82 FR 41025 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 82, Issue 166 (August 29, 2017)

Page Range		41025-41026
FR Document		2017-18254

Federal Register, Volume 82 Issue 166 (Tuesday, August 29, 2017)

[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Pages 41025-41026]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18254]


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

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: 
[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: 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

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

move toward self-sufficiency, and The proposed information collection Collection of data on coaching and other
improve their overall well-being. To activities are: (1) Baseline data program services received by study
meet these objectives, this study will collection: Collection of characteristics participants and entered into RAPTER;
include an impact and implementation data on all study participants as they and (7) Video recordings of coaching
study. enroll in the study. Data will be entered sessions: Collection of data on the
The impact study will involve into the Random Assignment, interaction between the coaches and
participants being randomly assigned to Participant Tracking Enrollment, and participants.
Reporting (RAPTER) system; (2) First
either a ‘‘program group,’’ who will be A second follow-up survey will be
follow-up survey: Collection of outcome
paired with a coach, or to a ‘‘control administered approximately 21 months
data for a subset of study participants
group,’’ who will not be paired with a after random assignment. This data
about 9 months after random
coach. The effectiveness of the coaching collection activity will be included
assignment; (3) Semi-structured staff
will be determined by differences under a separate OMB submission.
interviews: Collection of qualitative data
between members of the program and on the design and implementation of the Respondents: Program staff and
control groups in outcomes such as program; (4) Staff survey: Collection of individuals enrolled in the Evaluation
obtaining and retaining employment, information on staff members’ of Employment Coaching for TANF and
earnings, measures of self-sufficiency, professional backgrounds, training, Other Low-Income Populations.
and measures of self-regulation. coaching practices, and attitudes; (5) In- Program staff may include coaches, case
The implementation study will depth participant interviews: Collection managers, workshop instructors, job
document coaching practices, describe of detailed information about the developers, supervisors, and managers.
lessons learned from implementing participants’ backgrounds and All participants will be able to opt out
coaching, and enhance interpretation of experiences with coaching; (6) Staff of participating in the data collection
the impact study findings. reports of program service receipt: activities.

ANNUAL BURDEN ESTIMATES
Number of Average
Total number Annual responses burden Annual
Instrument of number per hours per burden hours
respondents of respondents respondent response

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 Desk Officer for the Administration for program, estimates of the projected costs
Hours: 3,754. Children and Families. they anticipate incurring in providing
Additional Information: Copies of the cash and medical assistance for eligible
Mary Jones,
proposed collection may be obtained by recipients and the costs of administering
ACF/OPRE Certifying Officer. the program. Under the CMA program,
writing to the Administration for [FR Doc. 2017–18226 Filed 8–28–17; 8:45 am] States are reimbursed for the costs of
Children and Families, Office of BILLING CODE 4184–09–P providing these services and benefits for
Planning, Research and Evaluation, 330
eight months after an eligible recipient
C Street SW., Washington, DC 20201, arrives in this country. The eligible
Attn: OPRE Reports Clearance Officer. DEPARTMENT OF HEALTH AND recipients for these services and benefits
All requests should be identified by the HUMAN SERVICES are refugees, Amerasians, Cuban and
title of the information collection. Email Haitian Entrants, asylees, Afghans and
address: OPREinfocollection@ Administration for Children and
Families Iraqi with Special Immigrant Visas, and
acf.hhs.gov. victims of a severe form of trafficking.
OMB Comment: OMB is required to Submission for OMB Review; States that provide services for
make a decision concerning the Comment Request unaccompanied refugee minors also
collection of information between 30 provide an estimate for the cost of these
and 60 days after publication of this Title: Refugee Assistance Program services for the year for which they are
document in the Federal Register. Estimates: CMA–ORR–1. applying for grants.
Therefore, a comment is best assured of OMB No.: 0970–0030. ORR proposes streamlining language
having its full effect if OMB receives it Description: The ORR–1, Cash and to make the instructions easier to read.
Medical Assistance (CMA) Program ORR proposes adding language for
sradovich on DSK3GMQ082PROD with NOTICES

within 30 days of publication. Written
comments and recommendations for the Estimates, is the application for grants clarification and consistency across
under the CMA program. The programs. Additionally, ORR proposes
proposed information collection should
application is required by the Office of to require states to submit copies of
be sent directly to the following: Office
Refugee Resettlement (ORR) program their contracts with URM providers
of Management and Budget, Paperwork
regulations at 45 CFR 400.11(b). The with the submission.
Reduction Project, Email: OIRA_ regulation specifies that States must Respondents: State Agencies, the
SUBMISSION@OMB.EOP.GOV. Attn: submit, as their application for this District of Columbia, Replacement

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41026 Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices

Designees under 45 CFR 400.301(c), and administration of programs under Title
Wilson-Fish Grantees (State 2 Agencies) IV of the Act.
administering or supervising the

