Submission for OMB Review; Native Employment Works (NEW) Program Plan Guidance and Report Requirements, (OMB No.: 970-0174), 36100-36101 [2019-15909]
Download as PDF
<![CDATA[
36100
Federal Register / Vol. 84, No. 144 / Friday, July 26, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Establishment of
Exchanges and Qualified Health Plans;
Use: As directed by the Establishment of
Exchanges and Qualified Health Plans;
Exchange Standards for Employers (77
FR 18310) final rule, each Exchange
assumed responsibilities related to the
certification and offering of QHPs.
Under 45 CFR 156.280(e)(5)(ii), each
QHP issuer that offers non-excepted
abortion services must submit to the
State Insurance Commissioner a
segregation plan describing how the
QHP issuer establishes and maintains
separate payment accounts for any QHP
covering non-excepted abortion
services, and pursuant to
§ 156.280(e)(5)(iii), each QHP issuer
must annually attest to compliance with
PPACA section 1303 and applicable
regulations. This segregation plan is
used to verify that the QHP issuer’s
financial and other systems fully
conform to the segregation requirements
required by the PPACA.
The Centers for Medicare and
Medicaid Services (CMS) is renewing
this information collection request (ICR)
in connection with the segregation plan
requirement under 45 CFR
156.280(e)(5)(ii). The burden estimate
for this ICR included in this renewal
package reflects the time and effort for
QHP issuers to submit a segregation
plan that demonstrates how the QHP
issuer segregates QHP funds in
accordance with applicable provisions
of generally accepted accounting
requirements, circulars on funds
management of the Office of
Management and Budget and guidance
on accounting of the Government
Accountability Office. CMS is also
renewing the ICR in connection with the
annual attestation requirement under 45
CFR 156.280(e)(5)(iii). The burden
estimate for this ICR reflects the time
and effort associated with QHP issuers
submitting an annual attestation to the
State Insurance Commissioner attesting
to compliance with section 1303 of the
PPACA. Form Number: CMS–10400
(OMB control number: 0938–1156);
Frequency: Annually; Affected Public:
Private Sector (business or other for-
VerDate Sep<11>2014
18:59 Jul 25, 2019
Jkt 247001
profits, not-for-profit institutions);
Number of Respondents: 210; Number
of Responses: 210; Total Annual Hours:
580. (For questions regarding this
collection contact Michele Oshman at
410–786–4396).
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: QHP Issuers
Data Collection for Notices for Plan or
Display Errors Special Enrollment
Periods; Use: The Patient Protection and
Affordable Care Act (Pub. L. 111–148)
and Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152), collectively referred to as the
PPACA, established new competitive
private health insurance markets called
Marketplaces, or Exchanges, which gave
millions of Americans and small
businesses access to qualified health
plans (QHPs), including stand-alone
dental plans (SADPs)— private health
and dental insurance plans that have
been certified as meeting certain
standards.
In the final rule, the Patient Protection
and Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for
2017 (CMS–9937–F), we finalized 45
CFR 156.1256, which requires QHP
issuers, in the case of a material plan or
benefit display error included in 45 CFR
155.420(d)(12), to notify their enrollees
of the error and the enrollees’ eligibility
for a special enrollment period (SEP)
within 30 calendar days after the issuer
is informed by an Federally-facilitated
Exchange (FFE) that the error is
corrected, if directed to do so by the
FFE. This requirement provides
notification to QHP enrollees of errors
that may have impacted their QHP
selection and enrollment and any
associated monthly or annual costs, as
well as the availability of an SEP under
§ 155.420(d)(12) for the enrollee to
select a different QHP, if desired. The
Centers for Medicare and Medicaid
Services (CMS) is renewing this
information collection request (ICR) in
connection with standards regarding
Plan or Display Errors SEPs. Form
Number: CMS–10595 (OMB control
number: 0938–1301); Frequency: Yearly;
Affected Public: Private Sector (business
or other for-profits, not-for-profit
institutions); Number of Respondents:
505; Total Annual Responses: 3,400;
Total Annual Hours: 1,700. (For
questions regarding this collection
contact Deborah Hunter at 202–309–
1098).
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Dated: July 23, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–15917 Filed 7–25–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Native
Employment Works (NEW) Program
Plan Guidance and Report
Requirements, (OMB No.: 970–0174)
Division of Tribal TANF
Management, Office of Family
Assistance, Administration for Children
and Families; HHS.
ACTION: Request for public comment.
AGENCY:
SUMMARY: The Administration for
Children and Families (ACF) is
requesting a three-year extension of the
form OFA–0086, NEW Plan Guidance
and NEW Program Report (OMB #0970–
0174, expiration 7/31/2019). There are
changes requested to these forms.
DATES: Comments due within 30 days of
publication. 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.
ADDRESSES:
Copies of the proposed collection may
be obtained by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also 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,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The NEW program plan
guidance documents specify the
information needed to complete a NEW
program plan and explains the process
E:\FR\FM\26JYN1.SGM
26JYN1
36101
Federal Register / Vol. 84, No. 144 / Friday, July 26, 2019 / Notices
for plan submission every third year and
to complete the annual program report.
The program plan is the application for
NEW program funding and documents
how the grantee will carry out its NEW
program. The program report provides
HHS, Congress, and grantees
information to document and assess the
activities and accomplishments of the
NEW program. ACF proposes to extend
data collection with revisions, including
the deletion of guidance for NEW
programs included in Public Law 102–
477 programs.
Respondents: Indian tribes and tribal
coalitions that run NEW programs.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
NEW program plan guidance for non-477 Tribes ...........................................
NEW program report .......................................................................................
