69864 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

data by demographic subgroups 

including sex, age, race, and ethnicity, 

is included in applications submitted to 

the FDA,’’ and provide such publication 

to Congress. The report, entitled 

‘‘Reporting of Inclusion of Demographic 

Subgroups in Clinical Trials and Data 

Analysis in Applications for Drugs, 

Biologics, and Devices,’’ was posted on 

FDA’s Internet Web site in August 2013 

and is available at http://www.fda.gov/

RegulatoryInformation/Legislation/

FederalFoodDrugandCosmeticActFDC

Act/SignificantAmendmentstotheFDC

Act/FDASIA/ucm356316.htm. 

Section 907(b) of FDASIA further 

requires the Secretary, again acting 

through the Commissioner, to publish 

an action plan on FDA’s Internet Web 

site and provide such publication to 

Congress. The action plan is to contain 

recommendations, as appropriate, to 

improve the completeness and quality 

of analyses of data on demographic 

subgroups in summaries of product 

safety and effectiveness and in labeling; 

on the inclusion of such data, or the 

lack of availability of such data in 

labeling; and on ways to improve public 

availability of such data to patients, 

health care providers, and researchers. 

These recommendations are to include, 

as appropriate, a determination that 

distinguishes between product types 

and applicability. The action plan is due 

not later than 1 year after the 

publication of the report described 

previously. The action plan entitled 

‘‘FDA Action Plan to Enhance the 

Collection and Availability of 

Demographic Subgroup Data’’ was 

published in August 2014 and is 

available at http://www.fda.gov/

RegulatoryInformation/Legislation/

FederalFoodDrugandCosmeticActFDC

Act/SignificantAmendmentstotheFDC

Act/FDASIA/ucm356316.htm. 

Priority three of the action plan aims 

to make demographic data more 

available and transparent by, amongst 

other things, posting demographic 

composition and analysis by subgroup 

in pivotal clinical studies for FDAapproved medical products. The first 

iteration of FDA’s publication of this 

data is available at www.fda.gov/

drugtrialssnapshot. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 19, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27732 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Assessing an Online Process 

To Study the Prevalence of Drugged 

Driving in the U.S.: Development of the 

Drugged Driving Reporting System 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute on Drug Abuse 

(NIDA), the National Institutes of Health 

(NIH) will publish periodic summaries 

of proposed projects to be submitted to 

the Office of Management and Budget 

(OMB) for review and approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) 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) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To Submit Comments and for Further 

Information: To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Harold 

Perl, Ph.D., Chief, Prevention Research 

Branch, Division of Epidemiology, 

Services & Prevention Research, NIDA, 

6001 Executive Blvd., Rockville, MD 

20852 or call this non-toll-free number 

(301) 443–6504, or email your request, 

including your address to: hperl@

nida.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Proposed Collection: Assessing an 

Online Process to Study the Prevalence 

of Drugged Driving in the U.S: 

Development of the Drugged Driving 

Reporting System. Type of Information 

Collection Request: 0925–NEW. 

National Institute on Drug Abuse 

(NIDA), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: The study seeks to provide 

an improved understanding of the 

prevalence of drugged driving among 

adult drivers in the U.S and will assess 

the effectiveness of the online survey 

implementation process. The primary 

objectives of the study are to: (a) To 

provide comprehensive data on drugged 

driving; (b) determine if the Drugged 

Driving Survey Instrument (DDS) is an 

effective and accurate measure of 

drugged driving among licensed U.S. 

Drivers aged 18 and older; and, (c) to 

assess the effectiveness of the survey 

implementation process, including 

various levels of incentives for 

participation to determine the 

appropriate/optimal incentive amount 

needed to obtain the desired number of 

total survey respondents within the 

timeframe within which survey data 

will be collected. The findings will 

provide valuable information 

concerning various aspects of substance 

use and driving behavior, including: (1) 

Demographic information about drivers 

who do and do not drive while impaired 

by medication and/or drugs (e.g. age, zip 

code, type of driver’s license); (2) which 

drugs/medications are most likely to be 

used while driving; (3) drivers’ beliefs 

and attitudes toward drugged driving. 

OMB approval is requested for 2 years. 

There are no direct costs to respondents 

other than their time. The total 

annualized estimated burden hours are 

750. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69865 

Study material Type of 

respondent 

Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

hour burden 

Drugged Driving Survey .................... Drivers (18 years of age or older) ... 3,750 1 12/60 750 

Dated: November 18, 2014. 

Genevieve deAlmeida, 

Project Clearance Liaison, National Institute 

on Drug Abuse. 

[FR Doc. 2014–27760 Filed 11–21–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request Electronic Prior Approval 

Submission System (ePASS) (NHLBI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung and Blood 

Institute (NHLBI), National Institutes of 

Health (NIH), will publish periodic 

summaries of proposed projects to be 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) 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) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To Submit Comments and for Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Ms. Suzanne White, 

6701 Rockledge, Office of Grants 

Management, National Heart, Lung, and 

Blood Institute, National Institutes of 

Health, 6701 Rockledge Dr., MSC 7926, 

Bethesda, MD 20892–7926, or call nontoll-free number 301–435–0166, or 

Email your request, including your 

address to whitesa@nhlbi.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Electronic Prior 

Approval Submission System (ePASS), 

0925—New, National Heart, Lung, and 

Blood Institute (NHLBI), National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: The purpose and use of the 

information collection for this project is 

to collect and track certain requests 

(such as budget modifications or 

undertaking particular activities) from 

NIH grantees in an electronic format. 

This new electronic system, ePASS 

(electronic Prior Approval Submission 

System), will enable grantees to have a 

standard way to submit requests for 

their projects per NIH policy. The 

grantee will initiate a request for a 

certain action as required by NIH policy: 

Use of unobligated balances/carryover, 

change of PI, change of effort, Training 

Grant (NRSA) waivers, significant 

rebudgeting, 2nd and 3rd no cost 

extensions, and change of scope. These 

are all prior approvals as required by the 

NIH Grants Policy, and need to be 

reviewed and approved by the NHLBI. 

ePASS will provide a template to ensure 

that all specific points are addressed 

and documented in the official grant 

file. All information is submitted via the 

internet, tracked in ePASS, and the 

documentation will automatically be 

forwarded to the official grant file. The 

system will ensure that individuals 

authorized by the grantee are submitting 

requests and that the appropriate NIH 

staff is receiving the requests. The 

requests will be template driven so that 

the grantee is including the minimally 

required information, thus eliminating 

the usual back and forth to obtain 

missing information. Forms will have 

automatic fill-in capability that will 

reduce typos in grant numbers and PI 

names, further reducing approval time. 

Reminders will be sent to NIH staff 

within ePASS based on roles to ensure 

timely responses to the grantee. The 

system will facilitate email 

communication with applicants by 

automatic notifications when 

applications are received and when NIH 

has made a determination regarding a 

request (approval issued or request 

denied with explanation for denial). 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

470. 

A.12–1—ESTIMATES OF HOUR BURDEN

Type of respondents Number of 

respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

NHLBI Grantees .............................................................................................. 940 1 30/60 470 

Dated: November 12, 2014. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2014–27762 Filed 11–21–14; 8:45 am] 

BILLING CODE 4140–01–P 


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