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)
Administration for Community Living
Federal Register Volume 82, Issue 232 (December 5, 2017)
| Page Range | 57458-57460 | |
| FR Document | 2017-26116 |
[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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![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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit written or electronic comments on the collection of information by February 5, 2018. | |
| Contact | Omar Valverde at [email protected] or (202) 795-7460. | |
| FR Citation | 82 FR 57458 |
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