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

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

Estimated Total Annual Burden facilities, finished dosage form (FDF) ($47,829), domestic API facility
Hours: 33. facilities, contract manufacturing ($45,367), foreign API facility ($60,367),
Copies of the proposed collection may organization (CMO) facilities, and domestic FDF facility ($211,087),
be obtained by writing to the generic drug applicant program user foreign FDF facility ($226,087),
Administration for Children and fees. In this document the Food and domestic CMO facility ($70,362), foreign
Families, Office of Planning, Research Drug Administration (FDA or Agency) is CMO facility ($85,362), large size
and Evaluation, 330 C Street SW., announcing fiscal year (FY) 2018 rates operation generic drug applicant
Washington, DC 20201. Attention for GDUFA fees. program ($1,590,792), medium size
Reports Clearance Officer. All requests FOR FURTHER INFORMATION CONTACT: operation drug applicant program
should be identified by the title of the David Haas, Office of Financial ($636,317), and small business generic
information collection. Email address: Management, Food and Drug drug applicant program ($159,079).
infocollection@acf.hhs.gov. Administration, 8455 Colesville Rd., These fees are effective on October 1,
OMB Comment: OMB is required to COLE–14202I, Silver Spring, MD 2017, and will remain in effect through
make a decision concerning the 20993–0002, 240–402–9845. September 30, 2018.
collection of information between 30 SUPPLEMENTARY INFORMATION:
and 60 days after publication of this II. Fee Revenue Amount for FY 2018
document in the Federal Register. I. Background The base revenue amount for FY 2018
Therefore, a comment is best assured of Sections 744A and 744B of the FD&C is $493,600,000, as set in the statute (see
having its full effect if OMB receives it Act (21 U.S.C. 379j–41 and 379j–42) section 744B(b)(1) of the FD&C Act).
within 30 days of publication. Written establish fees associated with human GDUFA II directs FDA to use the yearly
comments and recommendations for the generic drug products. Fees are assessed revenue amount as a starting point to set
proposed information collection should on: (1) Certain types of applications for the fee rates for each fee type. For more
be sent directly to the following: Office human generic drug products; (2) information about GDUFA II, please
of Management and Budget, Paperwork certain facilities where APIs and FDFs refer to the FDA Web site (http://
Reduction Project, Email: OIRA_ are produced; (3) certain DMFs www.fda.gov/gdufa). The ANDA, DMF,
SUBMISSION@OMB.EOP.GOV, Attn: associated with human generic drug API facility, FDF facility, CMO facility,
Desk Officer for the Administration for products; and (4) the generic drug and generic drug applicant program fee
Children and Families. applicant program (see section (GDUFA Program Fee) calculations for
Robert Sargis, 744B(a)(1)–(5) of the FD&C Act). FY 2018 are described in this document.
GDUFA II fees vary greatly from those GDUFA II specifies that the
Reports Clearance Officer.
in GDUFA I because of two fundamental $493,600,000 is to be adjusted for
[FR Doc. 2017–18254 Filed 8–28–17; 8:45 am]
adjustments to the fee structure: inflation increases for FY 2019 through
BILLING CODE 4184–45–P FY 2022 using two separate
(1) The revenue base for GDUFA II is
$493.6 million versus $323 million in adjustments—one for personnel
the final year of GDUFA I—ANDAs are compensation and benefits (PC&B) and
DEPARTMENT OF HEALTH AND one for non-PC&B costs (see section
the primary workload driver of the
HUMAN SERVICES 744B(c)(1) of the FD&C Act). Because
program. GDUFA I was built on the
Food and Drug Administration assumption that FDA would receive 750 the adjustment for inflation does not
ANDAs per year. Over the first 4 years take effect until FY 2019, FDA will not
[Docket No. FDA–2016–N–0007] of GDUFA I, ANDA receipts have adjust the base revenue amount for
averaged approximately 1,000 per year. inflation in FY 2018.
Generic Drug User Fee Rates for Fiscal
To address the increased workload, FDA III. ANDA Fee
Year 2018
hired additional staff and is projected to
AGENCY: Food and Drug Administration, spend about $430 million in the final Under GDUFA II, the FY 2018 ANDA
HHS. year of GDUFA I. To maintain FDA’s fee is owed by each applicant that
ACTION: Notice. current productivity and implement submits an ANDA on or after October 1,
negotiated improvements, GDUFA II 2017. This fee is due on the receipt date
SUMMARY: The Federal Food, Drug, and stipulates that user fees should total of the ANDA. Section 744B(b)(2)(B)
Cosmetic Act (the FD&C Act), as specifies that the ANDA fee will make
sradovich on DSK3GMQ082PROD with NOTICES

$493.6 million annually adjusted each
amended by the Generic Drug User Fee year for inflation. up 33 percent of the $493,600,000,
Amendments of 2017 (GDUFA II), (2) GDUFA II will for the first time which is $162,888,000.
authorizes FDA to assess and collect rely on annual program fees—GDUFA II To calculate the ANDA fee, FDA
fees for abbreviated new drug shifts the fee burden somewhat from estimated the number of full application
applications (ANDAs), drug master files facility fees. equivalents (FAEs) that will be
(DMFs), generic drug active For FY 2018, the generic drug fee submitted in FY 2018. An ANDA counts
pharmaceutical ingredient (API) rates are: ANDA ($171,823), DMF as one FAE; however, 75 percent of the

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Document Created: 2017-08-29 01:58:24
Document Modified: 2017-08-29 01:58:24

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
FR Citation		82 FR 41025

82 FR 41025 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 82, Issue 166 (August 29, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families