Submission for OMB Review; Comment Request, 41025-41026 [2017-18254]

Download as PDF 41025 Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices move toward self-sufficiency, and improve their overall well-being. To meet these objectives, this study will include an impact and implementation study. The impact study will involve participants being randomly assigned to either a ‘‘program group,’’ who will be paired with a coach, or to a ‘‘control group,’’ who will not be paired with a coach. The effectiveness of the coaching will be determined by differences between members of the program and control groups in outcomes such as obtaining and retaining employment, earnings, measures of self-sufficiency, and measures of self-regulation. The implementation study will document coaching practices, describe lessons learned from implementing coaching, and enhance interpretation of the impact study findings. The proposed information collection activities are: (1) Baseline data collection: Collection of characteristics data on all study participants as they enroll in the study. Data will be entered into the Random Assignment, Participant Tracking Enrollment, and Reporting (RAPTER) system; (2) First follow-up survey: Collection of outcome data for a subset of study participants about 9 months after random assignment; (3) Semi-structured staff interviews: Collection of qualitative data on the design and implementation of the program; (4) Staff survey: Collection of information on staff members’ professional backgrounds, training, coaching practices, and attitudes; (5) Indepth participant interviews: Collection of detailed information about the participants’ backgrounds and experiences with coaching; (6) Staff reports of program service receipt: Collection of data on coaching and other program services received by study participants and entered into RAPTER; and (7) Video recordings of coaching sessions: Collection of data on the interaction between the coaches and participants. A second follow-up survey will be administered approximately 21 months after random assignment. This data collection activity will be included under a separate OMB submission. Respondents: Program staff and individuals enrolled in the Evaluation of Employment Coaching for TANF and Other Low-Income Populations. Program staff may include coaches, case managers, workshop instructors, job developers, supervisors, and managers. All participants will be able to opt out of participating in the data collection activities. ANNUAL BURDEN ESTIMATES Total number of respondents Instrument sradovich on DSK3GMQ082PROD with NOTICES Baseline data collection—study participants ....................... Baseline data collection—staff ............................................. First follow-up survey ........................................................... Semi-structured staff interviews ........................................... Staff survey .......................................................................... In-depth participant interviews ............................................. Staff reports of program service receipt .............................. Video recordings of coaching sessions ............................... Estimated Total Annual Burden Hours: 3,754. 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: VerDate Sep<11>2014 18:45 Aug 28, 2017 Jkt 241001 Annual number of respondents 6,000 60 2,400 66 48 24 30 27 2,000 20 800 22 16 8 10 9 Desk Officer for the Administration for Children and Families. Mary Jones, ACF/OPRE Certifying Officer. [FR Doc. 2017–18226 Filed 8–28–17; 8:45 am] BILLING CODE 4184–09–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Refugee Assistance Program Estimates: CMA–ORR–1. OMB No.: 0970–0030. Description: The ORR–1, Cash and Medical Assistance (CMA) Program Estimates, is the application for grants under the CMA program. The application is required by the Office of Refugee Resettlement (ORR) program regulations at 45 CFR 400.11(b). The regulation specifies that States must submit, as their application for this PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 100 1 1 1 1 5,200 10 Average burden hours per response 0.33 0.33 1 1.5 0.75 2.5 0.03 0.10 Annual burden hours 660 660 800 33 12 20 1,560 9 program, estimates of the projected costs they anticipate incurring in providing cash and medical assistance for eligible recipients and the costs of administering the program. Under the CMA program, States are reimbursed for the costs of providing these services and benefits for eight months after an eligible recipient arrives in this country. The eligible recipients for these services and benefits are refugees, Amerasians, Cuban and Haitian Entrants, asylees, Afghans and Iraqi with Special Immigrant Visas, and victims of a severe form of trafficking. States that provide services for unaccompanied refugee minors also provide an estimate for the cost of these services for the year for which they are applying for grants. ORR proposes streamlining language to make the instructions easier to read. ORR proposes adding language for clarification and consistency across programs. Additionally, ORR proposes to require states to submit copies of their contracts with URM providers with the submission. Respondents: State Agencies, the District of Columbia, Replacement E:\FR\FM\29AUN1.SGM 29AUN1 41026 Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 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 Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ORR–1, Cash and Medical Assistance Program Estimates ........................... 55 1 0.60 33 Estimated Total Annual Burden Hours: 33. 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. 