Submission for OMB Review; Comment Request, 6573-6574 [2018-03091]

Download as PDF Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices BILLING CODE 4163–19–C published on the NIOSH website and announced in a Federal Register notice. X. Drugs Removed From the NIOSH List of Hazardous Drugs In a petition to NIOSH in February 2017, the pharmaceutical company Theravance Biopharma requested the removal of the drug telavancin from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.22 The petition included an analysis of animal developmental toxicity studies and argued that ‘‘[p]lacing telavancin in the NIOSH category of a hazardous drug greatly overstates the occupational risk to healthcare workers handling telavancin.’’ In response, NIOSH evaluated the information provided in the petition as well as other sources provided to NIOSH by the manufacturer and determined that telavancin does not meet the NIOSH definition of a hazardous drug. NIOSH informed users of the 2016 List of this determination via a web posting and responded to Theravance Biopharma with a letter dated April 12, 2017.23 Accordingly, telavancin does not appear in the 2018 update to the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. This decision is considered final. XI. Final List of Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs After consideration of all public comments received in the docket for this action, NIOSH will develop a final list of drugs to be placed on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018. The 2018 Update will be Dated: February 8, 2018. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2018–02957 Filed 2–13–18; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Office of Refugee Resettlement Cash and Medical Assistance Program Quarterly Report on Expenditures and Obligations. OMB No.: 0970–0407. Description: The Office of Refugee Resettlement (ORR) reimburses, to the extent of available appropriations, certain non-federal costs for the provision of cash and medical assistance to refugees and other eligible persons, along with allowable expenses for the administration of the refugee resettlement program at the State level. States, Wilson/Fish projects (alternative projects for the administration of the refugee resettlement program), and State Replacement Designees currently submit the ORR–2 Financial Status Report in accordance with 45 CFR part 92 and 45 CFR part 74. This proposed data collection would collect financial status data (i.e., amounts of expenditures and obligations) broken down by the four program components: 6573 Refugee cash assistance, refugee medical assistance, health screening, and services for unaccompanied refugee minors as well as by program administration. This breakdown of financial status data on expenditures and obligations allows ORR to track program expenditures in greater detail to anticipate any funding issues and to meet the requirements of ORR regulations at 45 CFR 400.211 to collect these data for use in estimating annual costs of the refugee resettlement program. ORR must implement the methodology at 45 CFR 400.211 each year after receipt of its annual appropriation to ensure that the appropriated funds will be adequate for assistance to entering refugees. The estimating methodology prescribed in the ORR regulations requires the use of actual past costs by program component. In the event that the methodology indicates that appropriated funds are inadequate, ORR must take steps to reduce federal expenses, such as by limiting the number of months of eligibility for Refugee Cash Assistance and Refugee Medical Assistance. This proposed single-page report on expenditures and obligations will allow ORR to collect the necessary data to ensure that funds are adequate for the projected need and thereby meet the requirements of both the Refugee Act and ORR regulations. Respondents: State Agencies, the District of Columbia, Replacement Designees under 45 CFR 400.301(c), and Wilson-Fish Grantees (State 2 Agencies) administering or supervising the administration of programs under Title IV of the Act. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ORR Financial Status Report Cash and Medical Assistance Program, Quarterly Report on Expenditures and Obligations ............................................. daltland on DSKBBV9HB2PROD with NOTICES Instrument 57 4 1.50 342 Estimated Total Annual Burden Hours: 342. 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: 22 Harstad EB and Coleman R. Petition of Theravance Biopharma US, Inc. to Remove Telavancin from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. February 28, 2017. 