69860 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

compound human drugs called 

‘‘outsourcing facilities.’’ Section 

503B(d)(4) of the FD&C Act (21 U.S.C. 

353B(d)(4)) defines an outsourcing 

facility, in part, as a facility that 

complies with all of the requirements of 

section 503B, including registering with 

FDA as an outsourcing facility and 

paying associated fees. If the conditions 

outlined in section 503B(a) of the FD&C 

Act are satisfied, a drug compounded by 

or under the direct supervision of a 

licensed pharmacist in an outsourcing 

facility is exempt from certain sections 

of the FD&C Act, including section 

502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use) and section 

505 (21 U.S.C. 355) (concerning the 

approval of human drug products under 

new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). Drugs compounded in 

outsourcing facilities are not exempt 

from the requirements of section 

501(a)(2)(B) of the FD&C Act (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice for drugs). This 

guidance is intended to assist 

compounding facilities that wish to 

register as outsourcing facilities to 

register with FDA and discusses the 

process for registering, re-registering, 

and de-registering. 

In the Federal Register of December 4, 

2013 (78 FR 72899), FDA issued a notice 

announcing the availability of the draft 

version of this guidance. That draft 

guidance set forth an interim and 

electronic submission method for 

human drug compounders that elect to 

register as outsourcing facilities. The 

comment period on the draft guidance 

ended on February 3, 2014. FDA 

received nine comments on the draft 

guidance. Some of the received 

comments raised issues that were not 

directly pertinent to the topics 

addressed in this guidance. FDA intends 

to consider those comments as they 

relate to issues being addressed in other 

policy documents being developed by 

the Agency. 

In response to received comments or 

on its own initiative, FDA made the 

following changes as it finalized this 

guidance: (1) We included a phone 

number for a point of contact; (2) we 

deleted reference to an alternative 

interim registration method; (3) we 

added information on how a registered 

outsourcing facility can de-register; (4) 

we clarified what registration 

information will be made public; (5) we 

clarified the standard to be used to grant 

a waiver of the electronic submission 

requirements; and (6) we made 

grammatical and other minor editorial 

changes to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act 

This guidance contains collections of 

information that are subject to review by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3520). The 

collections of information have been 

approved under OMB control number 

0910–0777. 

III. Comments 

Interested persons can 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 can 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. 

IV. 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 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27693 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–D–0360 and FDA– 

2011–D–0357] 

Framework for Regulatory Oversight of 

Laboratory Developed Tests; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing the following 

public workshop entitled ‘‘Framework 

for Regulatory Oversight of Laboratory 

Developed Tests (LDTs).’’ The purpose 

of this workshop is to discuss FDA’s 

proposal for a risk-based framework for 

addressing the regulatory oversight of a 

subset of in vitro diagnostic devices 

(IVDs) referred to as laboratory 

developed tests (LDTs), which are 

intended for clinical use and designed, 

manufactured and used within a single 

laboratory, and provide an additional 

opportunity for public comment 

Dates and Times: The 2-day public 

workshop will be held on January 8, 

2015, from 8:30 a.m. to 5:30 p.m. and on 

January 9, 2015 from 8:30 a.m. to 5:30 

p.m. 

Location: The public workshop will 

be held at the Natcher Center at the 

National Institutes of Health Campus, 

9000 Rockville Pike, Bldg. 45, 

Auditorium, Bethesda, MD 20814. For 

parking and security information, please 

refer to http://www.nih.gov/about/

visitor/. 

Contact Person: Allen Webb, Center 

for Devices and Radiological Health, 

Food and Drug Administration, Bldg. 

66, Rm 5675, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 240– 

402–4217, LDTframework@fda.hhs.gov. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in attending 

this public workshop must register 

online by December 12, 2014, at 4 p.m. 

Early registration is recommended 

because facilities are limited and, 

therefore, FDA may limit the number of 

participants from each organization. If 

time and space permits, onsite 

registration on the day of the public 

workshop will be provided beginning at 

8 a.m. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan, (email: Susan.Monahan@

fda.hhs.gov or phone: 301–796–5661) no 

later than December 19, 2014. 

