18848 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs) 

Total burden 

(in hrs) 

Local Health Department Representative.Interview Guide for Local Health Department Representative.15 1 30/60 8 

Older Adult—Screened Out .............. Senior Village Survey ....................... 1,431 1 1/60 24 

Older Adult—Participant ................... Senior Village Survey ....................... 1,550 1 20/60 517 

Total ........................................... ........................................................... ........................ ........................ ........................ 580 

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. 2015–08027 Filed 4–7–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces a meeting for the initial 

review of applications in response to 

(FOA) DP15–001, Natural Experiments 

of the Impact of Population-targeted 

Health Policies to Prevent Diabetes and 

its Complications. 

Time And Date: 11 a.m.–6 p.m., May 

5–6, 2015 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 552b(c) 

(4) and (6), Title 5 U.S.C., and the 

Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

Matters For Discussion: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘Natural Experiments of the Impact of 

Population-targeted Health Policies to 

Prevent Diabetes and its Complications, 

DP15–001, initial review.’’ 

Contact Person For More Information: 

Brenda Colley Gilbert, Ph.D., M.S.P.H., 

Director, Extramural Research Program 

Operations and Services, CDC, 4770 

Buford Highway NE., Mailstop F–80, 

Atlanta, Georgia 30341, Telephone: 

(770) 488–6295, BJC4@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Catherine Ramadei, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2015–07997 Filed 4–7–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–1005; Docket No. CDC–2015– 

0018] 

Proposed Data Collection 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 the information collection 

request for reinstatement with change of 

the collection previously approved 

under OMB control number 0920– 

1005—‘‘Conduct an Older Adult 

Mobility Assessment Tool Impact 

Evaluation and Develop a 

Dissemination Plan’’. This collection 

will help evaluate whether the Mobility 

Planning Tool is effective for promoting 

readiness to adopt mobility-protective 

behaviors in older adults. 

DATES: Written comments must be 

received on or before June 8, 2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2015– 

0018 by any of the following methods: 

Federal eRulemaking Portal: 

Regulation.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: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact the Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., MS–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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 18849 

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 

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 

Conduct an Older Adult Mobility 

Assessment Tool Impact Evaluation and 

Develop a Dissemination Plan (OMB 

Control No. 0920–1005)—Reinstatement 

with Change—National Center for Injury 

Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

CDC’s National Center for Injury 

Prevention and Control (NCIPC) 

requests approval for 3 years, from the 

Office of Management and Budget 

(OMB) for a reinstatement with change 

for the previously approved OMB No. 

0920–1005 (Exp. Date: 12–31–2014) 

designed to evaluate whether the 

Mobility Planning Tool is effective for 

promoting readiness to adopt mobilityprotective behaviors in older adults and 

assess potential strategies for 

dissemination of the Mobility Planning 

Tool. With this reinstatement, NCIPC 

requests a change of title from ‘‘Older 

Adult Safe Mobility Assessment Tool’’ 

to ‘‘Conduct an Older Adult Mobility 

Assessment Tool Impact Evaluation and 

Develop a Dissemination Plan.’’ 

The population of older adults in the 

U.S. is growing rapidly. By 2030, this 

segment of the population will increase 

to an estimated 72 million (20% of the 

U.S. population). A critical public 

health issue for the older adult 

population is mobility—how well 

people are able to get to places they 

need to go. The goals of this study are 

to evaluate (1) whether the Mobility 

Planning Tool (MPT) is effective for 

promoting readiness to adopt mobilityprotective behaviors in older adults and 

(2) assess potential strategies for 

dissemination of the MPT. 

NCIPC will collect study data using 

telephone interviews. The study 

population is community-living older 

adults ages 60–74 with no known 

mobility limitations. A total of 1,000 

individuals will participate in the study. 

Prospective respondents will answer a 

series of screening questions. 

Individuals who meet the screening 

criteria and are willing to participate 

will complete a baseline and follow-up 

interview each lasting approximately 10 

minutes. 

NCIPC will analyzed the collected 

data using descriptive statistics and a 

series of t-tests, chi-square analyses, and 

Mann-Whitney U-tests. Multivariate 

analyses will include a series of 

repeated measures Analysis of Variance 

(ANOVA), and logistic regressions. 

The data collected from this study 

will help CDC identify what further 

revisions to the MPT might be necessary 

before it is disseminated publicly. 

Selected study findings may eventually 

be presented in oral and poster 

presentations and published in a peerreviewed journal. Without this 

information collection, CDC will not 

know whether the MPT is an effective 

tool for promoting readiness to adopt 

mobility-protective behaviors in older 

adults and will not know whether 

additional revisions to the tool are 

necessary before the MPT is 

disseminated publicly. Without this 

study, CDC will have limited 

information about what strategies are 

most likely to be effective for 

disseminating the MPT publicly to the 

target audience. 

The total estimated annual burden 

hours are 734. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Individuals Responding to Initial 

Phone Call Who Refuse to be 

Screened.

Screening Interview Guide ............... 2,500 1 1/60 42 

Individuals Responding to Initial 

Phone Call Responding to Screening Questions.

