Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 65411 

appropriate agency meetings with 

medical product sponsors and 

investigators; and (2) exploring means to 

provide for identification of patient 

representatives who do not have any, or 

have minimal, financial interests in the 

medical products industry.’’ 

FDA has formed an Agency-wide 

working group to explore approaches 

and procedures as well as to align 

strategies across the Agency for patient 

participation in accordance with the 

statute. Involvement of the patient 

community brings the unique 

perspective of patients, family members, 

caregivers, and patient advocates to the 

decision-making processes of the FDA, 

and FDA is currently using a variety of 

tools to help ensure that the patient 

community is involved in medical 

product discussions to enhance benefitrisk assessment. FDA assesses the 

benefit-risk of new drugs and certain 

devices on a case-by-case basis. In this 

assessment, FDA may consider, among 

other things, the degree of unmet 

medical need and the severity and 

morbidity of the condition or disease 

the drug or device is intended to treat 

or diagnose. This approach has been 

critical to increasing patient access to 

new treatments for cancer, other serious 

diseases, and rare diseases, where 

existing therapies have been few and 

limited in their effectiveness. 

Currently, patient representatives can 

serve as Special Government Employees 

(SGEs) in order to participate as a 

member of an FDA’s federal advisory 

committee meeting about medical 

products undergoing the FDA review 

process for marketing approval and 

other regulatory issues. Patient 

representatives serve as committee 

members on advisory committees 

managed by the Office of the 

Commissioner, Center for Drug 

Evaluation and Research, Center for 

Biologics Evaluation and Research, and 

Center for Devices and Radiological 

Health. SGE patient representatives may 

also serve on special assignments to 

provide feedback and perspective on 

product reviews in progress. These SGE 

activities are in addition to the many 

other activities in which FDA obtains 

patient perspectives, such as open 

public hearings on specific diseases or 

drug development issues, and as 

speakers at FDA-sponsored conferences 

and workshops. 

FDASIA includes the reauthorization 

of the Prescription Drug User Fee Act 

(PDUFA) that provides FDA with the 

necessary resources to maintain a 

predictable and efficient review process 

for human drug and biological products. 

This is the fifth authorization of PDUFA 

(otherwise known as ‘‘PDUFA V’’), 

which was, as directed by Congress, 

developed in consultation with drug 

industry representatives, patient and 

consumer advocates, health care 

professionals, and other public 

stakeholders. Under PDUFA V, FDA 

intends to conduct at least 20 public 

meetings that aim to more 

systematically gather patients’ 

perspectives on their conditions and 

available therapies to treat those 

conditions (Patient Focused Drug 

Development). PDUFA V also includes 

an initiative to enhance FDA’s review of 

patient-reported outcome study 

endpoints and endpoint assessment 

tools. 

FDASIA also includes the 

reauthorization of the Medical Device 

User Fee Act (MDUFA) that provides 

FDA the necessary resources to increase 

the efficiency of regulatory processes in 

order to reduce the time it takes to bring 

safe and effective medical devices to the 

U.S. market. This third authorization of 

MDUFA (otherwise known as ‘‘MDUFA 

III’’), was a result of more than a year 

of public input, negotiations with 

industry representatives, and 

discussions with patient and consumer 

stakeholders. Under MDUFA III, FDA 

has established the Patient Preference 

Initiative to provide the information, 

guidance, and framework necessary to 

incorporate patient preferences on the 

benefit-risk tradeoffs of medical devices 

into the full spectrum of medical device 

regulatory processes and to inform 

medical device innovation by the larger 

medical device community. In the 

process, the initiative aims to advance 

the science of measuring medical device 

preferences of patients, caregivers, and 

providers. Once the Patient Preference 

Initiative helps to define or refine the 

methods to measure patient preferences, 

FDA intends to incorporate patient 

views into the total product life cycle of 

medical devices. 