To register for the public workshop, 

please visit FDA’s Medical Devices 

News & Events—Workshops & 

Conferences calendar at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this meeting/public 

workshop from the posted events list.) 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, email, and 

telephone number. If you are unable to 

register online, please contact Susan 

Monahan (see Registration.) Registrants 

will receive confirmation after they have 

been accepted and will be notified if 

they are on a waiting list. 


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Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69861 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be Webcast. Persons interested in 

viewing the Webcast must register 

online. Early registration is 

recommended because Webcast 

connections are limited. Organizations 

are requested to register all participants, 

but to view using one connection per 

location. Webcast participants will be 

sent technical system requirements and 

connection access information after 

registration and prior to the meeting. If 

you have never attended a Connect Pro 

event before, test your connection at 

https://collaboration.fda.gov/common/

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit http://www.adobe.com/

go/connectpro_overview. (FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) The Webcast will 

be recorded and posted on FDA’s Web 

site after the meeting. 

Requests for Oral Presentations: This 

public workshop includes topic-focused 

public comment sessions. During online 

registration you may indicate if you 

wish to present during a public 

comment session, and which topics you 

wish to address. FDA has included 

general topics in this document. FDA 

will do its best to accommodate requests 

to make public comment. Individuals 

and organizations with common 

interests are urged to consolidate or 

coordinate their presentations, and 

request time for a joint presentation, or 

submit requests for designated 

representatives to participate in the 

focused sessions. Following the close of 

registration, FDA will determine the 

amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

December 17, 2014. All requests to make 

oral presentations must be received by 

the close of registration on December 12, 

2014. If selected for presentation, any 

presentation materials must be emailed 

to Allen Webb (see Contact Person) no 

later than January 6, 2015. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Comments: In order to permit the 

widest possible opportunity to obtain 

public comment, FDA is soliciting 

either electronic or written comments 

on all aspects of the public workshop 

topics. The deadline for submitting 

comments related to this public 

workshop is February 2, 2015. 

Regardless of attendance at the public 

workshop, interested persons may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 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. In addition, 

when responding to specific questions 

as outlined in section II of this 

document, please identify the question 

you are addressing. 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. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. A link to the 

transcripts will also be available 

approximately 45 days after the public 

workshop on the Internet at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this public 

workshop from the posted events list). 

SUPPLEMENTARY INFORMATION: 

I. Background 

In 1976, Congress enacted the Medical 

Device Amendments (MDA), which 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to create 

a comprehensive system for the 

regulation of medical devices intended 

for use in humans. At that time, the 

definition of a device was amended to 

make explicit that it encompassed in 

vitro diagnostic devices (IVDs): ‘‘The 

term ‘device’. . .means an instrument, 

apparatus, implement, machine, 

contrivance, implant, in vitro reagent, or 

other similar or related article. . . .’’ 

(section 201(h) of the FD&C Act (21 

U.S.C. 321(h)). The definition of device 

applies equally to IVDs manufactured 

by conventional device manufacturers 

and those manufactured by laboratories. 

An IVD, therefore, meets the device 

definition irrespective of where and by 

whom it is manufactured. 

Since the implementation of the MDA 

of 1976, FDA has exercised enforcement 

discretion so that the Agency has 

generally not enforced applicable 

provisions under the FD&C Act and 

FDA regulations with respect to LDTs, 

a subset of IVDs that are intended for 

clinical use and designed, 

manufactured, and used within a single 

laboratory. 

In 1976, LDTs were mostly 

manufactured in small volumes by local 

laboratories. Many laboratories 

manufactured LDTs that were similar to 

well-characterized, standard diagnostic 

devices, as well as other LDTs that were 

intended for use in diagnosing rare 

diseases or for other uses to meet the 

needs of a local patient population. 