2017–18254 Filed 8–28–17; 8:45 am] BILLING CODE 4184–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0007] Generic Drug User Fee Rates for Fiscal Year 2018 AGENCY: Food and Drug Administration, HHS. sradovich on DSK3GMQ082PROD with NOTICES ACTION: Notice. SUMMARY: The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) VerDate Sep<11>2014 18:45 Aug 28, 2017 Jkt 241001 facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document the Food and Drug Administration (FDA or Agency) is announcing fiscal year (FY) 2018 rates for GDUFA fees. FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14202I, Silver Spring, MD 20993–0002, 240–402–9845. SUPPLEMENTARY INFORMATION: ($47,829), domestic API facility ($45,367), foreign API facility ($60,367), domestic FDF facility ($211,087), foreign FDF facility ($226,087), domestic CMO facility ($70,362), foreign CMO facility ($85,362), large size operation generic drug applicant program ($1,590,792), medium size operation drug applicant program ($636,317), and small business generic drug applicant program ($159,079). These fees are effective on October 1, 2017, and will remain in effect through September 30, 2018. I. Background Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j–41 and 379j–42) establish fees associated with human generic drug products. Fees are assessed on: (1) Certain types of applications for human generic drug products; (2) certain facilities where APIs and FDFs are produced; (3) certain DMFs associated with human generic drug products; and (4) the generic drug applicant program (see section 744B(a)(1)–(5) of the FD&C Act). GDUFA II fees vary greatly from those in GDUFA I because of two fundamental adjustments to the fee structure: (1) The revenue base for GDUFA II is $493.6 million versus $323 million in the final year of GDUFA I—ANDAs are the primary workload driver of the program. GDUFA I was built on the assumption that FDA would receive 750 ANDAs per year. Over the first 4 years of GDUFA I, ANDA receipts have averaged approximately 1,000 per year. To address the increased workload, FDA hired additional staff and is projected to spend about $430 million in the final year of GDUFA I. To maintain FDA’s current productivity and implement negotiated improvements, GDUFA II stipulates that user fees should total $493.6 million annually adjusted each year for inflation. (2) GDUFA II will for the first time rely on annual program fees—GDUFA II shifts the fee burden somewhat from facility fees. For FY 2018, the generic drug fee rates are: ANDA ($171,823), DMF The base revenue amount for FY 2018 is $493,600,000, as set in the statute (see section 744B(b)(1) of the FD&C Act). GDUFA II directs FDA to use the yearly revenue amount as a starting point to set the fee rates for each fee type. For more information about GDUFA II, please refer to the FDA Web site (http:// www.fda.gov/gdufa). The ANDA, DMF, API facility, FDF facility, CMO facility, and generic drug applicant program fee (GDUFA Program Fee) calculations for FY 2018 are described in this document. GDUFA II specifies that the $493,600,000 is to be adjusted for inflation increases for FY 2019 through FY 2022 using two separate adjustments—one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 744B(c)(1) of the FD&C Act). Because the adjustment for inflation does not take effect until FY 2019, FDA will not adjust the base revenue amount for inflation in FY 2018. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 II. Fee Revenue Amount for FY 2018 III. ANDA Fee Under GDUFA II, the FY 2018 ANDA fee is owed by each applicant that submits an ANDA on or after October 1, 2017. This fee is due on the receipt date of the ANDA. Section 744B(b)(2)(B) specifies that the ANDA fee will make up 33 percent of the $493,600,000, which is $162,888,000. To calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2018. An ANDA counts as one FAE; however, 75 percent of the E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Pages 41025-41026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Refugee Assistance Program Estimates: CMA-ORR-1.
    OMB No.: 0970-0030.
    Description: The ORR-1, Cash and Medical Assistance (CMA) Program 
Estimates, is the application for grants under the CMA program. The 
application is required by the Office of Refugee Resettlement (ORR) 
program regulations at 45 CFR 400.11(b). The regulation specifies that 
States must submit, as their application for this program, estimates of 
the projected costs they anticipate incurring in providing cash and 
medical assistance for eligible recipients and the costs of 
administering the program. Under the CMA program, States are reimbursed 
for the costs of providing these services and benefits for eight months 
after an eligible recipient arrives in this country. The eligible 
recipients for these services and benefits are refugees, Amerasians, 
Cuban and Haitian Entrants, asylees, Afghans and Iraqi with Special 
Immigrant Visas, and victims of a severe form of trafficking. States 
that provide services for unaccompanied refugee minors also provide an 
estimate for the cost of these services for the year for which they are 
applying for grants.
    ORR proposes streamlining language to make the instructions easier 
to read. ORR proposes adding language for clarification and consistency 
across programs. Additionally, ORR proposes to require states to submit 
copies of their contracts with URM providers with the submission.
    Respondents: State Agencies, the District of Columbia, Replacement

[[Page 41026]]

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-1, Cash and Medical Assistance Program                55                1             0.60               33
 Estimates..................................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 33.
    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. 2017-18254 Filed 8-28-17; 8:45 am]
 BILLING CODE 4184-45-P