FDA is opening a docket for 30 days 

to provide an opportunity for interested 

stakeholders to submit comments on 

‘‘strategies to solicit the views of 

patients during the medical product 

development process and consider the 

perspectives of patients during 

regulatory discussions’’ under section 

1137 of FDASIA. FDA is interested in 

comments on both current and new 

activities that would involve patient 

participation in regulatory discussions, 

as well as comments on ways to assess 

patient participation activities. 

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. 

Dated: October 29, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26145 Filed 11–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine Drug 

Testing for Federal Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITF) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908); 

September 30, 1997 (62 FR 51118); 

April 13, 2004 (69 FR 19644); November 

25, 2008 (73 FR 71858); December 10, 

2008 (73 FR 75122); and on April 30, 

2010 (75 FR 22809). 

A notice listing all currently HHScertified laboratories and IITFs is 

published in the Federal Register 

during the first week of each month. If 

any laboratory or IITF certification is 

suspended or revoked, the laboratory or 

IITF will be omitted from subsequent 

lists until such time as it is restored to 

full certification under the Mandatory 

Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 

at the end and will be omitted from the 

monthly listing thereafter. 


rmajette on DSK3VPTVN1PROD with NOTICES
65412 Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 

* The Standards Council of Canada (SCC) voted 

to end its Laboratory Accreditation Program for 

Substance Abuse (LAPSA) effective May 12, 1998. 

Laboratories certified through that program were 

accredited to conduct forensic urine drug testing as 

required by U.S. Department of Transportation 

(DOT) regulations. As of that date, the certification 

of those accredited Canadian laboratories will 

continue under DOT authority. The responsibility 

for conducting quarterly performance testing plus 

periodic on-site inspections of those LAPSAaccredited laboratories was transferred to the U.S. 

HHS, with the HHS’ NLCP contractor continuing to 

have an active role in the performance testing and 

laboratory inspection processes. Other Canadian 

laboratories wishing to be considered for the NLCP 

may apply directly to the NLCP contractor just as 

U.S. laboratories do. 

Upon finding a Canadian laboratory to be 

qualified, HHS will recommend that DOT certify 

the laboratory (Federal Register, July 16, 1996) as 

meeting the minimum standards of the Mandatory 

Guidelines published in the Federal Register on 

April 30, 2010 (75 FR 22809). After receiving DOT 

certification, the laboratory will be included in the 

monthly list of HHS-certified laboratories and 

participate in the NLCP certification maintenance 

program. 

This notice is also available on the 

Internet at http://beta.samhsa.gov/

workplace. 

FOR FURTHER INFORMATION CONTACT: 

Giselle Hersh, Division of Workplace 

Programs, SAMHSA/CSAP, Room 7– 

1051, One Choke Cherry Road, 

Rockville, Maryland 20857; 240–276– 

2600 (voice), 240–276–2610 (fax). 

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines were initially 

developed in accordance with Executive 

Order 12564 and section 503 of Public 

Law 100–71. The ‘‘Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs,’’ as amended in the 

revisions listed above, requires strict 

standards that laboratories and IITFs 

must meet in order to conduct drug and 

specimen validity tests on urine 

specimens for federal agencies. 

To become certified, an applicant 

laboratory or IITF must undergo three 

rounds of performance testing plus an 

on-site inspection. To maintain that 

certification, a laboratory or IITF must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories and IITFs in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines. A HHS-certified 

laboratory or IITF must have its letter of 

certification from HHS/SAMHSA 

(formerly: HHS/NIDA), which attests 

that it has met minimum standards. 