LDTs at the time tended to rely on the 

manual techniques used by laboratory 

personnel. LDTs were typically used 

and interpreted directly by physicians 

and pathologists working within a 

single institution that was responsible 

for the patient. In addition, historically, 

LDTs were manufactured using 

components that were legally marketed 

for clinical use (i.e., general purpose 

reagents, immunohistochemical stains, 

and other components marketed in 

compliance with FDA regulatory 

requirements). 

Although some laboratories today still 

manufacture LDTs in this ‘‘traditional’’ 

manner, the landscape for laboratory 

testing in general, and LDTs along with 

it, has changed dramatically since 1976. 

Today, LDTs are often used in 

laboratories that are independent of the 

healthcare delivery entity. Additionally, 

LDTs are frequently manufactured with 

components and instruments that are 

not legally marketed for clinical use and 

also rely more heavily on complex, 

high-tech instrumentation and software 

to generate results and clinical 

interpretations. Moreover, technological 

advances have increased the use of 

diagnostic devices in guiding critical 

clinical management decisions for highrisk diseases and conditions, 

particularly in the context of 

personalized medicine. 

Business models for laboratories have 

also changed since 1976. With the 

advent of overnight shipping and 

electronic delivery of information (e.g., 

device results), a single laboratory can 

now easily provide device results 

nationally and internationally. Today, 

many new LDT manufacturers are large 

corporations that nationally market a 

limited number of complex, high-risk 

devices, in contrast to 1976 when 

hospital or public health laboratories 

used a wide range of devices that were 

generally either well characterized and 

similar to standard devices; used to 

diagnose rare diseases; or designed 

specifically to meet the needs of their 

local patients. Together, these changes 


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69862 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

have resulted in a significant shift in the 

types of LDTs developed, the business 

model for developing them, and the 

potential risks they pose to patients. 

Because of changes in the complexity 

and use of LDTs and the associated 

increased risks, as described earlier, 

FDA believes the policy of general 

enforcement discretion towards LDTs is 

no longer appropriate. To initiate this 

step toward greater oversight, FDA held 

a 2-day public meeting on July 19 and 

20, 2010, to provide a forum for 

stakeholders to discuss issues and 

concerns surrounding greater oversight 

of LDTs. Comments submitted to the 

public docket for the July 19 and 20, 

2010, public meeting were reviewed 

and, as appropriate, incorporated into 

FDA’s current proposed framework for 

regulatory oversight of LDTs. FDA’s July 

31, 2014, Notification to Congress 

concerning the Agency’s intent to issue 

the draft guidance, ‘‘Framework for 

Regulatory Oversight of Laboratory 

Developed Tests (LDTs)’’ (Framework 

draft guidance document), and the 

accompanying draft guidance, ‘‘FDA 

Notification and Medical Device 

Reporting for Laboratory Developed 

Tests (LDTs),’’ was made publicly 

available, and these draft guidance 

documents were subsequently issued on 

October 3, 2014. See 79 FR 59776 and 

79 FR 59779 (October 3, 2014). These 

documents describe a risk-based 

framework for addressing the regulatory 

oversight of LDTs, including FDA’s 

priorities for enforcing premarket and 

postmarket requirements for LDTs as 

well as the process by which FDA 

intends to phase in enforcement of FDA 

regulatory requirements for LDTs over 

time. As outlined in the Framework 

draft guidance document, FDA proposes 

to continue to exercise enforcement 

discretion for all applicable regulatory 

requirements for LDTs used solely for 

forensic (law enforcement) purposes as 

well as certain LDTs for transplantation 

when used in certified, high-complexity 

histocompatibility laboratories. 

Additionally, FDA proposes to exercise 

enforcement discretion for applicable 

premarket review requirements and 

quality systems (QS) requirements, but 

enforce other applicable regulatory 

requirements, including registration and 

listing (with the option to provide 

notification instead) and adverse event 

reporting, for low-risk LDTs (class I 

devices), LDTs for rare diseases, 

Traditional LDTs and LDTs for Unmet 

Needs, as described in the Framework 

draft guidance document. For other 

high- and moderate-risk LDTs, FDA 

proposes to enforce applicable 

regulatory requirements, including 

registration and listing (with the option 

to provide notification instead) and 

adverse event reporting, and phase in 

enforcement of premarket and QS 

requirements in a risk-based manner. 

