82 FR 57278 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living Federal Register Volume 82, Issue 231 (December 4, 2017)
Administration for Community Living
Federal Register Volume 82, Issue 231 (December 4, 2017)
| Page Range | 57278-57279 | |
| FR Document | 2017-26018 |
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)] [Notices] [Pages 57278-57279] From the Federal Register Online [www.thefederalregister.org] [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 [email protected], Attn: OMB Desk Officer for ACL. FOR FURTHER INFORMATION CONTACT: Robert Groenendaal at (202) 795-7356 or [email protected]. 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
![57278 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
Estimated Total Annual Burden collect information necessary to submitting a State Plan every three
Hours: 125. determine grantee compliance with years, states and outlying areas are
Copies of the proposed collection may Section 4 of the Assistive Technology required to submit annual progress
be obtained by writing to the Act of 1998, as Amended (AT Act). reports on their activities. The data
Administration for Children and DATES: Submit written or electronic required for these progress reports is
Families, Office of Planning, Research comments on the collection of specified in Section 4(f) of the AT Act.
and Evaluation, 330 C Street SW., information by January 3, 2018. The State Grants for AT program
Washington, DC 20201. Attention ADDRESSES: Submit written comments conduct the following state-level and
Reports Clearance Officer. All requests on the collection of information: by fax state leadership activities: device
should be identified by the title of the at (202) 395–5806 or by email to OIRA_ demonstration, device loans, device
information collection. Email address: submission@omb.eop.gov, Attn: OMB reutilization, state financing, training
infocollection@acf.hhs.gov. Desk Officer for ACL. and technical assistance, public
FOR FURTHER INFORMATION CONTACT:
awareness, and information and referral.
OMB Comment
Robert Groenendaal at (202) 795–7356 Comments in Response to the 60-Day
OMB is required to make a decision
or Robert.Groenendaal@acl.hhs.gov. Federal Register Notice
concerning the collection of information
between 30 and 60 days after SUPPLEMENTARY INFORMATION: Under the A 60-day notice was published in the
publication of this document in the PRA (44 U.S.C. 3501–3520), Federal Federal Register in Vol. 82, No. 178, pg.
Federal Register. Therefore, a comment agencies must obtain approval from the 43379 on September 15th, 2017. ACL
is best assured of having its full effect Office of Management and Budget received one comment from the
if OMB receives it within 30 days of (OMB) for each collection of Association of Assistive Technology Act
publication. Written comments and information they conduct or sponsor. Programs (ATAP), which represents 54
recommendations for the proposed ‘‘Collection of information’’ is defined State Grant for AT programs. The
information collection should be sent in 44 U.S.C. 3502(3) and 5 CFR comment noted that the proposed
directly to the following: Office of 1320.3(c) and includes agency requests changes to the currently approved
Management and Budget, Paperwork or requirements that members of the information collection were developed
Reduction Project, email: OIRA_ public submit reports, keep records, or with extensive input of those it directly
SUBMISSION@OMB.EOP.GOV, Attn: provide information to a third party. impacts, the State AT Program grantees.
Desk Officer for the Administration for Section 3506(c)(2)(A) of the PRA (44 The revision process began almost two
Children and Families. U.S.C. 3506(c)(2)(A)) requires Federal years ago and grantees had multiple
agencies to provide a 60-day notice in opportunities to discuss and make
Robert Sargis, the Federal Register concerning each recommendations on the proposed
Reports Clearance Officer. proposed collection of information, changes, which were reviewed during
[FR Doc. 2017–26061 Filed 12–1–17; 8:45 am] including each proposed extension or numerous meetings with ATAP
BILLING CODE 4184–29–P update of an existing collection of membership at national conferences and
information, before submitting the during online events. There is uniform
collection to OMB for approval. The support within the ATAP membership
DEPARTMENT OF HEALTH AND proposed data collection represents a for the revisions.