In accordance with the Mandatory 

Guidelines dated November 25, 2008 

(73 FR 71858), the following HHScertified laboratories and IITFs meet the 

minimum standards to conduct drug 

and specimen validity tests on urine 

specimens: 

HHS-Certified Instrumented Initial 

Testing Facilities 

Gamma-Dynacare Medical Laboratories, 

6628 50th Street NW., Edmonton, AB 

Canada T6B 2N7, 780–784–1190 

HHS-Certified Laboratories 

ACM Medical Laboratory, Inc., 160 

Elmgrove Park, Rochester, NY 14624, 

585–429–2264 

Aegis Analytical Laboratories, Inc., 345 

Hill Ave., Nashville, TN 37210, 615– 

255–2400 (Formerly: Aegis Sciences 

Corporation, Aegis Analytical 

Laboratories, Inc., Aegis Analytical 

Laboratories) 

Alere Toxicology Services, 1111 Newton 

St., Gretna, LA 70053, 504–361–8989/ 

800–433–3823 (Formerly: Kroll 

Laboratory Specialists, Inc., 

Laboratory Specialists, Inc.) 

Alere Toxicology Services, 450 

Southlake Blvd., Richmond, VA 

23236, 804–378–9130 (Formerly: 

Kroll Laboratory Specialists, Inc., 

Scientific Testing Laboratories, Inc.; 

Kroll Scientific Testing Laboratories, 

Inc.) 

Baptist Medical Center-Toxicology 

Laboratory, 11401 I–30, Little Rock, 

AR 72209–7056, 501–202–2783 

(Formerly: Forensic Toxicology 

Laboratory Baptist Medical Center) 

Clinical Reference Lab, 8433 Quivira 

Road, Lenexa, KS 66215–2802, 800– 

445–6917 

DrugScan, Inc., 200 Precision Road, 

Suite 200, Horsham, PA 19044, 800– 

235–4890 

ElSohly Laboratories, Inc., 5 Industrial 

Park Drive, Oxford, MS 38655, 662– 

236–2609 

Fortes Laboratories, Inc., 25749 SW 

Canyon Creek Road, Suite 600, 

Wilsonville, OR 97070, 503–486–1023 

Gamma-Dynacare Medical 

Laboratories,* A Division of the 

Gamma-Dynacare Laboratory 

Partnership, 245 Pall Mall Street, 

London, ONT, Canada N6A 1P4, 519– 

679–1630 

Laboratory Corporation of America 

Holdings, 7207 N. Gessner Road, 

Houston, TX 77040, 713–856–8288/

800–800–2387 

Laboratory Corporation of America 

Holdings, 69 First Ave., Raritan, NJ 

08869, 908–526–2400/800–437–4986 

(Formerly: Roche Biomedical 

Laboratories, Inc.) 

Laboratory Corporation of America 

Holdings, 1904 Alexander Drive, 

Research Triangle Park, NC 27709, 

919–572–6900/800–833–3984 

(Formerly: LabCorp Occupational 

Testing Services, Inc., CompuChem 

Laboratories, Inc.; CompuChem 

Laboratories, Inc., A Subsidiary of 

Roche Biomedical Laboratory; Roche 

CompuChem Laboratories, Inc., A 

Member of the Roche Group) 

Laboratory Corporation of America 

Holdings, 1120 Main Street, 

Southaven, MS 38671, 866–827–8042/ 

800–233–6339 (Formerly: LabCorp 

Occupational Testing Services, Inc.; 

MedExpress/National Laboratory 

Center) 

LabOne, Inc. d/b/a Quest Diagnostics, 

10101 Renner Blvd., Lenexa, KS 

66219, 913–888–3927/800–873–8845 

(Formerly: Quest Diagnostics 

Incorporated; LabOne, Inc.; Center for 

Laboratory Services, a Division of 

LabOne, Inc.) 

MedTox Laboratories, Inc., 402 W. 

