Agency Information Collection Activities; Proposed Collection; Public Comment Request; Revision of a Currently Approved Information Collection (OMB Approval Number 0985-0048); State Grants for Assistive Technology Program State Plan for Assistive Technology, 57278-57279 [2017-26018]

Download as PDF 57278 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices Estimated Total Annual Burden Hours: 125. Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–26061 Filed 12–1–17; 8:45 am] BILLING CODE 4184–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Proposed Collection; Public Comment Request; Revision of a Currently Approved Information Collection (OMB Approval Number 0985–0048); State Grants for Assistive Technology Program State Plan for Assistive Technology Administration for Community Living, Department of Health and Human Services. ACTION: Notice. AGENCY: The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995 (the PRA). This 30-day notice requests comments on the information collection requirements related to a proposed Revision of a Currently Approved Information Collection (ICR-Rev). The revision will allow ACL to continue to sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:22 Dec 01, 2017 Jkt 244001 collect information necessary to determine grantee compliance with Section 4 of the Assistive Technology Act of 1998, as Amended (AT Act). DATES: Submit written or electronic comments on the collection of information by January 3, 2018. ADDRESSES: Submit written comments on the collection of information: by fax at (202) 395–5806 or by email to OIRA_ submission@omb.eop.gov, Attn: OMB Desk Officer for ACL. FOR FURTHER INFORMATION CONTACT: Robert Groenendaal at (202) 795–7356 or Robert.Groenendaal@acl.hhs.gov. 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 data collection represents a revision of a currently approved collection (ICR-Rev). In order to comply with the above requirement, ACL is requesting approval of a revision of a previously approved collection, the State Grants for Assistive Technology Program State Plan for AT, formerly known as the 664 report (0985–0048). The State Plan for AT is submitted every three years and updated annually by all State Grants for AT programs receiving formula funds under Section 4 of the Assistive Technology Act of 1998, as Amended (AT Act). The State Plan for AT is used by ACL to assess grantees’ compliance with Section 4 of the AT Act and enables ACL to analyze qualitative and quantitative information to track performance outcomes and efficiency measures of the State Grants for AT programs; support budget requests; comply with the GPRA Modernization Act of 2010 (GPRAMA) reporting requirements; provide national benchmark information; and inform program development and management activities. The burden table below identifies the data collection activities for the instrument as well as the estimates for record keeping and entry of aggregate data. In addition to PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 submitting a State Plan every three years, states and outlying areas are required to submit annual progress reports on their activities. The data required for these progress reports is specified in Section 4(f) of the AT Act. The State Grants for AT program conduct the following state-level and state leadership activities: device demonstration, device loans, device reutilization, state financing, training and technical assistance, public awareness, and information and referral. Comments in Response to the 60-Day Federal Register Notice A 60-day notice was published in the Federal Register in Vol. 82, No. 178, pg. 43379 on September 15th, 2017. ACL received one comment from the Association of Assistive Technology Act Programs (ATAP), which represents 54 State Grant for AT programs. The comment noted that the proposed changes to the currently approved information collection were developed with extensive input of those it directly impacts, the State AT Program grantees. The revision process began almost two years ago and grantees had multiple opportunities to discuss and make recommendations on the proposed changes, which were reviewed during numerous meetings with ATAP membership at national conferences and during online events. There is uniform support within the ATAP membership for the revisions. Burden Estimates The proposed State Plan for Assistive Technology Information Collection Program may be found on the ACL Web site at: https://www.acl.gov/about-acl/ public-input. The total estimated hour burden per respondent for the proposed State Plan for AT will decrease from the 74 hours per respondent estimated in FY 2015 to 73 hours estimated for FY 2018, an estimated reduction of one hour per respondent or 56 hours in total. The proposed State Plan for AT changes focus on a streamline of drop down choice lists in the current instrument. Actual expenditure data elements for state-level and state leadership tracking