Att 2_60day published FRN

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Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Number of
respondents

Type of respondents

Form name

Partner site staff ................................

CCL Partner Site-Level Interview
Guide.

45

Average
burden per
response

Total burden
(in hours)

1

1.5

22.5

1
1
1
1

2
2
2
2

33.5
17.5
16
33.5

40

1

2.5

67

40

1

2.5

67

40

1

2.5

67

25

1

2.5

21

50

1

2.5

42

Category B Case Study—SHD-Level Interview
HD
HD
HD
HD

recipient
recipient
recipient
recipient

staff
staff
staff
staff

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

CQM HD Recipient Interview Guide
TBC HD Recipient Interview Guide
MTM HD Recipient Interview Guide
CCL HD Recipient Interview Guide

25
13
12
25

Category B Case Study SHD-Level Group Discussion Guide
HD recipient staff ..............................
HD recipient staff ..............................
HD recipient staff ..............................

CQM HD Recipient Group Discussion Guide.
TBC HD Recipient Group Discussion Guide.
CCL HD Recipient Group Discussion Guide.
Category B Cost Study

HD recipient staff ..............................
Partner site staff ................................

HD Recipient Resource Use and
Cost Inventory Tool (Category B).
Partner Site-Level Resource Use
and Cost Inventory Tool (Category B).

Recipient-Led Evaluation Report Templates
HD recipient staff ..............................
HD recipient staff ..............................
HD recipient staff ..............................

Total ...........................................

Category A EPMP Template ............
Category A—DDT Recipient-led Annual Evaluation Report Template(s).
Category B—DHDSP Recipient-led
Evaluation Reporting Deliverable
Template(s).

51
51

1
1

8
8

136
408

51

1

8

408

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

1,792

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

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

2,303

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14301 Filed 7–3–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–19BHM; Docket No. CDC–2019–
0056]

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Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS)
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of

SUMMARY:

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its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Understanding
important issues in Ovarian Cancer
Survivorship (OCS) project. The OCS
project aims to better understand the
needs of ovarian cancer survivors and
how to more effectively develop
interventions targeted to this
population.
Written comments must be
received on or before September 3,
2019.

DATES:

You may submit comments,
identified by Docket No. CDC–2019–
0056 by any of the following methods:

ADDRESSES:

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• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: All public comment
should be submitted through the
Federal eRulemaking portal
(regulations.gov) or by U.S. Mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–

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32188

Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices

D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submissions of responses.
5. Assess information collection costs.
Proposed Project
Understanding the needs of Ovarian
Cancer Survivors—New—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),

2. What kinds of pharmacologic and
non-pharmacologic interventions do
ovarian cancer survivors utilize to
manage their conditions?
3. What barriers to ovarian cancer
survivors have in accessing and
receiving appropriate diagnostic care,
treatment, and follow-up care?
4. What unmet needs do ovarian
cancer survivors have?
The overall sample design targets
1,500 completed interviews. We assume
that approximately 80% of completed
surveys will come from more traditional
sampling utilizing lists from the state
cancer registries (n=1,200). The
remainder of the completed interviews
will come through social media
outreach and respondent-driven
sampling (RDS) methods (n=300). This
is a one year data collection period.
For the social media recruitment,
individuals will be recruited to
participate in the web survey through
advertisements posted on social media
sites. These ads are targeted toward the
specific population of women we wish
to complete the survey. Interested
respondents who click on an ad will be
routed to the survey landing page which
will explain the purpose of the study
and include consent language. If the
respondent is eligible, she will complete
the same survey as those recruited via
the state cancer registries.
Each recruitment method (registry
based or social media based) will have
an opportunity to recruit other women
into the study through respondentdriven sampling (RDS). We anticipate
that the majority of completed
interviews will be obtained through
traditional sampling practices, RDS
provides an efficient way to identify
other potentially eligible respondents
through a networked-based recruitment
approach.
Participation is voluntary. There are
no costs to respondents other than their
time. The total estimated annual burden
hours are 1,253.

Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Ovarian cancer is the ninth most
common cancer and the fifth leading
cause of cancer death among women in
the United States. Over 20,000 women
are diagnosed with ovarian cancer each
year. Due to the lack of a recommended
screening test, ovarian cancer is often
diagnosed at late stages, leading to low
five-year survival rates. While previous
studies are able to identify some of the
needs of ovarian cancer survivors,
particularly related to physical
complications and side effects,
additional research is needed to further
understand the experiences and needs
of survivors.
The National Academies of Sciences,
Engineering, and Medicine released
their report, Ovarian Cancers: Evolving
Paradigms in Research and Care, which
identified key priorities for researchers,
including recommending research on
the ‘‘supportive care needs of ovarian
cancer survivors throughout the disease
trajectory’’. In order to address these
research gaps and supplement current
knowledge of the ongoing needs of
survivors, including how to implement
programs and interventions to improve
their health, CDC has supported a
survey of ovarian cancer survivors.
The goal of this project is to better
understand the needs of ovarian cancer
survivors and how to more effectively
develop interventions targeted to this
population. To achieve this goal,
multiple recruitment methods will be
utilized to recruit this unique
population of women for the study. By
using state cancer registries, social
media advertisements, and respondentdriven sampling (RDS), the study will
ensure recruitment of a diverse
population of women.
This study will focus on the following
research questions:
1. What physical and mental
conditions do ovarian cancer survivors
experience?