23 NIOSH letter to Eric Harstad and Rebecca Coleman. April 12, 2017. VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1 6574 Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2018–03091 Filed 2–13–18; 8:45 am] BILLING CODE 4184–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Home Visiting Career Trajectories. OMB No.: New Collection. Description: The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS), in collaboration with the Health Resources and Services Administration (HRSA), seeks approval to collect information from home visiting program staff in programs receiving funding through the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program as part of the Home Visiting Career Trajectories study. ACF is interested in collecting information about the state of the home visiting workforce, career trajectories of home visitors, and strategies for building a pipeline of qualified home visitors and supervisors. Through the proposed information collection, the researchers will obtain information about the characteristics, qualifications, and career trajectories of home visiting staff. The study will include a national survey of the MIECHV workforce, interviews with training and technical assistance experts, and site visits to home visiting programs in eight states that vary in terms of geography, population demographics, labor markets, and home visiting program offerings. Respondents: Home visiting program managers, supervisors, home visitors, and training and technical assistance experts. ANNUAL BURDEN ESTIMATES Total/annual number of respondents Instrument daltland on DSKBBV9HB2PROD with NOTICES Home visitor and supervisor survey ................................................................ Program manager survey ................................................................................ Focus group moderator’s guide ....................................................................... Self-administered questionnaire for focus group participants ......................... Key informant interview guide—management and supervisory staff .............. Key informant interview guide—training and technical assistance experts .... Estimated Total Annual Burden Hours: 2,510. Additional Information: 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, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@ 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. Mary Jones, ACF/OPRE Certifying Officer. [FR Doc. 2018–03093 Filed 2–13–18; 8:45 am] BILLING CODE 4184–74–P VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 3,000 700 480 480 80 30 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–E–2336] Determination of Regulatory Review Period for Purposes of Patent Extension; JUVEDERM VOLUMA XC AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for JUVEDERM VOLUMA XC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 1 1 1 1 Average burden hours per response 0.38 0.33 2 0.03 1.5 1.5 Annual burden hours 1,140 231 960 14 120 45 You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6573-6574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03091]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Office of Refugee Resettlement Cash and Medical Assistance 
Program Quarterly Report on Expenditures and Obligations.
    OMB No.: 0970-0407.
    Description: The Office of Refugee Resettlement (ORR) reimburses, 
to the extent of available appropriations, certain non-federal costs 
for the provision of cash and medical assistance to refugees and other 
eligible persons, along with allowable expenses for the administration 
of the refugee resettlement program at the State level. States, Wilson/
Fish projects (alternative projects for the administration of the 
refugee resettlement program), and State Replacement Designees 
currently submit the ORR-2 Financial Status Report in accordance with 
45 CFR part 92 and 45 CFR part 74. This proposed data collection would 
collect financial status data (i.e., amounts of expenditures and 
obligations) broken down by the four program components: Refugee cash 
assistance, refugee medical assistance, health screening, and services 
for unaccompanied refugee minors as well as by program administration. 
This breakdown of financial status data on expenditures and obligations 
allows ORR to track program expenditures in greater detail to 
anticipate any funding issues and to meet the requirements of ORR 
regulations at 45 CFR 400.211 to collect these data for use in 
estimating annual costs of the refugee resettlement program. ORR must 
implement the methodology at 45 CFR 400.211 each year after receipt of 
its annual appropriation to ensure that the appropriated funds will be 
adequate for assistance to entering refugees. The estimating 
methodology prescribed in the ORR regulations requires the use of 
actual past costs by program component. In the event that the 
methodology indicates that appropriated funds are inadequate, ORR must 
take steps to reduce federal expenses, such as by limiting the number 
of months of eligibility for Refugee Cash Assistance and Refugee 
Medical Assistance. This proposed single-page report on expenditures 
and obligations will allow ORR to collect the necessary data to ensure 
that funds are adequate for the projected need and thereby meet the 
requirements of both the Refugee Act and ORR regulations.
    Respondents: State Agencies, the District of Columbia, Replacement 
Designees under 45 CFR 400.301(c), and Wilson-Fish Grantees (State 2 
Agencies) administering or supervising the administration of programs 
under Title IV of the Act.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ORR Financial Status Report Cash and Medical              57                4             1.50              342
 Assistance Program, Quarterly Report on
 Expenditures and Obligations...............
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 342.
    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: 
[email protected].
    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: 
[email protected], Attn:

[[Page 6574]]

Desk Officer for the Administration for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018-03091 Filed 2-13-18; 8:45 am]
 BILLING CODE 4184-45-P