Attachment B

Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
panelists and speakers (including a
moderator) per each of the 4 sessions
and will be open to the public.

Dated: May 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.

III. Purpose

[FR Doc. 2015–11536 Filed 5–12–15; 8:45 am]

The purpose of this 2-day workshop
is to provide an interdisciplinary forum
to discuss the best practices of dose
finding and dose selection for small
molecule kinase inhibitors developed
for oncology indications. The goal is to
foster robust scientific discussion to
promote a movement away from the
conventional 3+3 dose escalation trial
design and move toward adaptive
designs that can potentially incorporate
key clinical, pharmacologic, and
pharmacometric data and, when
appropriate, nonclinical information to
guide dose selection. Ideally, this
workshop will propel a movement
toward integrating dose finding into the
entire life cycle of product development
as opposed to confining it to the Phase
1, first-in-human trial based on shortterm safety measures.

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IV. Goals and Scope
1. To identify key best practices in the
nonclinical evaluation of a compound,
including, but not limited to, selectivity,
pharmacology, secondary
pharmacology, and toxicology.
2. To assess whether nonclinical
information can be incorporated into the
statistical assumptions of an adaptive
dose-finding trial.
3. To discuss the best practices of
integrating human pharmacokinetic and
pharmacometric data, including drug
interaction, when appropriate, into
dose-finding studies.
4. To assess how drug exposure can
be integrated into the statistical
assumptions of an adaptive dose-finding
trial and to assess whether evolving
exposure data can be adapted into an
ongoing trial.
5. To discuss barriers in moving away
from 3+3 designs toward adaptive
designs and to encourage creative dosefinding trial designs that can replace the
conventional 3+3 dose-finding study,
where appropriate.
6. To shift from conducting a large
single-arm drug trial with the maximum
tolerated dose based on a 28-day
window to identify tolerable,
biologically effective doses for
confirmatory trials through prudent
search of doses based on safety, efficacy,
and patient tolerability.
7. To discuss potential regulatory
implications of dose-finding studies,
including, but not limited to, product
labeling of dose ranges, dose titration,
and postmarketing studies.

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BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Administration for Children and
Families
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, Administration for
Children and Families, HHS.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) and the
Administration for Children and
Families (ACF) announce plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA and ACF seek comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than July 13, 2015.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Quarterly Data Request.
OMB No.: 0906-xxxx—New.
SUMMARY:

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Abstract: The Maternal, Infant, and
Early Childhood Home Visiting Program
(MIECHV), administered by HRSA in
close partnership with the
Administration for Children and
Families (ACF), supports voluntary,
evidence-based home visiting services
during pregnancy and to parents with
young children up to kindergarten
entry. States and tribal entities are
eligible to receive funding from the
MIECHV Program and have the
flexibility to tailor the program to serve
the specific needs of their communities.
Need and Proposed Use of the
Information: In order to continuously
monitor and provide oversight and
quality improvement guidance and
technical assistance to Home Visiting
Program grantees, HHS is seeking to
collect two categories of information:
Service Utilization Data and Corrective
Action Benchmark Data.
Service Utilization Data is made up of
four data categories:
(1) Program Capacity: HHS is seeking
to collect information related to the
overall home visiting service capacity in
number of families that grantees are able
to provide to the communities they
work in, the actual capacity being
utilized at certain points in time, as well
as updates of home visiting enrollment
in number of families.
(2) Place-Based Services: HHS is
seeking to collect information about the
geographic areas where home visiting
services are being provided.
Specifically, data on zip code and
locally defined communities are being
requested from Home Visiting Program
grantees in order to allow grantees an
opportunity to provide data about
geographic areas that are most salient to
their respective programs. Currently,
HHS has the authority to collect
information related to service area zip
code on an annual basis (OMB–0915–
0357, expiration 7/31/2017). HHS plans
to allow the grantee to describe the
service community at the neighborhood,
town, or city level where services are
provided based on their judgment of
local salience, rather than solely at the
county level, which is how geographic
services are currently reported.
(3) Family Engagement: Currently
HHS has the authority to collect
information related to family
engagement (attrition) on an annual
basis (OMB–0915–0357, expiration
7/31/2017). However, HHS has learned
through grants monitoring and technical
assistance efforts that family
engagement is an ongoing and complex
issue for home visiting service
providers. In order to monitor grantee
performance and target technical
assistance efforts most effectively, HHS

