by 
ACL from legal and aging/disability professionals fall into the 
following areas: (1) Requests for training, case consultation, and 
technical assistance through an online, secure Uniform Resource Support 
Request Tool; (2) general requests for Legal Training (including the 
volume of Webinar registrations); Case Consultation and Technical 
Assistance; and (3) information about satisfaction and use of the 
services and support received in order to enable ACL to measure 
performance outcomes.

(1) Resource Support Requests

    ACL proposes to ask aging/disability service providers and legal 
service providers who may need various forms of resource support a 
series of questions regarding appropriate delivery of needed assistance 
in a targeted and efficient manner. These questions will be presented 
through a web based Uniform Resource Support Request Tool (URSRT) that 
will be used for soliciting and accepting requests for Legal Training, 
Case Consultation, and Technical Assistance (Link to URSRT).

Estimated Number of Responses

    ACL expects to receive (30) responses to questions presented in the 
URSRT from Legal Assistance Developers (LADs) (Title VII, Section 731) 
housed in SUAs and (50) responses from Older Americans Act (OAA) Title 
III-B legal providers in the first year. In subsequent years, the URSRT 
will be targeted for use by other groups within aging/disability and 
elder rights networks and may experience a large increase in responses.

Total Estimated Burden Hours

    The burden hours are calculated as (1) minute and 54 seconds to 
complete the URSRT per respondent, with a total of 2.53 hours, 
annually. Attachment A, which is posted along with the draft forms on 
the acl.gov Web site, explains the estimated response rate and burden 
calculations.

(2) Legal Training, Case Consultation, Technical Assistance Requests

    ACL proposes to ask legal and aging/disability providers who 
request Legal Training, Case Consultation, or Technical Assistance 
through the web-based Uniform Resource Support Request Tool (URSRT) for 
background information and the following substantive data:
     Type of Organization (Title III-B attorney, Legal Services 
Corporation attorney, Other Legal Services attorney, Other Elder Law 
attorney, Other Legal Services professional, Aging and/or Disability 
Network Professional, Other); and
     Services requested: (Legal Training, Case Consultation, 
Technical Assistance on Legal Services Delivery, or General 
Information).

Estimated Number of Responses

    Based on the results of prior data collections, ACL expects between 
13,000 and 14,000 requests annually through the web-based Uniform 
Resource Support Request Tool (URSRT). In subsequent years, enhanced 
public awareness of the availability of Legal Training, Case 
Consultation, and Technical Assistance within aging/disability/legal 
networks may increase potential responses to as high as 16,000.

Total Estimated Burden Hours

    The burden of hours is calculated at (1) minute 42 seconds for each 
respondent to make a request for Training, Case Consultation, or 
Technical Assistance. ACL estimates a high end of 14,000 responses with 
burden hours totaling 396 hours, annually. Attachment A, which is 
posted along with the draft forms on the acl.gov Web site, explains the 
estimated response rate and the burden calculation.

(3) Performance Outcome Measurement

    ACL proposes to ask legal and aging/disability providers, who 
request Legal Training, Case Consultation or Technical Assistance, the 
following series of survey questions in order to properly assess 
audience targeting, participant satisfaction, and outcomes of the 
training and technical assistance delivered:
     Type of Organization (Title III-B attorney, Legal Services 
Corporation attorney, Other Legal Services attorney, Other Elder Law 
attorney, Other Legal Services professional, Aging and/or Disability 
Network Professional, and Other Job Title (e.g., Executive Director, 
Management, Staff Attorney, Counselor);
     Please rank the quality of assistance provided in this 
(Legal Training/Case Consultation/Technical Assistance);
     Did the assistance provided by this (Legal Training/Case 
Consultation/Technical Assistance) contribute to a successful 
resolution of a specific client issue?
     If requesting assistance on legal services delivery, will 
the assistance provided contribute to the successful completion of 
legal needs and capacity assessments, legal services delivery plans, 
legal service delivery standards, or data collection/reporting systems?

Estimated Number of Responses

    ACL expects between 3,000 and 3,500 responses to follow up surveys 
presented through the web-based Uniform Resource Support Request Tool 
(URSRT) gaging participant satisfaction and service impacts derived 
from Training, Case Consultation, or Technical Assistance. In 
subsequent years, due to an increase in the volume of resource support 
provided, survey responses may increase to as high as 4,500 due to 
ongoing efforts to increase awareness of the availability of resource 
support through NCLER.

