Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices 5127 

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

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hrs.) 

Women with SLE diagnosis .... Screener for Women .............................................................. 192 1 10/60 

Prototype CDC SLE Self-management Tool ......................... 128 1 2 

Discussion Guide for Use in Focus Groups with Women or 

Interviews with Men.

128 1 2 

Men with SLE diagnosis ......... Screener for Men ................................................................... 40 1 10/60 

Prototype CDC SLE Self-management Tool ......................... 20 2 2 

Discussion Guide for Use in Focus Groups with Women or 

Interviews with Men.

20 1 45/60 

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 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: 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 

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. 

DATES: Written comments must be 

received on or before April 1, 2016. 

ADDRESSES: 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. 

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 


rmajette on DSK2TPTVN1PROD with NOTICES
5128 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) 

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 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Health Professionals ......................... Training and Continuing Education 

Online New Participant Registration Form.

200,000 1 5/60 16,667 

Health Educators ............................... Training and Continuing Education 

Online.

120 1 5 600 

Total ........................................... .......................................................... ........................ ........................ ........................ 17,267 


rmajette on DSK2TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices 5129 

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. 

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 

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 

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 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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 


rmajette on DSK2TPTVN1PROD with NOTICES