HUMAN SERVICES revision of a currently approved
collection (ICR-Rev). In order to comply Burden Estimates
Administration for Community Living with the above requirement, ACL is The proposed State Plan for Assistive
requesting approval of a revision of a Technology Information Collection
Agency Information Collection previously approved collection, the Program may be found on the ACL Web
Activities; Proposed Collection; Public State Grants for Assistive Technology site at: https://www.acl.gov/about-acl/
Comment Request; Revision of a Program State Plan for AT, formerly public-input.
Currently Approved Information known as the 664 report (0985–0048). The total estimated hour burden per
Collection (OMB Approval Number The State Plan for AT is submitted respondent for the proposed State Plan
0985–0048); State Grants for Assistive every three years and updated annually for AT will decrease from the 74 hours
Technology Program State Plan for by all State Grants for AT programs per respondent estimated in FY 2015 to
Assistive Technology receiving formula funds under Section 4 73 hours estimated for FY 2018, an
AGENCY: Administration for Community of the Assistive Technology Act of 1998, estimated reduction of one hour per
Living, Department of Health and as Amended (AT Act). The State Plan respondent or 56 hours in total. The
Human Services. for AT is used by ACL to assess proposed State Plan for AT changes
ACTION: Notice. grantees’ compliance with Section 4 of focus on a streamline of drop down
the AT Act and enables ACL to analyze choice lists in the current instrument.
SUMMARY: The Administration for qualitative and quantitative information Actual expenditure data elements for
Community Living (ACL) is announcing to track performance outcomes and state-level and state leadership tracking
that the proposed collection of efficiency measures of the State Grants replaces the budget projections to
information listed above has been for AT programs; support budget provide more accurate fiscal data to
submitted to the Office of Management requests; comply with the GPRA ACL and to ensure compliance with AT
and Budget (OMB) for review and Modernization Act of 2010 (GPRAMA) Act requirements for expenditures. The
clearance as required under the reporting requirements; provide proposed instrument simplifies the
sradovich on DSK3GMQ082PROD with NOTICES
Paperwork Reduction Act of 1995 (the national benchmark information; and coordination and collaboration items to
PRA). This 30-day notice requests inform program development and focus on activities conducted through a
comments on the information collection management activities. The burden table formal written agreement to ensure
requirements related to a proposed below identifies the data collection consistency and usefulness of data
Revision of a Currently Approved activities for the instrument as well as reported. The revised instrument aligns
Information Collection (ICR-Rev). The the estimates for record keeping and demographic data elements with the AT
revision will allow ACL to continue to entry of aggregate data. In addition to Annual Performance Report (APR), so
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![Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices 57279
that the data will be: Entered once, then accuracy. The reduction in burden is a through face-to-face meetings and
only updated from that point on; used result of a data collection workgroup webinar presentations. The number of
for both the State Plan and APR; composed of State AT program staff that hours is multiplied by 56 AT State
updated quarterly with reminders; and met to suggest revisions to the current Grants programs, resulting in a total
used to populate the online State AT instrument. The workgroup solicited estimated hour burden of 4,088 hours.
Program listing to ensure currency and feedback from all of the grantees
Number of Responses per Hours per Annual
Respondent/data collection activity respondents respondent response burden hours
State Plan for AT Annual Progress Report (AT APR) .................................. 56 1 73.0 4,088
Dated: November 24, 2017. (42 U.S.C. 262(k)), added by the BPCI SUMMARY: The Food and Drug
Mary Lazare, Act, describes the requirements for a Administration (FDA) is announcing the
Principal Deputy Administrator. BLA for a proposed biosimilar product names of the members who will serve
[FR Doc. 2017–26018 Filed 12–1–17; 8:45 am] or a proposed interchangeable product on its Performance Review Board (PRB).
BILLING CODE 4154–01–P (351(k) BLA). Section 351(l) of the PHS The purpose of the PRB is to provide
Act, also added by the BPCI Act, fair and impartial review of senior
describes certain procedures for executive service (SES), senior
DEPARTMENT OF HEALTH AND exchanging patent information and professional and Title 42(f) SES
HUMAN SERVICES resolving patent disputes between a Equivalents performance appraisals,
351(k) BLA applicant and the holder of bonus recommendations, and pay
Food and Drug Administration the BLA reference product. If a 351(k) adjustments.