Total Estimated Burden Hours

    The burden of hours is calculated at (1) minute and 3 seconds for 
each respondent to complete a survey gaging satisfaction and service 
impact. ACL estimates a high end of 3,500 responses with a burden of 
hours totaling 61.25 hours, annually. Attachment A, which is posted 
along with the draft forms on the acl.gov Web site, explains the 
estimated response rate and the burden calculation.
    The proposed data collection forms and Attachment A may be found on 
the ACL Web site for review at: https://www.acl.gov/about-acl/public-input

[[Page 57460]]



                                           Summary of Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                             Number of
   Respondent/data collection activity      respondents      Minutes per response         Annual burden hours
----------------------------------------------------------------------------------------------------------------
Resource Support Requests...............              80  1 min 54 sec..............  2.53 hours.
Legal Training, Case Consultation,                14,000  1 min 42 sec..............  397 hours.
 Technical Assistance Requests.
Outcome Measurement.....................           3,500  1 min 3 sec...............  61.25 hours.
                                         -----------------------------------------------------------------------
    Total...............................          17,580  4 min 39 sec..............  460.78 hours.
----------------------------------------------------------------------------------------------------------------


    Dated: November 24, 2017.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2017-26116 Filed 12-4-17; 8:45 am]
 BILLING CODE 4154-01-P



                                                57458                       Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices

                                                laboratory quality and safety practices,                between diagnostic facilities and                     FOR FURTHER INFORMATION CONTACT:
                                                research, standards, and guidelines, and                healthcare providers, electronic                      Omar Valverde at omar.valverde@
                                                coordinates clinical and public health                  reporting of laboratory information to                acl.hhs.gov or (202) 795–7460.
                                                laboratory improvement efforts among                    electronic health records, and general                SUPPLEMENTARY INFORMATION: Under the
                                                all; (10) provides safety and quality                   preparedness of the laboratory system to              PRA (44 U.S.C. 3501–3520), Federal
                                                subject matter expertise to the Training                respond to public health emergencies;                 agencies must obtain approval from the
                                                and Workforce Development Branch for                    (6) develops and implements computer-                 Office of Management and Budget
                                                the development of training courses for                 based decision support tools and mobile               (OMB) for each collection of
                                                internal CDC laboratories and external                  applications that help to inform better               information they conduct or sponsor.
                                                clinical and public health laboratories;                laboratory-related decision-making by                 ‘‘Collection of information’’ is defined
                                                (11) provides advice and oversight of                   healthcare providers; and (7)                         in 44 U.S.C. 3502(3) and 5 CFR
                                                safety and quality measures, controls,                  collaborates with other CDC programs to               1320.3(c) and includes agency requests
                                                practices and documents to ensure                       develop and promote informatics                       or requirements that members of the
                                                compliance of DLS laboratory areas with                 solutions for improving laboratory                    public submit reports, keep records, or
                                                CDC policies, regulations, and                          management, practice, and                             provide information to a third party.
                                                guidelines for laboratory quality and                   preparedness.                                         Section 3506(c)(2)(A) of the PRA (44
                                                safety (e.g., Roybal campus—Building                    Sherri A. Berger,                                     U.S.C. 3506(c)(2)(A)) requires Federal
                                                18 Training Laboratory and                              Chief Operating Officer, Centers for Disease          agencies to provide a 60-day notice in
                                                Lawrenceville campus laboratories); (12)                Control and Prevention.                               the Federal Register concerning each
                                                provides scientific and technical                       [FR Doc. 2017–26148 Filed 12–4–17; 8:45 am]           proposed collection of information,
                                                support and guidance for CDC                                                                                  including each proposed extension or
                                                                                                        BILLING CODE 4160–18–P
                                                initiatives, programs, committees, work                                                                       update of an existing collection of
                                                groups, and task forces involving use,                                                                        information, before submitting the
                                                handling, shipping, import/export,                      DEPARTMENT OF HEALTH AND                              collection to OMB for approval. The
                                                transport or storage of biological                      HUMAN SERVICES                                        proposed collection of information