County Road D, St. Paul, MN 55112, 

651–636–7466/800–832–3244 

MetroLab-Legacy Laboratory Services, 

1225 NE 2nd Ave., Portland, OR 

97232, 503–413–5295/800–950–5295 

Minneapolis Veterans Affairs Medical 

Center, Forensic Toxicology 

Laboratory, 1 Veterans Drive, 

Minneapolis, MN 55417, 612–725– 

2088 

National Toxicology Laboratories, Inc., 

1100 California Ave., Bakersfield, CA 

93304, 661–322–4250/800–350–3515 

One Source Toxicology Laboratory, Inc., 

1213 Genoa-Red Bluff, Pasadena, TX 

77504, 888–747–3774 (Formerly: 

University of Texas Medical Branch, 

Clinical Chemistry Division; UTMB 

Pathology-Toxicology Laboratory) 

Pacific Toxicology Laboratories, 9348 

DeSoto Ave., Chatsworth, CA 91311, 

800–328–6942 (Formerly: Centinela 

Hospital Airport Toxicology 

Laboratory) 

Pathology Associates Medical 

Laboratories, 110 West Cliff Dr., 

Spokane, WA 99204, 509–755–8991/

800–541–7891x7 

Phamatech, Inc., 10151 Barnes Canyon 

Road, San Diego, CA 92121, 858–643– 

5555 

Quest Diagnostics Incorporated, 1777 

Montreal Circle, Tucker, GA 30084, 

800–729–6432 (Formerly: SmithKline 

Beecham Clinical Laboratories; 

SmithKline Bio-Science Laboratories) 

Quest Diagnostics Incorporated, 400 

Egypt Road, Norristown, PA 19403, 

610–631–4600/877–642–2216 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories) 

Quest Diagnostics Incorporated, 8401 

Fallbrook Ave., West Hills, CA 91304, 

818–737–6370 (Formerly: SmithKline 

Beecham Clinical Laboratories) 

Redwood Toxicology Laboratory, 

3700650 Westwind Blvd., Santa Rosa, 

CA 95403, 800–255–2159 

Southwest Laboratories, 4625 E. Cotton 

Center Boulevard, Suite 177, Phoenix, 


rmajette on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 65413 

AZ 85040, 602–438–8507/800–279– 

0027 

STERLING Reference Laboratories, 2617 

East L Street, Tacoma, Washington 

98421, 800–442–0438 

US Army Forensic Toxicology Drug 

Testing Laboratory, 2490 Wilson St., 

Fort George G. Meade, MD 20755– 

5235, 301–677–7085 

Summer King, 

Statistician. 

[FR Doc. 2014–26131 Filed 11–3–14; 8:45 am] 

BILLING CODE 4160–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2014–0048] 

President’s National Security 

Telecommunications Advisory 

Committee 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: Committee Management; Notice 

of Partially Closed Federal Advisory 

Committee Meeting. 

SUMMARY: The President’s National 

Security Telecommunications Advisory 

Committee (NSTAC) will meet on 

Wednesday, November 19, 2014, in 

Washington DC The meeting will be 

partially closed to the public. 

DATES: The NSTAC will meet in a 

closed session on Wednesday, 

November 19, 2014, from 8:30 a.m. to 

10:30 a.m. and in an open session on 

Wednesday, November 19, 2014, from 

10:40 a.m. to 2:40 p.m. 

ADDRESSES: The open, public session 

will be held at the Department of 

Homeland Security Immigration and 

Customs Enforcement facility, 500 12th 

Street SW., Washington DC, and will 

begin at 10:40 a.m. For information on 

facilities or services for individuals with 

disabilities, to request special assistance 

at the meeting, or to attend in person 

contact nstac@dhs.gov as soon as 

possible. 

We are inviting public comment on 

the issues the NSTAC will consider, as 

listed in the SUPPLEMENTARY

INFORMATION section below. Associated 

briefing materials that will be discussed 

at the meeting will be available at 

www.dhs.gov/nstac for review as of 

November 5, 2014. Comments must be 

identified by docket number DHS– 

2014–0048 and may be submitted by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Email: NSTAC@dhs.gov. Include 

the docket number in the subject line of 

the message. 

• Fax: 703–235–5962, Attn: Sandy 

Benevides. 