With the publication of the draft 

guidances, FDA announced a public 

comment period soliciting feedback on 

all aspects of the guidance documents as 

well as on the following specific issues: 

(1) Factors for ‘‘Traditional LDT’’ and 

appropriate level of enforcement 

discretion for such tests; (2) factors for 

considering LDTs for rare diseases; (3) 

manufacture and use of LDTs solely 

within a healthcare system as a risk 

mitigation supporting some continued 

enforcement discretion; (4) timeframe 

for phase-in enforcement of QS 

regulation requirements for those LDTs 

called in for enforcement of premarket 

review requirements early in the 

implementation period; and (5) the 

appropriateness of a single notification 

for the same LDT manufactured by 

multiple labs owned by a single entity. 

FDA intends to use this public 

workshop as a forum for open 

discussion with all stakeholders 

regarding these specific issues as well as 

other considerations for how to best 

balance patient safety and patient access 

in developing the finalized framework 

in a manner that best serves public 

health. 

II. Topics for Discussion at the Public 

Workshop 

Issues to be considered during the 

sessions include: 

Session 1: Components of a Test and 

LDT Labeling Considerations 

• What components do FDA cleared/ 

approved tests and LDTs typically 

include? 

• What labeling considerations 

should be taken into account for 

LDTs? 

• How does LDT labeling affect and 

not affect physician consultation 

with the laboratory? 

Session 2: Clinical Validity/Intended 

Use 

• What is clinical validity and how is 

it demonstrated for IVDs, including 

LDTs? 

• How are clinical claims or intended 

use related to clinical validity? 

• What types of modifications may 

affect the intended use or 

significantly affect the performance 

of a test? 

Session 3: Categories for Continued 

Enforcement Discretion 

• As a factor for consideration of 

continued enforcement discretion 

for premarket review and QS 

regulation requirements for LDTs 

for rare diseases, the proposed 

framework for LDTs relies on the 

definition of a humanitarian use 

device (HUD) in 21 CFR 

814.102(a)(5). Under this definition, 

an IVD may qualify for HUD 

designation when the number of 

persons in the United States who 

may be tested with the device is 

fewer than 4,000 per year. Is this an 

appropriate factor for LDTs for rare 

diseases? If not, what factor should 

FDA consider for LDTs for rare 

diseases? 

• Should enforcement discretion be 

limited to tests for rare diseases that 

meet the definition of an LDT (a test 

designed, manufactured and used 

within a single laboratory)? 

• Are the following three factors the 

appropriate controls to mitigate 

risks due to Traditional LDTs so 

that continued enforcement 

discretion is appropriate with 

respect to premarket review and 

quality system requirements 

whether the test is: (1) An LDT 

(designed, manufactured and used 

within a single laboratory); (2) 

comprised of only components and 

instruments that are legally 

marketed for clinical use, which 

have a number of regulatory 

controls in place, including 

reporting of adverse events; and (3) 

interpreted by laboratory 

professionals who are appropriately 

qualified and trained as required by 

the CLIA (Clinical Laboratory 

Improvement Amendments) 

regulations (see, e.g., 42 CFR 

493.1449), without the use of 

automated instrumentation or 

software for interpretation? Are 

these three factors also sufficient to 

support continued enforcement 

discretion in full (i.e., for all 

regulatory requirements rather than 

just for premarket review and 

quality system requirements) for 

this category of LDTs? Should FDA 

instead consider different factors? 

• FDA has proposed the following 

three factors for consideration of 

continued enforcement discretion 

for premarket review and QS 

requirements for LDTs for Unmet 

Needs whether: (1) The device 

meets the definition of an LDT (a 

test designed, manufactured and 

used by a single laboratory); (2) 

there is no FDA cleared or approved 

IVD available for that specific 

intended use; and (3) 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 


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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 


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