                                                specimens and their support materials;                                                                        represents new information requested
                                                (13) provides safety and quality-related                Administration for Community Living                   from aging/disability networks to fulfill
                                                content expertise for the development of                                                                      requirements regarding the provision of
                                                the Laboratory Leadership Service (LLS)                 Agency Information Collection                         services and overall performance of ACL
                                                Fellows curriculum and serve as course                  Activities; Proposed Collection; Public               legal assistance programs.
                                                instructors for LLS training classes (and               Comments Request; New Data                               To comply with the above
                                                to other laboratory-related workforce                   Collection; National Center on Law and                requirement, ACL is publishing a notice
                                                efforts as may be requested by other                    Elder Rights (NCLER)                                  regarding the proposed collection of
                                                programs); and (14) serves as quality                   AGENCY:  Administration for Community                 information set forth in this document.
                                                and safety advisors and liaisons to other               Living, HHS.                                          ACL contracts with a national legal
                                                CDC programs and offices involving                      ACTION: Notice.                                       assistance resource center, the National
                                                clinical laboratory activities upon                                                                           Center on Law and Elder Rights, to
                                                request.                                                SUMMARY:   The Administration for                     provide the required services. Through
                                                   Informatics and Data Science Branch                  Community Living (ACL) is announcing                  the contract, ACL provides aging,
                                                (CPNBE). (1) Supports the CDC                           an opportunity for the public to                      disability, and related legal
                                                Specimen Policy Board and OADLSS in                     comment on ACL’s intention to collect                 professionals with training and complex
                                                the development of CDC specimen                         information from legal and aging/                     case consultations and support for
                                                management and collection policies,                     disability service professionals. Under               demonstration projects regarding
                                                and oversees implementation of those                    the Paperwork Reduction Act of 1995                   contractually identified priority legal
                                                policies at CASPIR in collaboration with                (the PRA), Federal agencies are required              topics.
                                                the CASPIR Advisory Committee; (2)                      to publish a notice in the Federal                       The purpose of the information
                                                develops, promotes, implements, and                     Register concerning each proposed                     requested is for ACL to ensure that the
                                                evaluates data science approaches for                   collection of Information and to allow                resource center creates and prioritizes
                                                improved research of large and complex                  60 days for public comment in response                the training, case consultations and
                                                data sets in support of CLIA standards                  on the proposed action. This notice                   technical assistance resources it was
                                                and laboratory practice; (3) maintains                  solicits comments on proposed                         contracted to provide and to ensure that
                                                and leverages data acquired from                        information collection requirements                   the center targets the contractually
                                                national laboratory systems and other                   relating to ACL funded training, case                 designated aging network practitioners
                                                large health databases to evaluate                      consultation, and technical assistance                about the priority subject matters. This
                                                laboratory testing events, capabilities,                for aging/disability networks assisting               approach enables ACL to make data-
                                                capacity, and public health outcomes;                   older adults in social or economic need               informed decisions about the
                                                (4) develops solutions to strengthen the                facing legal issues.                                  deployment of its resource center assets.
                                                management of laboratory test service                   DATES: Submit written or electronic                   These data are necessary for ACL to
                                                capability and capacity data,                           comments on the collection of                         evaluate contractual compliance with
                                                biorepositories, access to materials for                information by February 5, 2018.                      established performance indicators.
                                                standardizing laboratory testing, as well               ADDRESSES: Submit electronic                          These metrics include quantifiable
sradovich on DSK3GMQ082PROD with NOTICES




