Submission for OMB Review; Comment Request, 41025-41026 [2017-18254]
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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
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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
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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
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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 (https://
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.
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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
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]]>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]
-----------------------------------------------------------------------
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
