Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 41025 

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

Instrument 

Total number 

of 

respondents 

Annual 

number 

of respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Annual 

burden hours 

Baseline data collection—study participants ....................... 6,000 2,000 1 0.33 660 

Baseline data collection—staff ............................................. 60 20 100 0.33 660 

First follow-up survey ........................................................... 2,400 800 1 1 800 

Semi-structured staff interviews ........................................... 66 22 1 1.5 33 

Staff survey .......................................................................... 48 16 1 0.75 12 

In-depth participant interviews ............................................. 24 8 1 2.5 20 

Staff reports of program service receipt .............................. 30 10 5,200 0.03 1,560 

Video recordings of coaching sessions ............................... 27 9 10 0.10 9 

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: 

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 

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 


sradovich on DSK3GMQ082PROD with NOTICES
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. 

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) 

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: 

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 

($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. 

II. Fee Revenue Amount for FY 2018 

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. 

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 


sradovich on DSK3GMQ082PROD with NOTICES