Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69863 

that facility’s healthcare system. 

Are these factors appropriate and/or 

sufficient to both mitigate risks and 

to provide patient access if 

warranted? Should FDA use 

different factors to best balance 

patient safety and patient access? 

• For the categories of Traditional 

LDTs and LDTs for Unmet Needs, 

one of the factors for enforcement 

discretion is whether the LDT is 

both manufactured and used by a 

healthcare facility laboratory (such 

as one located in a hospital or 

clinic) for a patient that is being 

diagnosed and/or treated at that 

same healthcare facility, or within 

the facility’s healthcare system. To 

further clarify this factor, the 

Framework draft guidance 

document explains that ‘‘healthcare 

system’’ refers to a collection of 

hospitals that are owned and 

operated by the same entity and 

that share access to patient care 

information for their patients, such 

as, but not limited to, drug order 

information, treatment and 

diagnosis information, and patient 

outcomes. If this is an appropriate 

factor to use, are the considerations 

about which types of facilities 

would or would not be included 

within a healthcare system as 

defined by the draft guidance 

appropriate? Is there an alternative 

definition of healthcare system that 

would be more appropriate? 

• Do the FDA-proposed categories for 

continued enforcement discretion 

appropriately encompass the LDTs 

that should remain under 

enforcement discretion? Should the 

scope of proposed categories be 

broadened or narrowed? If so, how? 

Should additional categories for 

continued enforcement discretion 

be added or proposed categories 

removed? If so, which categories? 

For any new proposed categories, 

what are the appropriate factors in 

considering enforcement 

discretion? 

• Is the information provided detailed 

enough for laboratories to make a 

determination that their LDT falls 

within one of these categories of 

continued enforcement discretion? 

Session 4: Notification and Adverse 

Event Reporting (MDRs) 

• Will notification be adequate to 

provide FDA, laboratories, 

providers, patients, and other 

members of the public a 

comprehensive list of what tests are 

currently available for a specific 

intended use? 

• Would it be sufficient to allow 

laboratory networks (i.e., more than 

one laboratory under the control of 

the same parent entity) that offer 

the same test in multiple 

laboratories throughout their 

network to submit a single 

notification for that test? 

• Are there certain types of LDTs for 

which the Agency should neither 

enforce requirements for 

registration and listing nor request 

notification in lieu of registration 

and listing? 

• How can FDA leverage other 

information in the community to 

reduce the information collection 

associated with notification for 

laboratories while still obtaining 

sufficient information to inform the 

LDT classification and 

prioritization process? 

Session 5: Public Process for 

Classification and Prioritization 

• How should FDA structure the 

advisory panels that will be 

convened to provide input to help 

FDA classify LDTs and prioritize 

them for enforcement of FDA 

premarket review requirements? 

• Which stakeholders should be able 

to present relevant information or 

views at the panel meetings to 

discuss the classification and 

prioritization of LDTs? 

• What factors should be considered 

in determining LDT classification 

and risk? 

• How should the advisory panel 

process weigh these factors when 

providing input for classifying 

LDTs and prioritizing LDTs for 

enforcement of FDA premarket 

review requirements? 

Session 6: Quality System Regulation 

• How can laboratories best leverage 

their current processes and 

procedures, implemented to meet 

CLIA accreditation requirements, to 

meet the FDA QS regulation 

requirements in the least 

burdensome manner? 

• Are there FDA QS requirements 

that differ from CLIA requirements 

that FDA should continue not to 

enforce for laboratories that make 

LDTs? 

• What additional resources will 

laboratories need in order to assist 

them with implementation of the 

QS regulation? 

• What is the appropriate timeframe 

for phase-in enforcement of QS 

regulation requirements in general 

and for design controls specifically? 

Dated: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27713 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1818] 

New Clinical Trials Demographic Data; 

Availability for Comment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability for public comment of 

Demographic Subgroup Data for FDA 

Approved Products on FDA’s Internet 

Web site. This new posting implements 

Action 3.1 from Priority 3 of the Food 

and Drug Administration Safety and 

Innovation Act (FDASIA) Section 907 

Action Plan designed to improve the 

availability and transparency of clinical 

trial demographic subgroup data. FDA is 

requesting comments on the format, 

content, and overall usability of the site 

to determine whether this approach is 

user friendly to the public. 

DATES: Submit electronic or written 

comments on the content by January 23, 

2015. 

ADDRESSES: Submit electronic 

comments on the Web page to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Laurie Haughey, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–6511, 

Laurie.Haughey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

clinical trial demographic data for 

consumers on FDA’s Internet Web site 

at www.fda.gov/drugtrialssnapshot. 

On July 9, 2012, the President signed 

FDASIA (Pub. L. 112–144) into law. 

Section 907 of FDASIA requires that 

FDA report on and address certain 

information regarding clinical trial 

participation by demographic subgroups 

and subset analysis of the resulting data. 

Specifically, section 907(a) of FDASIA 

requires the Secretary of Health and 

Human Services (the Secretary), acting 

through the FDA Commissioner, to 

publish on FDA’s Internet Web site a 

report ‘‘addressing the extent to which 

clinical trial participation and the 

inclusion of safety and effectiveness 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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