Proposed Information Collection Activity; Comment Request, 18857-18858 [2016-07359]

Download as PDF 18857 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices policy questions regarding this collection contact Sarah Boehm at 301– 492–4429.) Dated: March 29, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: ORR–3 Placement Report and ORR–4 Progress Report for Unaccompanied Refugee Minors (URM) Program. OMB No.: 0970–0034. Description: As required by section 412(d) of the Immigration and Nationality Act, the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), is requesting the information from report Form ORR–3 and ORR–4 to administer the Unaccompanied Refugee Minors [FR Doc. 2016–07423 Filed 3–31–16; 8:45 am] BILLING CODE 4120–01–P (URM) program. The ORR–3 (Placement Report) is submitted to ORR by the State agency at the minor’s initial placement in the resettlement State within 30 days of the placement, and whenever there is a change in the minor’s status, including termination from the program, within 60 days of the change or closure of the case. The ORR–4 (Progress Report) is submitted every 12 months beginning with 12 months from the date of the initial placement to record outcomes of the child’s progress toward the goals listed in the child’s case plan. ORR–4 is also submitted along with the initial ORR–3 report for 17 years old or above youth related to independent living and/or educational plans. The ORR regulations per 45 CFR 400.120 describe specific URM program reporting requirements. Respondents: State governments. ANNUAL BURDEN ESTIMATES Instrument Number of respondents asabaliauskas on DSK3SPTVN1PROD with NOTICES ORR–3 ................................... ORR–4 ................................... 15 15 Estimated Total Annual Burden Hours: 3,048.75. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on VerDate Sep<11>2014 17:25 Mar 31, 2016 Jkt 238001 Number of responses per respondent Average burden hours per response Estimated responses 178 ...... Estimated responses 127 ...... 0.25 (15 min) ......................... 1.25 (1 hour and 15 min) ....... respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016–07361 Filed 3–31–16; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Low Income Home Energy Assistance Program (LIHEAP) Leveraging Report. OMB No.: 0970–0121. Description: The LIHEAP leveraging incentive program rewards LIHEAP grantees that have leveraged non-federal home energy resources for low-income households. The LIHEAP leveraging report is the application for leveraging incentive funds that the LIHEAP PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Total burden hours Estimated 667.5. Estimated 2,381.25. grantees submit to the U.S. Department of Health and Human Services (HHS) for each fiscal year in which they leverage countable resources. Participation in the leveraging incentive program is voluntary and is described at 45 CFR 96.87. The LIHEAP leveraging report obtains information on the resources leveraged by LIHEAP grantees each federal fiscal year, e.g., as cash, discounts, waivers, and in-kind; the benefits provided to low-income households by these resources, for example, as fuel and payments for fuel, as home heating and cooling equipment, and as weatherization materials and installation; and the fair market value of these resources/benefits. HHS needs this information in order to carry out federal statutory requirements for administering the LIHEAP leveraging incentive program, to determine accountability and valuation of grantees’ leveraged nonfederal home energy resources, and to determine grantees’ shares of leveraging incentive funds. HHS proposes to request a three-year clearance by OMB for the LIHEAP leveraging report information collection which has received OMB approval in the past. Respondents: State, Local or Tribal Governments. E:\FR\FM\01APN1.SGM 01APN1 18858 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours LIHEAP Leveraging Report ............................................................................. 70 1 38 2,660 Estimated Total Annual Burden Hours: 2,660. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016–07359 Filed 3–31–16; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES asabaliauskas on DSK3SPTVN1PROD with NOTICES Food and Drug Administration [Docket No. FDA–2015–N–2489] Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:25 Mar 31, 2016 Jkt 238001 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. SUMMARY: FDA has received notice of the following complaint under section 351(l)(6)(C) of the PHS Act: Amgen, Inc., v. Apotex, Inc., 15–cv– 61631 (consolidated with 15–cv–62081, S.D. Fla., filed October 2, 2015). 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: March 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–07364 Filed 3–31–16; 8:45 am] BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993–0002, 240–402–0979, daniel.orr@fda.hhs.gov. 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 (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, under section 351(l)(6)(C) of the PHS Act, to provide the 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0031] Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications. SUMMARY: Submit either electronic or written comments on the collection of information by May 31, 2016. DATES: ADDRESSES: You may submit comments as follows: E:\FR\FM\01APN1.SGM 01APN1

Agencies

[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18857-18858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: Low Income Home Energy Assistance Program (LIHEAP) 
Leveraging Report.
    OMB No.: 0970-0121.
    Description: The LIHEAP leveraging incentive program rewards LIHEAP 
grantees that have leveraged non-federal home energy resources for low-
income households. The LIHEAP leveraging report is the application for 
leveraging incentive funds that the LIHEAP grantees submit to the U.S. 
Department of Health and Human Services (HHS) for each fiscal year in 
which they leverage countable resources. Participation in the 
leveraging incentive program is voluntary and is described at 45 CFR 
96.87. The LIHEAP leveraging report obtains information on the 
resources leveraged by LIHEAP grantees each federal fiscal year, e.g., 
as cash, discounts, waivers, and in-kind; the benefits provided to low-
income households by these resources, for example, as fuel and payments 
for fuel, as home heating and cooling equipment, and as weatherization 
materials and installation; and the fair market value of these 
resources/benefits.
    HHS needs this information in order to carry out federal statutory 
requirements for administering the LIHEAP leveraging incentive program, 
to determine accountability and valuation of grantees' leveraged non-
federal home energy resources, and to determine grantees' shares of 
leveraging incentive funds. HHS proposes to request a three-year 
clearance by OMB for the LIHEAP leveraging report information 
collection which has received OMB approval in the past. Respondents: 
State, Local or Tribal Governments.

[[Page 18858]]



                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
                 Instrument                      Number of      responses per      hours  per      Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
LIHEAP Leveraging Report....................              70                1               38            2,660
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 2,660.
    In compliance with the requirements of Section 506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Planning, Research and Evaluation, 330 C Street SW., Washington DC 
20201. Attn: ACF Reports Clearance Officer. Email address: 
infocollection@acf.hhs.gov. All requests should be identified by the 
title of the information collection.
    The Department specifically requests comments on: (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) the quality, utility, and clarity of the information 
to be collected; and (d) ways to minimize the burden of the collection 
of information on respondents, including through the use of automated 
collection techniques or other forms of information technology. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016-07359 Filed 3-31-16; 8:45 am]
 BILLING CODE 4184-01-P