                                                as support laboratory preparedness and                  comments on the collection of                         increases in uptake by stakeholders of
                                                workforce development activities; (5)                   information to Omar Valverde at                       training, case consultation and technical
                                                develops and implements solutions,                      omar.valverde@acl.hhs.gov. Submit                     assistance, and measures of satisfaction
                                                often with external partners and                        written comments on the collection of                 with and perceived benefit from these
                                                collaborators, to strengthen clinical and               information by mail to Omar Valverde,                 services. For example, the metrics
                                                public health laboratory information                    Administration for Community Living,                  measure successful problem resolution
                                                systems, reporting of laboratory results                Washington, DC 20201.                                 as a result of the services provided,


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                                                                            Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices                                           57459

                                                quantifiable data on fulfillment of                     (LADs) (Title VII, Section 731) housed                (3) Performance Outcome Measurement
                                                requests for training, technical                        in SUAs and (50) responses from Older                    ACL proposes to ask legal and aging/
                                                assistance, and consultation related to                 Americans Act (OAA) Title III–B legal                 disability providers, who request Legal
                                                the contractually designated legal and                  providers in the first year. In subsequent            Training, Case Consultation or
                                                systems development topic areas.                        years, the URSRT will be targeted for                 Technical Assistance, the following
                                                  Interested persons are invited to send                use by other groups within aging/                     series of survey questions in order to
                                                comments regarding burden estimates or                  disability and elder rights networks and              properly assess audience targeting,
                                                any other aspect of this collection of                  may experience a large increase in                    participant satisfaction, and outcomes of
                                                information, including the following                    responses.                                            the training and technical assistance
                                                subjects: (1) Whether the proposed
                                                                                                        Total Estimated Burden Hours                          delivered:
                                                collection of information is necessary
                                                                                                          The burden hours are calculated as (1)                 • Type of Organization (Title III–B
                                                for the proper performance of ACL’s
                                                                                                        minute and 54 seconds to complete the                 attorney, Legal Services Corporation
                                                functions, including whether the
                                                                                                        URSRT per respondent, with a total of                 attorney, Other Legal Services attorney,
                                                information will have practical utility;
                                                                                                        2.53 hours, annually. Attachment A,                   Other Elder Law attorney, Other Legal
                                                (2) the accuracy of ACL’s estimate of the
                                                                                                        which is posted along with the draft                  Services professional, Aging and/or
                                                burden of the proposed collection of
                                                                                                        forms on the acl.gov Web site, explains               Disability Network Professional, and
                                                information, including the validity of
                                                                                                        the estimated response rate and burden                Other Job Title (e.g., Executive Director,
                                                the methodology and assumptions used;
                                                                                                        calculations.                                         Management, Staff Attorney,
                                                (3) ways to enhance the quality, utility,
                                                                                                                                                              Counselor);
                                                and clarity of the information to be
                                                collected; and (4) ways to minimize the
                                                                                                        (2) Legal Training, Case Consultation,                   • Please rank the quality of assistance
                                                                                                        Technical Assistance Requests                         provided in this (Legal Training/Case
                                                burden of the collection of information
                                                on respondents, including through the                      ACL proposes to ask legal and aging/               Consultation/Technical Assistance);
                                                use of automated collection techniques,                 disability providers who request Legal                   • Did the assistance provided by this
                                                when appropriate, and other forms of                    Training, Case Consultation, or                       (Legal Training/Case Consultation/
                                                information technology.                                 Technical Assistance through the web-                 Technical Assistance) contribute to a
                                                                                                        based Uniform Resource Support                        successful resolution of a specific client
                                                Proposed Collection of Information                      Request Tool (URSRT) for background                   issue?
                                                   ACL plans to submit the proposed                     information and the following                            • If requesting assistance on legal
                                                data collection to the Office of                        substantive data:                                     services delivery, will the assistance
                                                Management and Budget for approval                         • Type of Organization (Title III–B                provided contribute to the successful
                                                following receipt of any comments                       attorney, Legal Services Corporation                  completion of legal needs and capacity
                                                received in response to this notice. The                attorney, Other Legal Services attorney,              assessments, legal services delivery
                                                information to be requested by ACL                      Other Elder Law attorney, Other Legal                 plans, legal service delivery standards,
                                                from legal and aging/disability                         Services professional, Aging and/or                   or data collection/reporting systems?
                                                professionals fall into the following                   Disability Network Professional, Other);              Estimated Number of Responses
                                                areas: (1) Requests for training, case                  and
                                                consultation, and technical assistance                     • Services requested: (Legal Training,               ACL expects between 3,000 and 3,500
                                                through an online, secure Uniform                       Case Consultation, Technical Assistance               responses to follow up surveys
                                                Resource Support Request Tool; (2)                      on Legal Services Delivery, or General                presented through the web-based
                                                general requests for Legal Training                     Information).                                         Uniform Resource Support Request Tool
                                                (including the volume of Webinar                                                                              (URSRT) gaging participant satisfaction
                                                                                                        Estimated Number of Responses                         and service impacts derived from
                                                registrations); Case Consultation and
                                                Technical Assistance; and (3)                             Based on the results of prior data                  Training, Case Consultation, or
                                                information about satisfaction and use                  collections, ACL expects between                      Technical Assistance. In subsequent
                                                of the services and support received in                 13,000 and 14,000 requests annually                   years, due to an increase in the volume
                                                order to enable ACL to measure                          through the web-based Uniform                         of resource support provided, survey
                                                performance outcomes.                                   Resource Support Request Tool                         responses may increase to as high as
                                                                                                        (URSRT). In subsequent years, enhanced                4,500 due to ongoing efforts to increase
                                                (1) Resource Support Requests                           public awareness of the availability of               awareness of the availability of resource
                                                   ACL proposes to ask aging/disability                 Legal Training, Case Consultation, and                support through NCLER.
                                                service providers and legal service                     Technical Assistance within aging/                    Total Estimated Burden Hours
                                                providers who may need various forms                    disability/legal networks may increase
                                                of resource support a series of questions               potential responses to as high as 16,000.                The burden of hours is calculated at
                                                regarding appropriate delivery of                                                                             (1) minute and 3 seconds for each
                                                                                                        Total Estimated Burden Hours                          respondent to complete a survey gaging
                                                needed assistance in a targeted and
                                                efficient manner. These questions will                    The burden of hours is calculated at                satisfaction and service impact. ACL
                                                be presented through a web based                        (1) minute 42 seconds for each                        estimates a high end of 3,500 responses
                                                Uniform Resource Support Request Tool                   respondent to make a request for                      with a burden of hours totaling 61.25
                                                (URSRT) that will be used for soliciting                Training, Case Consultation, or                       hours, annually. Attachment A, which
                                                and accepting requests for Legal                        Technical Assistance. ACL estimates a                 is posted along with the draft forms on
sradovich on DSK3GMQ082PROD with NOTICES




