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consider making it available as a printed
resource, depending on the feedback
obtained during the testing process.
The information collection will also
gauge the needs of the target
audience(s), tool format and delivery
method(s), and the tool’s clarity,
relevance, salience and appeal. A series
of focus groups with women with a
diagnosis of SLE, and one-on-one
telephone interviews with men with a

diagnosis of SLE will be conducted to
assess the tool. The same discussion
guide will be used for all information
collections.
The estimated burden per response
for participating in a focus group
discussion is two hours. The estimated
burden per response for a discussion
conducted via telephone interview is 45
minutes. Respondent burden also
includes two hours for reviewing the

prototype CDC SLE Self-management
Tool in advance of the focus group
meeting or telephone interview.
OMB approval is requested for one
year. Participation is voluntary and
there are no costs to respondents other
than their time.
The total estimated burden hours are
646.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Women with SLE diagnosis ....

Screener for Women ..............................................................
Prototype CDC SLE Self-management Tool .........................
Discussion Guide for Use in Focus Groups with Women or
Interviews with Men.
Screener for Men ...................................................................
Prototype CDC SLE Self-management Tool .........................
Discussion Guide for Use in Focus Groups with Women or
Interviews with Men.

Men with SLE diagnosis .........

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–01720 Filed 1–29–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–16–0017; Docket No. CDC–2016–
0014]

Proposed Data Collections 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
its continuing efforts 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 proposed revisions of the
information collection entitled
Application for Training (OMB Control
No. 0920–0017). CDC seeks to request

SUMMARY:

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Number of
respondents

Type of respondents

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Office of Management and Budget
approval to (1) continue to collect
information through the use of the
Training and Continuing Education
Online New Participant Registration
form for new learners to establish an
account that provides CDC necessary
information to process learner requests
for continuing education, and (2)
implement a new electronic information
collection through the use of the
Training and Continuing Education
Online Proposal form that allows
training developers to provide CDC
necessary information to process and
accredit trainings for continuing
education.
Written comments must be
received on or before April 1, 2016.

DATES:

You may submit comments,
identified by Docket No. CDC–2016–
0014 by any of the following methods:
Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
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. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.

ADDRESSES:

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Number of
responses
per
respondent

Average
burden per
response
(in hrs.)

192
128
128

1
1
1

10/60
2
2

40
20
20

1
2
1

10/60
2
45/60

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:

Leroy A. Richardson, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570.
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.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the

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Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices

burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. 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.
Proposed Project
Application for Training (OMB
Control No. 0920–0017, Expiration 05/
31/2016)—Revision—Division of
Scientific Education and Professional
Development (DSEPD), Center for
Surveillance, Epidemiology and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC offers public health training to
professionals worldwide. Employees of
hospitals, universities, medical centers,
state and local health departments, and
federal agencies apply for training to
learn up-to-date public health and
healthcare practices. CDC is accredited
by multiple accreditation organizations
to award continuing education (CE) for
public health and healthcare
professions.
CDC requires health professionals
seeking continuing education (learners)

transcript or for determining whether a
person is enrolled in more than one
course. CDC uses the email address to
verify the participant’s electronic
request for transcripts, verify course
certificates, and send confirmation that
a participant is registered for a course.
Collection of demographic and
profession-specific data through the
TCEO New Participant Registration
allows CDC to comply with
accreditation organization requirements.
The TCEO Proposal will expedite
submission, review, and accreditation
processes and provide CDC with the
information necessary to meet
accreditation organization requirements,
accredit, and effectively manage training
activities. Examples of data to be
collected for CDC to process continuing
education proposals and meet
accreditation organization requirements
includes name, email address, phone
number, and organization name.
These forms do not duplicate request
for information from participants or
course developers. Data are collected
only once per new registration or once
per course.
These information collection
instruments have provided, and will
continue to provide CDC with the
information necessary to manage and
conduct training activities pertinent to
its mission to strengthen the skills of the
current workforce through quality,
accredited, competency-based training.
The annual burden table has been
updated to reflect (1) discontinuance of
the National Laboratory Training
Network Registration form, (2) an
increase in learners seeking continuing
education, particularly through elearning activities (16,667 burden
hours), (3) the introduction of the new
TCEO Proposal (600 burden hours), for
a total of 17,267 burden hours. There are
no costs to respondents.

to use the Training and Continuing
Education Online (TCEO) system to
establish an account by completing the
TCEO New Participant Registration
form. CDC/CSELS relies on this form to
collect information needed to
coordinate learner registration for
training activities including classroom
study, conferences, and e-learning.
The TCEO Proposal is a form course
developers will use the TCEO system to
apply for their training activities to
receive continuing education
accreditation through CDC. Introduction
of this mechanism will allow course
developers to electronically complete
and submit continuing education
proposals.
CDC requests OMB approval to (1)
continue to collect information through
the TCEO New Participant Registration
form to grant public health professionals
the continuing education they need to
maintain professional licenses and
certifications, create a transcript or
summary of training at the participant’s
request, generate management reports,
and maintain training statistics; and (2)
establish a new electronic information
collection that allows CDC or CDC
partner course developers to
electronically submit training and
continuing education proposals for
accreditation.
CDC’s TCEO system provides an
efficient and effective way for CDC to
comply with accreditation organization
requirements. Accreditation
organizations require a method of
tracking participants who complete an
education activity and several require
collection of profession-specific data.
Some accrediting organizations require
a permanent record that includes the
participant’s name, address, and phone
number to facilitate retrieval of
historical information about when a
participant completed a course or
several courses during a time period.
These data provide the basis for a

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Health Professionals .........................

Training and Continuing Education
Online New Participant Registration Form.
Training and Continuing Education
Online.

200,000

1

5/60

16,667

120

1

5

600

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

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

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

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

17,267

Health Educators ...............................
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Number of
respondents

Type of respondent

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

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Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–01722 Filed 1–29–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]

Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:

Food and Drug Administration,

HHS.

rmajette on DSK2TPTVN1PROD with NOTICES

ACTION:

Notice.

This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee:
Psychopharmacologic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 29, 2016, from 8 a.m. to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: http://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, PDAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at http://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the

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appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
the specific risk-benefit profile for new
drug application (NDA) 207318,
NUPLAZID (pimavanserin) 17 milligram
(mg) immediate-release, film-coated oral
tablets, submitted by Acadia
Pharmaceuticals Inc., for the proposed
treatment of psychosis associated with
Parkinson’s disease.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at http://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 15, 2016.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before March 7,
2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 8, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Kalyani Bhatt

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5129

at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
http://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: January 27, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–01752 Filed 1–29–16; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–XXXX–
60D]

Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit a new Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before April 1, 2016.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0990–
XXXX–60D for reference.
Information Collection Request Title:
Surgeon General’s Pledge to Stem the
Opioid Epidemic
Abstract: The Office of the Surgeon
General, Office of the Secretary,
Department of Health and Human
SUMMARY:

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