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Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices

is seeking to collect information on
family engagement on a more frequent
basis. HHS proposes that in addition to
annual reporting, Home Visiting
Program grantees will report quarterly
on the existing family engagement
metrics they are required to submit.
These metrics are currently defined as
the number of participants currently
receiving services who have completed
the program, who stopped services
before completion, and other
participants.
(4) Staff Recruitment and Retention:
HHS is seeking to collect information
related to the number of home visitors
and other support staff who are
currently employed directly or through
sub-contracted grant funds. Staff
recruitment and retention is a key
component to the successful delivery of
home visiting services and to
maximizing the number of cases each
local implementing agency can reach.
Home Visiting Program grantees will
report quarterly the actual number of
staff and current vacancies in three
categories: Home visitors, program
administration, and support staff.

Corrective Action Benchmark Data is
made up of one category of data:
Corrective Action Constructs. Home
Visiting Program grantees who have not
shown improvement in four of six
Benchmark areas after 3 years of grant
funding are statutorily required to
complete corrective action plans,
subject to approval by the Secretary, in
order to show how they plan to achieve
improvement in deficient areas.
Currently HHS collects information
related to selected Benchmark areas
from all Home Visiting Program grantees
on an annual basis (OMB–0915–0357,
expiration 7/31/2017). In order to
monitor grantee improvement toward
meeting these Benchmarks, HHS is
seeking to collect information from
grantees on implementation of their
corrective action plans on a more
frequent basis. HHS proposes that
grantees with corrective action plans
report on a quarterly basis for the
Benchmark measures for which they
were deemed as not showing
improvement. It is estimated that
approximately 15 grantees per year will
require this more frequent reporting.

This information will be used to
monitor and provide continued
oversight for grantee performance and to
target technical assistance resources to
grantees.
Likely Respondents: Home Visiting
Program grantees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Service Utilization Data:
Service Utilization Data—Formula Grants ....................
Service Utilization Data—Competitive Grants ..............
Service Utilization Data—Tribal Grants ........................
Corrective Action Benchmark Data:
Corrective Action Constructs—MIECHV Grants ..........
Corrective Action Constructs—Tribal Grants ...............
Total .......................................................................

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HHS specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.

Number of
responses per
respondent

4
4
4

224
176
100

24
24
24

5,376
4,224
2,400

10
5

4
4

40
20

40
40

1,600
800

140

........................

560

........................

14,400

Dated: May 1, 2015.
Jackie Painter,
Director, Division of the Executive Secretariat.
Linda K. Smith,
Deputy Assistant Secretary and InterDepartmental Liaison for Early Childhood
Development, Administration for Children
and Families.
[FR Doc. 2015–11547 Filed 5–12–15; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institute for
Occupational Safety and Health

AGENCY:

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Total burden
hours

56
44
25

Decision To Evaluate a Petition To
Designate a Class of Employees From
the Blockson Chemical Company in
Joliet, Illinois, To Be Included in the
Special Exposure Cohort

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(in hours)

Total
responses

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(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
ACTION: Notice.
NIOSH gives notice of a
decision to evaluate a petition to
designate a class of employees from the
Blockson Chemical Company in Joliet,
Illinois, to be included in the Special
Exposure Cohort under the Energy
Employees Occupational Illness
Compensation Program Act of 2000.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 1090 Tusculum
Avenue, MS C–46, Cincinnati, OH
45226–1938, Telephone 877–222–7570.
Information requests can also be
submitted by email to [email protected].
SUMMARY:

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