[Docket No. FDA–2017–N–4853] applicant is served with a complaint for
DATES: Effective October 30, 2017.
a patent infringement described in
Receipt of Notice That a Patent section 351(l)(6) of the PHS Act, the FOR FURTHER INFORMATION CONTACT: Abu
Infringement Complaint Was Filed applicant is required to provide FDA Sesay, Office of Human Resources
Against a Biosimilar Applicant with notice and a copy of the complaint Executive and Resources Management
within 30 days of service. FDA is Staff, Food and Drug Administration,
AGENCY: Food and Drug Administration, Three White Flint North, 05C68, 11601
required to publish notice of a
HHS. Landsdown St., North Bethesda, MD
complaint received under section
ACTION: Notice. 351(l)(6)(C) of the PHS Act in the 20852, 240–402–0440 (not a toll free
Federal Register. number).
SUMMARY: The Food and Drug
Administration (FDA) is publishing FDA received notice of the following SUPPLEMENTARY INFORMATION: This
notice that an applicant for a proposed complaint under section 351(l)(6)(C) of action is being taken pursuant to 5
biosimilar product notified FDA that a the PHS Act: U.S.C. 4314(c)(4), which requires that
patent infringement action was filed in AbbVie, Inc., et al. v. Boehringer members of performance review boards
connection with the applicant’s Ingelheim Intl. GMBH., et al., 17–cv– be appointed in a manner to ensure
biologics license application (BLA). 01065 (D. Del., filed August 2, 2017). consistency, stability, and objectivity in
Under the Public Health Service Act This complaint involves the product performance appraisals and requires
(PHS Act), an applicant for a proposed Humira. that notice of the appointment of an
biosimilar product or interchangeable FDA has only a ministerial role in individual to serve as a member be
product must notify FDA within 30 days publishing notice of a complaint published in the Federal Register.
after the applicant was served with a received under section 351(l)(6)(C) of The following persons will serve on
complaint in a patent infringement the PHS Act, and does not perform a the FDA Performance Review Board,
action described under the PHS Act. substantive review of the complaint. which oversees the evaluation of
FDA is required to publish notice of the Dated: November 28, 2017. performance appraisals of FDA’s senior
complaint in the Federal Register. Leslie Kux, executives:
FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. James Sigg, PRB Chair
Daniel Orr, Center for Drug Evaluation [FR Doc. 2017–26013 Filed 12–1–17; 8:45 am] Tania Tse, PRB Officiator
and Research, Food and Drug BILLING CODE 4164–01–P Glenda Barfell
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6246, Silver Spring, Janelle Barth
MD 20993–0002, 240–402–0979, DEPARTMENT OF HEALTH AND Vincent Bunning
daniel.orr@fda.hhs.gov. HUMAN SERVICES Mary Beth Clarke
SUPPLEMENTARY INFORMATION: The Tracey Forfa
Biologics Price Competition and Food and Drug Administration Leslie Kux
Innovation Act of 2009 (BPCI Act) was Diane Maloney
enacted as part of the Patient Protection [Docket No. FDA–2017–N–6475] Edward Margerrison
and Affordable Care Act (Pub. L. 111–
sradovich on DSK3GMQ082PROD with NOTICES
Lynne Rice
148) on March 23, 2010. The BPCI Act Food and Drug Administration Fiscal
Year 2017 Performance Review Board William Tootle
amended the PHS Act and created an
abbreviated licensure pathway for Members Dated: November 28, 2017.
biological products shown to be Leslie Kux,
AGENCY: Food and Drug Administration,
biosimilar to, or interchangeable with, Associate Commissioner for Policy.
HHS.
an FDA-licensed biological reference [FR Doc. 2017–26015 Filed 12–1–17; 8:45 am]
ACTION: Notice.
product. Section 351(k) of the PHS Act BILLING CODE 4164–01–P
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Document Created: 2017-12-02 00:40:56
Document Modified: 2017-12-02 00:40:56
| 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 January 3, 2018. | |
| Contact | Robert Groenendaal at (202) 795-7356 or [email protected] | |
| FR Citation | 82 FR 57278 |
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