                                                Training, Case Consultation, and                        high end of 14,000 responses with                     the acl.gov Web site, explains the
                                                Technical Assistance (Link to URSRT).                   burden hours totaling 396 hours,                      estimated response rate and the burden
                                                                                                        annually. Attachment A, which is                      calculation.
                                                Estimated Number of Responses                           posted along with the draft forms on the                 The proposed data collection forms
                                                   ACL expects to receive (30) responses                acl.gov Web site, explains the estimated              and Attachment A may be found on the
                                                to questions presented in the URSRT                     response rate and the burden                          ACL Web site for review at: https://
                                                from Legal Assistance Developers                        calculation.                                          www.acl.gov/about-acl/public-input



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                                                57460                                Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices

                                                                                                                               SUMMARY OF BURDEN ESTIMATES
                                                                                                                                                  Number of                     Minutes per
                                                                   Respondent/data collection activity                                                                                                              Annual burden hours
                                                                                                                                                 respondents                     response

                                                Resource Support Requests .....................................................                             80      1 min 54 sec ...........................    2.53 hours.
                                                Legal Training, Case Consultation, Technical Assistance Re-                                             14,000      1 min 42 sec ...........................    397 hours.
                                                  quests.
                                                Outcome Measurement ............................................................                            3,500   1 min 3 sec .............................   61.25 hours.

                                                     Total ...................................................................................          17,580      4 min 39 sec ...........................    460.78 hours.