replaces the budget projections to provide more accurate fiscal data to ACL and to ensure compliance with AT Act requirements for expenditures. The proposed instrument simplifies the coordination and collaboration items to focus on activities conducted through a formal written agreement to ensure consistency and usefulness of data reported. The revised instrument aligns demographic data elements with the AT Annual Performance Report (APR), so E:\FR\FM\04DEN1.SGM 04DEN1 57279 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices that the data will be: Entered once, then only updated from that point on; used for both the State Plan and APR; updated quarterly with reminders; and used to populate the online State AT Program listing to ensure currency and accuracy. The reduction in burden is a result of a data collection workgroup composed of State AT program staff that met to suggest revisions to the current instrument. The workgroup solicited feedback from all of the grantees through face-to-face meetings and webinar presentations. The number of hours is multiplied by 56 AT State Grants programs, resulting in a total estimated hour burden of 4,088 hours. Respondent/data collection activity Number of respondents Responses per respondent Hours per response Annual burden hours State Plan for AT Annual Progress Report (AT APR) .................................. 56 1 73.0 4,088 Dated: November 24, 2017. Mary Lazare, Principal Deputy Administrator. [FR Doc. 2017–26018 Filed 12–1–17; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–4853] Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant’s biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register. FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993–0002, 240–402–0979, daniel.orr@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111– 148) on March 23, 2010. The BPCI Act amended the PHS Act and created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. Section 351(k) of the PHS Act sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:22 Dec 01, 2017 Jkt 244001 (42 U.S.C. 262(k)), added by the BPCI Act, describes the requirements for a BLA for a proposed biosimilar product or a proposed interchangeable product (351(k) BLA). Section 351(l) of the PHS Act, also added by the BPCI Act, describes certain procedures for exchanging patent information and resolving patent disputes between a 351(k) BLA applicant and the holder of the BLA reference product. If a 351(k) applicant is served with a complaint for a patent infringement described in section 351(l)(6) of the PHS Act, the applicant is required to provide FDA with notice and a copy of the complaint within 30 days of service. FDA is required to publish notice of a complaint received under section 351(l)(6)(C) of the PHS Act in the Federal Register. FDA received notice of the following complaint under section 351(l)(6)(C) of the PHS Act: AbbVie, Inc., et al. v. Boehringer Ingelheim Intl. GMBH., et al., 17–cv– 01065 (D. Del., filed August 2, 2017). This complaint involves the product Humira. FDA has only a ministerial role in publishing notice of a complaint received under section 351(l)(6)(C) of the PHS Act, and does not perform a substantive review of the complaint. Dated: November 28, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26013 Filed 12–1–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6475] Food and Drug Administration Fiscal Year 2017 Performance Review Board Members AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Fmt 4703 DATES: Effective October 30, 2017. Abu Sesay, Office of Human Resources Executive and Resources Management Staff, Food and Drug Administration, Three White Flint North, 05C68, 11601 Landsdown St., North Bethesda, MD 20852, 240–402–0440 (not a toll free number). FOR FURTHER INFORMATION CONTACT: This action is being taken pursuant to 5 U.S.C. 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register. The following persons will serve on the FDA Performance Review Board, which oversees the evaluation of performance appraisals of FDA’s senior executives: James Sigg, PRB Chair Tania Tse, PRB Officiator Glenda Barfell Janelle Barth Vincent Bunning Mary Beth Clarke Tracey Forfa Leslie Kux Diane Maloney Edward Margerrison Lynne Rice William Tootle SUPPLEMENTARY INFORMATION: Dated: November 28, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26015 Filed 12–1–17; 8:45 am] Notice. Frm 00085 The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42(f) SES Equivalents performance appraisals, bonus recommendations, and pay adjustments. SUMMARY: BILLING CODE 4164–01–P Sfmt 9990 E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57278-57279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26018]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request; Revision of a Currently Approved Information 
Collection (OMB Approval Number 0985-0048); State Grants for Assistive 
Technology Program State Plan for Assistive Technology