ESTIMATED ANNUALIZED BURDEN HOURS

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Type of respondents
Ovarian cancer survivors—state
cancer registries.
Ovarian cancer survivors—social
media recruitment.
Ovarian cancer survivors—Respondent Driven Sampling.
Ovarian cancer survivors recruited
via social medial and RDS (ineligible).

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17:54 Jul 03, 2019

Number of
respondents

Form name
Mail in or web-based questionnaire

Number of
responses per
respondent

Avg. burden
per response
(in hours)

Total burden
(in hours)

1,200

1

50/60

1,000

Web-based questionnaire ................

195

1

50/60

163

Web-based questionnaire ................

105

1

50/60

88

Screener Only ..................................

100

1

2/60

3

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Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices

32189

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Total ...........................................

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14302 Filed 7–3–19; 8:45 am]

Number of
responses per
respondent

Avg. burden
per response
(in hours)

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

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

Number of
respondents

Form name

1,600

Dated: July 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14362 Filed 7–3–19; 8:45 am]
BILLING CODE 4164–01–P

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Health Resources and Services
Administration

Food and Drug Administration
[Docket No. FDA–2017–D–4303]

Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling; Draft Guidance for Industry;
Availability; Correction
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice; correction.

Lisa
Granger, Office of Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3330, Silver Spring,
MD 20993–0002, 301–796–9115.

FOR FURTHER INFORMATION CONTACT:

In the
Federal Register of Tuesday, September
5, 2017 (82 FR 41968), in FR Doc. 2017–
18506, the following correction is made:
On page 41968, in the first column, in
the header of the document, and in the
second column, under Instructions,
‘‘[Docket No. FDA–2017–E–4282]’’ is
corrected to read ‘‘[Docket No. FDA–
2017–D–4303].’’

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SUPPLEMENTARY INFORMATION:

17:54 Jul 03, 2019

Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces 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 seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than September 3,
2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Nurse Anesthetist Traineeship (NAT)
SUMMARY:

The Food and Drug
Administration is correcting a notice
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Content of the Risk Evaluation and
Mitigation Strategies Document Using
Structured Product Labeling; Draft
Guidance for Industry; Availability’’
that appeared in the Federal Register of
September 5, 2017. The document
announced the availability of a guidance
for industry. The document was
published with the incorrect docket
number. This document corrects that
error. Previously submitted comments
will be transferred to the correct docket
number.

SUMMARY:

VerDate Sep<11>2014

Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Nurse
Anesthetist Traineeship Program
Specific Data Forms, OMB No. 0915–
0374—Revision

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Total burden
(in hours)
1,253

Program Specific Data Forms
(Application), OMB Number 0915–
0374—Revision.
Abstract: HRSA provides advanced
education nursing training grants to
educational institutions to increase the
numbers of Nurse Anesthetists through
the NAT Program. NAT Program is
authorized by Section 811 of the Public
Health Service (PHS) Act (42 U.S.C.
296j). The NAT Tables request
information on program participants
such as the total number of enrollees,
number of enrollees/trainees supported,
total number of graduates, number of
graduates supported, projected data on
the number of enrollees/trainees, and
the distribution of Nurse Anesthetists
who practice in underserved, rural, or
public health practice settings.
Need and Proposed Use of the
Information: Funds appropriated for the
NAT Program are distributed among
eligible institutions based on a formula,
as permitted by PHS Act section
806(e)(1). HRSA uses the data from the
NAT Tables to: (1) Determine whether
funding preferences or special
considerations are met; (2) calculate
award amounts; ensure compliance with
programmatic and grant requirements;
and (3) provide information to the
public and Congress. NAT Tables
currently collect one year of data, which
allows HRSA to calculate award
amounts for a single-year project period.
For fiscal year 2020, HRSA is revising
the forms that previously collected one
year of data on prospective students to
capture three years of data, thereby
allowing HRSA to calculate award
amounts for a multi-year project period.
Table 1 will add an option to add year
2 and year 3 data for the number of
prospective students. Table 2 will not be
changed.
Likely Respondents: Respondents will
be applicants to HRSA’s NAT program.
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

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