                                                  Dated: November 24, 2017.                                               FDA intends to follow for such                                     Instructions: All submissions received
                                                Mary Lazare,                                                              categorization decisions.                                       must include the Docket No. FDA–
                                                Principal Deputy Administrator.                                           DATES: The announcement of the                                  2016–D–1159 for ‘‘FDA Categorization
                                                [FR Doc. 2017–26116 Filed 12–4–17; 8:45 am]                               guidance is published in the Federal                            of Investigational Device Exemption
                                                BILLING CODE 4154–01–P                                                    Register on December 5, 2017.                                   (IDE) Devices to Assist the Centers for
                                                                                                                          ADDRESSES: You may submit either                                Medicare and Medicaid Services (CMS)
                                                                                                                          electronic or written comments on this                          with Coverage Decisions; Guidance for
                                                DEPARTMENT OF HEALTH AND                                                  guidance at any time as follows:                                Sponsors, Clinical Investigators,
                                                HUMAN SERVICES                                                                                                                            Industry, Institutional Review Boards,
                                                                                                                          Electronic Submissions                                          and Food and Drug Administration
                                                Food and Drug Administration                                                Submit electronic comments in the                             Staff.’’ Received comments will be
                                                                                                                          following way:                                                  placed in the docket and, except for
                                                [Docket No. FDA–2016–D–1159]
                                                                                                                            • Federal eRulemaking Portal:                                 those submitted as ‘‘Confidential
                                                Food and Drug Administration                                              https://www.regulations.gov. Follow the                         Submissions,’’ publicly viewable at
                                                Categorization of Investigational                                         instructions for submitting comments.                           https://www.regulations.gov or at the
                                                Device Exemption Devices To Assist                                        Comments submitted electronically,                              Dockets Management Staff office
                                                the Centers for Medicare and Medicaid                                     including attachments, to https://                              between 9 a.m. and 4 p.m., Monday
                                                Services With Coverage Decisions;                                         www.regulations.gov will be posted to                           through Friday.
                                                Guidance for Sponsors, Clinical                                           the docket unchanged. Because your                                 • Confidential Submissions—To
                                                Investigators, Industry, Institutional                                    comment will be made public, you are                            submit a comment with confidential
                                                Review Boards, and Food and Drug                                          solely responsible for ensuring that your                       information that you do not wish to be
                                                Administration Staff; Availability                                        comment does not include any                                    made publicly available, submit your
                                                                                                                          confidential information that you or a                          comments only as a written/paper
                                                AGENCY:      Food and Drug Administration,                                third party may not wish to be posted,                          submission. You should submit two
                                                HHS.                                                                      such as medical information, your or                            copies total. One copy will include the
                                                ACTION:     Notice of availability.                                       anyone else’s Social Security number, or                        information you claim to be confidential
                                                                                                                          confidential business information, such                         with a heading or cover note that states
                                                SUMMARY:    The Food and Drug                                             as a manufacturing process. Please note                         ‘‘THIS DOCUMENT CONTAINS
                                                Administration (FDA or Agency) is                                         that if you include your name, contact                          CONFIDENTIAL INFORMATION.’’ The
                                                announcing the availability of the                                        information, or other information that                          Agency will review this copy, including
                                                guidance entitled ‘‘FDA Categorization                                    identifies you in the body of your                              the claimed confidential information, in
                                                of Investigational Device Exemption                                       comments, that information will be                              its consideration of comments. The
                                                (IDE) Devices to Assist the Centers for                                   posted on https://www.regulations.gov.                          second copy, which will have the
                                                Medicare and Medicaid Services (CMS)                                        • If you want to submit a comment                             claimed confidential information
                                                with Coverage Decisions; Guidance for                                     with confidential information that you                          redacted/blacked out, will be available
                                                Sponsors, Clinical Investigators,                                         do not wish to be made available to the                         for public viewing and posted on
                                                Industry, Institutional Review Boards,                                    public, submit the comment as a                                 https://www.regulations.gov. Submit
                                                and Food and Drug Administration                                          written/paper submission and in the                             both copies to the Dockets Management
                                                Staff.’’ This guidance modifies the                                       manner detailed (see ‘‘Written/Paper                            Staff. If you do not wish your name and
                                                FDA’s current policy on categorization                                    Submissions’’ and ‘‘Instructions’’).                            contact information to be made publicly
                                                of investigational device exemption                                                                                                       available, you can provide this
                                                (IDE) devices, which assists the CMS in                                   Written/Paper Submissions                                       information on the cover sheet and not
                                                determining whether or not an IDE                                           Submit written/paper submissions as                           in the body of your comments and you
                                                device should be covered (reimbursed)                                     follows:                                                        must identify this information as
                                                by CMS. On December 2, 2015, FDA’s                                          • Mail/Hand delivery/Courier (for                             ‘‘confidential.’’ Any information marked
                                                Center for Devices and Radiological                                       written/paper submissions): Dockets                             as ‘‘confidential’’ will not be disclosed
                                                Health (CDRH) and CMS’s Coverage and                                      Management Staff (HFA–305), Food and                            except in accordance with 21 CFR 10.20
                                                Analysis Group (CAG) executed a                                           Drug Administration, 5630 Fishers                               and other applicable disclosure law. For
                                                Memorandum of Understanding (MOU)                                         Lane, Rm. 1061, Rockville, MD 20852.                            more information about FDA’s posting
sradovich on DSK3GMQ082PROD with NOTICES




                                                to streamline and facilitate the efficient                                  • For written/paper comments                                  of comments to public dockets, see 80
                                                categorization of investigational medical                                 submitted to the Dockets Management                             FR 56469, September 18, 2015, or access
                                                devices in order to support CMS’s                                         Staff, FDA will post your comment, as                           the information at: https://www.gpo.gov/
                                                ability to make Medicare coverage                                         well as any attachments, except for                             fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                (reimbursement) determinations for                                        information submitted, marked and                               23389.pdf.
                                                those devices. This guidance document                                     identified, as confidential, if submitted                          Docket: For access to the docket to
                                                further explains the framework that                                       as detailed in ‘‘Instructions.’’                                read background documents or the


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Document Created: 2017-12-04 23:45:32
Document Modified: 2017-12-04 23:45:32
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.
DatesSubmit written or electronic comments on the collection of information by February 5, 2018.
ContactOmar Valverde at [email protected] or (202) 795-7460.
FR Citation82 FR 57458 

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