Number of
responses per
respondent
1 14
1
1
2 42
Average
burden hours
per response
29
15
Annual
burden hours
406
630
1 We estimate that 42 of the 78 NEW grantees will not include their NEW programs in Public Law 102–477 projects. 42 grantees divided by 3
(because grantees submit the NEW plan once every 3 years) = 14.
2 We estimate that 42 of the 78 NEW grantees will not include their NEW programs in Public Law 102–477 projects and therefore will submit
the NEW program report to HHS.
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 61075, Beltsville, MD 20705–4304,
240–402–4585.
SUPPLEMENTARY INFORMATION:
Estimated Total Annual Burden
Hours: 1036 3
Authority: 42 U.S.C. 612.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–15909 Filed 7–25–19; 8:45 am]
BILLING CODE 4184–36–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 2020
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY: The Federal Food, Drug, and
Cosmetic Act (FD&C Act or statute), as
amended by the Generic Drug User Fee
Amendments of 2017 (GDUFA II),
authorizes the Food and Drug
Administration (FDA, Agency, or we) 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, FDA is
announcing fiscal year (FY) 2020 rates
for GDUFA II fees.
FOR FURTHER INFORMATION CONTACT:
Melissa Hurley, Office of Financial
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) generic drug
applicants who have approved ANDAs
(the program fee) (see section 744B(a)(2)
to (5) of the FD&C Act).
GDUFA II stipulates that user fees
should total $493,600,000 annually
adjusted each year for inflation. For FY
2020, the generic drug fee rates are:
ANDA ($176,237), DMF ($57,795),
domestic API facility ($44,400), foreign
API facility ($59,400), domestic FDF
facility ($195,662), foreign FDF facility
($210,662), domestic CMO facility
($65,221), foreign CMO facility
($80,221), large size operation generic
drug applicant program ($1,661,684),
medium size operation generic drug
applicant program ($664,674), and small
business generic drug applicant program
($166,168). These fees are effective on
October 1, 2019, and will remain in
effect through September 30, 2020.
II. Fee Revenue Amount for FY 2020
GDUFA II directs FDA to use the
yearly revenue amount determined
under the statute as a starting point to
set the fee rates for each fee type. For
more information about GDUFA II,
please refer to the FDA website (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 2020 are described in this document.
The base revenue amount for FY 2020
is $501,721,201. This is the amount
calculated for the prior fiscal year, FY
2019, pursuant to the statute (see
section 744B(b)(1) of the FD&C Act).
GDUFA II specifies that the
$501,721,201 is to be adjusted for
inflation increases for FY 2020 using
two separate adjustments—one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see
sections 744B(c)(1)(B) and (C) of the
FD&C Act).
The component of the inflation
adjustment for PC&B costs shall be one
plus the average annual percent change
in the cost of all PC&B paid per full-time
equivalent position (FTE) at FDA for the
first 3 of the 4 preceding fiscal years,
multiplied by the proportion of PC&B
costs to total FDA costs of human
generic drug activities for the first 3 of
the preceding 4 fiscal years (see section
744B(c)(1)(B) of the FD&C Act).
Table 1 summarizes the actual cost
and total FTEs for the specified fiscal
years, and provides the percent change
from the previous fiscal year and the
average percent change over the first 3
of the 4 fiscal years preceding FY 2020.
The 3-year average is 3.1175 percent.
3 Two additional programs joined the Public Law
102–477 since the publication of FR1, hence the
burden is different.
VerDate Sep<11>2014
17:54 Jul 25, 2019
Jkt 247001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36100-36101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15909]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Native Employment Works (NEW) Program
Plan Guidance and Report Requirements, (OMB No.: 970-0174)
AGENCY: Division of Tribal TANF Management, Office of Family
Assistance, Administration for Children and Families; HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) is
requesting a three-year extension of the form OFA-0086, NEW Plan
Guidance and NEW Program Report (OMB #0970-0174, expiration 7/31/2019).
There are changes requested to these forms.
DATES: Comments due within 30 days of publication. 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.
ADDRESSES: 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.
Copies of the proposed collection may be obtained by emailing
[email protected]. Alternatively, copies can also 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, emailed or
written, should be identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The NEW program plan guidance documents specify the
information needed to complete a NEW program plan and explains the
process
[[Page 36101]]
for plan submission every third year and to complete the annual program
report. The program plan is the application for NEW program funding and
documents how the grantee will carry out its NEW program. The program
report provides HHS, Congress, and grantees information to document and
assess the activities and accomplishments of the NEW program. ACF
proposes to extend data collection with revisions, including the
deletion of guidance for NEW programs included in Public Law 102-477
programs.
Respondents: Indian tribes and tribal coalitions that run NEW
programs.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Annual burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
NEW program plan guidance for non-477 Tribes.... \1\ 14 1 29 406
NEW program report.............................. \2\ 42 1 15 630
----------------------------------------------------------------------------------------------------------------
\1\ We estimate that 42 of the 78 NEW grantees will not include their NEW programs in Public Law 102-477
projects. 42 grantees divided by 3 (because grantees submit the NEW plan once every 3 years) = 14.
\2\ We estimate that 42 of the 78 NEW grantees will not include their NEW programs in Public Law 102-477
projects and therefore will submit the NEW program report to HHS.
Estimated Total Annual Burden Hours: 1036 \3\
---------------------------------------------------------------------------
\3\ Two additional programs joined the Public Law 102-477 since
the publication of FR1, hence the burden is different.
---------------------------------------------------------------------------
Authority: 42 U.S.C. 612.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-15909 Filed 7-25-19; 8:45 am]
BILLING CODE 4184-36-P