AGENCY: Administration for Community Living, Department of Health and 
Human Services.

ACTION: Notice.

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

SUMMARY: The Administration for Community Living (ACL) is announcing 
that the proposed collection of information listed above has been 
submitted to the Office of Management and Budget (OMB) for review and 
clearance as required under the Paperwork Reduction Act of 1995 (the 
PRA). This 30-day notice requests comments on the information 
collection requirements related to a proposed Revision of a Currently 
Approved Information Collection (ICR-Rev). The revision will allow ACL 
to continue to collect information necessary to determine grantee 
compliance with Section 4 of the Assistive Technology Act of 1998, as 
Amended (AT Act).

DATES: Submit written or electronic comments on the collection of 
information by January 3, 2018.

ADDRESSES: Submit written comments on the collection of information: by 
fax at (202) 395-5806 or by email to OIRA_submission@omb.eop.gov, Attn: 
OMB Desk Officer for ACL.

FOR FURTHER INFORMATION CONTACT: Robert Groenendaal at (202) 795-7356 
or Robert.Groenendaal@acl.hhs.gov.

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 data collection represents a revision of a currently approved 
collection (ICR-Rev). In order to comply with the above requirement, 
ACL is requesting approval of a revision of a previously approved 
collection, the State Grants for Assistive Technology Program State 
Plan for AT, formerly known as the 664 report (0985-0048).
    The State Plan for AT is submitted every three years and updated 
annually by all State Grants for AT programs receiving formula funds 
under Section 4 of the Assistive Technology Act of 1998, as Amended (AT 
Act). The State Plan for AT is used by ACL to assess grantees' 
compliance with Section 4 of the AT Act and enables ACL to analyze 
qualitative and quantitative information to track performance outcomes 
and efficiency measures of the State Grants for AT programs; support 
budget requests; comply with the GPRA Modernization Act of 2010 
(GPRAMA) reporting requirements; provide national benchmark 
information; and inform program development and management activities. 
The burden table below identifies the data collection activities for 
the instrument as well as the estimates for record keeping and entry of 
aggregate data. In addition to submitting a State Plan every three 
years, states and outlying areas are required to submit annual progress 
reports on their activities. The data required for these progress 
reports is specified in Section 4(f) of the AT Act. The State Grants 
for AT program conduct the following state-level and state leadership 
activities: device demonstration, device loans, device reutilization, 
state financing, training and technical assistance, public awareness, 
and information and referral.

Comments in Response to the 60-Day Federal Register Notice

    A 60-day notice was published in the Federal Register in Vol. 82, 
No. 178, pg. 43379 on September 15th, 2017. ACL received one comment 
from the Association of Assistive Technology Act Programs (ATAP), which 
represents 54 State Grant for AT programs. The comment noted that the 
proposed changes to the currently approved information collection were 
developed with extensive input of those it directly impacts, the State 
AT Program grantees. The revision process began almost two years ago 
and grantees had multiple opportunities to discuss and make 
recommendations on the proposed changes, which were reviewed during 
numerous meetings with ATAP membership at national conferences and 
during online events. There is uniform support within the ATAP 
membership for the revisions.

Burden Estimates

    The proposed State Plan for Assistive Technology Information 
Collection Program may be found on the ACL Web site at: https://www.acl.gov/about-acl/public-input.
    The total estimated hour burden per respondent for the proposed 
State Plan for AT will decrease from the 74 hours per respondent 
estimated in FY 2015 to 73 hours estimated for FY 2018, an estimated 
reduction of one hour per respondent or 56 hours in total. The proposed 
State Plan for AT changes focus on a streamline of drop down choice 
lists in the current instrument. Actual expenditure data elements for 
state-level and state leadership tracking replaces the budget 
projections to provide more accurate fiscal data to ACL and to ensure 
compliance with AT Act requirements for expenditures. The proposed 
instrument simplifies the coordination and collaboration items to focus 
on activities conducted through a formal written agreement to ensure 
consistency and usefulness of data reported. The revised instrument 
aligns demographic data elements with the AT Annual Performance Report 
(APR), so

[[Page 57279]]

that the data will be: Entered once, then only updated from that point 
on; used for both the State Plan and APR; updated quarterly with 
reminders; and used to populate the online State AT Program listing to 
ensure currency and accuracy. The reduction in burden is a result of a 
data collection workgroup composed of State AT program staff that met 
to suggest revisions to the current instrument. The workgroup solicited 
feedback from all of the grantees through face-to-face meetings and 
webinar presentations. The number of hours is multiplied by 56 AT State 
Grants programs, resulting in a total estimated hour burden of 4,088 
hours.

----------------------------------------------------------------------------------------------------------------
                                                Number of       Responses per      Hours per      Annual burden
    Respondent/data collection activity        respondents       respondent         response          hours
----------------------------------------------------------------------------------------------------------------
State Plan for AT Annual Progress Report                 56                 1             73.0            4,088
 (AT APR)..................................
----------------------------------------------------------------------------------------------------------------


    Dated: November 24, 2017.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2017-26018 Filed 12-1-17; 8:45 am]
BILLING CODE 4154-01-P