Screening Interview Guide ............... 1,500 1 5/60 125 

Study Participants ............................. Baseline Interview Guide ................. 1,000 1 10/60 167 

Study Participants ............................. MPT .................................................. 500 1 30/60 250 

Study Participants ............................. Follow-up Interview Guide ............... 900 1 10/60 150 

Total ........................................... ........................................................... ........................ ........................ ........................ 734 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
18850 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / 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. 2015–08028 Filed 4–7–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0986] 

Center for Devices and Radiological 

Health: Experiential Learning Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Devices and Radiological Health (CDRH 

or Center) is announcing the 2015 

Experiential Learning Program (ELP). 

This training component is intended to 

provide CDRH staff with an opportunity 

to understand the policies, laboratory 

practices, and challenges faced in 

broader disciplines that impact the 

device development life cycle. The 

purpose of this document is to invite 

medical device industry, academia, and 

health care facilities to apply to 

participate in this formal training 

program for FDA’s medical device 

review staff, or to contact CDRH for 

more information regarding the ELP. 

DATES: Submit either an electronic or 

written request for participation in the 

ELP by May 8, 2015. The proposal 

should include a description of your 

facility relative to focus areas described 

in tables 1or 2). Please include the Area 

of Interest (see tables 1or 2) that the site 

visit will demonstrate to CDRH staff, a 

contact person, site visit location(s), 

length of site visit, proposed dates, and 

maximum number of CDRH staff that 

can be accommodated during a site 

visit. Proposals submitted without this 

minimum information will not be 

considered. In addition, please include 

an agenda outlining the proposed 

training for the site visit. A sample 

request and agenda are available on the 

ELP Web site at http://www.fda.gov/

downloads/ScienceResearch/

ScienceCareerOpportunities/

UCM392988.pdf and http://

www.fda.gov/scienceresearch/

sciencecareeropportunities/

ucm380676.htm. 

ADDRESSES: Submit either electronic 

requests to http://www.regulations.gov 

or written requests to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Identify proposals with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Latonya Powell, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5232, Silver Spring, 

MD 20993–0002, 301–796–6965, FAX: 

301–827–3079, Latonya.powell@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is responsible for ensuring the 

safety and effectiveness of medical 

devices marketed in the United States. 

Furthermore, CDRH assures that 

patients and providers have timely and 

continued access to high-quality, safe, 

and effective medical devices. In 

support of this mission, the Center 

launched various training and 

development initiatives to enhance 

performance of its staff involved in 

regulatory review and in the premarket 

review process. One of these initiatives, 

the ELP Pilot, was launched in 2012 and 

fully implemented on April 2, 2013 (78 

FR 19711). CDRH is committed to 

advancing regulatory science; providing 

industry with predictable, consistent, 

transparent, and efficient regulatory 

pathways; and helping to ensure 

consumer confidence in medical 

devices marketed in the United States 

and throughout the world. The ELP is 

intended to provide CDRH staff with an 

opportunity to understand the policies, 

laboratory practices, and challenges 

faced in broader disciplines that impact 

the device development life cycle. This 

is a collaborative effort to enhance 

communication and facilitate the 

premarket review process. Furthermore, 

CDRH is committed to understanding 

current industry practices, innovative 

technologies, regulatory impacts, and 

regulatory needs. 

These formal training visits are not 

intended for FDA to inspect, assess, 

judge, or perform a regulatory function 

(e.g., compliance inspection), but rather, 

they are an opportunity to provide 

CDRH review staff a better 

understanding of the products they 

review. Through this notice, CDRH is 

formally requesting participation from 

companies, academia, and clinical 

facilities, including those that have 

previously participated in the ELP or 

other FDA site visit programs. 

II. ELP 

A. ELP Training Component 

In this training program, groups of 

CDRH staff will observe operations at 

research, manufacturing, academia, and 

health care facilities. The focus areas 

and specific areas of interest for visits 

may include the following: 

TABLE 1—AREAS OF INTEREST—MEDICAL DEVICES/TECHNOLOGY

Focus area Specific areas of interest 

Failure analysis of orthopedic devices.Methods for retrieval and preservation of failed implants for analysis; understanding how retrieved implants 

may be analyzed; methods for identifying failure modes; understanding how analysis of failed implants 

influences device design modifications. 

Radiologic analysis of orthopedic 

devices.

Methods of radiologic analysis and associated data analyses; radiologic imaging core laboratories. 

Automated external defibrillators 

(AEDs).

Manufacturing process; incoming component inspection; design verification testing; human factors testing; 

returned product testing (as available). 

Diagnostic imaging catheters for 

cardiovascular diseases.

Manufacturing process; design verification testing; returned product testing (as available); ultrasound, optical coherence tomography (OCT), and near infrared spectroscopy (NIS) catheters. 

Endovascular grafts for treatment of 

aortic aneurysms.

Physician-sponsored clinical studies; observation of endovascular grafting surgical procedure; surgical 

planning process; factors that influence device modifications (e.g., patient anatomy, patient pathology). 

Animal models for evaluation of hemostatic devices.Models of traumatic injury and severe hemorrhage; limitations of the model; understanding the relevance 

of the data generated from these models in evaluating hemostatic devices. 

Hyaluronic acid in dermal tissue 

fillers.

Manufacturing process; source materials; performance testing (e.g., material characterization, biocompatibility, residence time). 

Minimally invasive glaucoma surgery (MIGS) devices.Observation of a MIGS procedure; surgical planning; surgical challenges. 


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