• Mail: Designated Federal Officer, 

National Security Telecommunications 

Advisory Committee, National 

Protection and Programs Directorate, 

Department of Homeland Security, 245 

Murray Lane, Mail Stop 0615, Arlington 

VA 20598–0615. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security’’ and the docket 

number for this action. Comments 

received will be posted without 

alteration at http://www.regulations.gov, 

including any personal information 

provided. 

Docket: For access to the docket to 

read background documents or 

comments received by the NSTAC, go to 

http://www.regulations.gov, referencing 

docket number DHS–2014–0048. 

A public comment period will be held 

during the open portion of the meeting 

on Wednesday, November 19, 2014, 

from 1:35 p.m. to 2:05 p.m., and 

speakers are requested to limit their 

comments to three minutes. Please note 

that the public comment period may 

end before the time indicated, following 

the last call for comments. Contact 

Sandy Benevides at 703–235–5408 or 

Sandra.Benevides@dhs.gov to register as 

a speaker by close of business on 

November 17, 2014. Speakers will be 

accommodated in order of registration 

within the constraints of the time 

allotted to public comment. 

FOR FURTHER INFORMATION CONTACT: 

Helen Jackson, NSTAC Designated 

Federal Officer, Department of 

Homeland Security, telephone (703) 

235–5321 or Helen.Jackson@dhs.gov. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act, 5 U.S.C. 

Appendix. The NSTAC advises the 

President on matters related to national 

security and emergency preparedness 

(NS/EP) telecommunications policy. 

Agenda: The committee will meet in 

the open session to engage in an update 

of the Federal Communications 

Commission’s current priorities; a 

discussion of the Department of Justice’s 

Anti-Trust Guidelines; the current 

priorities and accomplishments of the 

First Responder Network Authority; a 

panel discussion of the 

interdependencies between the 

Communications and Electric Power 

Sector. The NSTAC members will 

deliberate and vote on the NSTAC 

Report to the President on the 

Cybersecurity Implications of the 

Internet of Things and the NSTAC 

Report to the President on Information 

and Communications Technology 

Mobilization. Both reports will be 

available at www.dhs.gov/nstac as of 

November 5, 2014. 

The NSTAC will meet in a closed 

session to hear a classified briefing 

regarding emerging threats to the 

communications infrastructure and to 

discuss the potential future NSTAC 

study topics. 

Basis for Closure: In accordance with 

5 U.S.C. § 552b(c), The Government in 

the Sunshine Act, it has been 

determined that two agenda items 

require closure as the disclosure of the 

information would not be in the public 

interest. 

The first of these agenda items, the 

classified briefing, will provide 

members with information on nationstate capabilities and strategic threats. 

Such threats target national 

communications infrastructure and 

impact industry’s long-term 

competitiveness and growth, as well as 

the Government’s ability to mitigate 

threats. Malicious actors continue to 

advance their techniques to exploit 

critical infrastructure networks and 

poses serious challenges for the 

communications sector. Disclosure of 

these threats would provide criminals 

who wish to intrude into commercial 

and Government networks with 

information on potential vulnerabilities 

and mitigation techniques, also 

weakening existing cybersecurity 

defense tactics. This briefing will be 

classified at the top secret level, thereby 

exempting disclosure of the content by 

statute. Therefore, this portion of the 

meeting is required to be closed 

pursuant to 5 U.S.C. § 552b(c)(1)(A). 

The second agenda item, the 

discussion of potential NSTAC study 

topics, will address areas of critical 

cybersecurity vulnerabilities and 

priorities for Government. Government 

officials will share data with NSTAC 

members on initiatives, assessments, 

and future security requirements across 

public and private networks. The data to 

be shared includes specific 

vulnerabilities within cyberspace that 

affect the Nation’s communications and 

information technology infrastructures 

and proposed mitigation strategies. 

Disclosure of this information to the 

public would provide criminals with an 

incentive to focus on these 

vulnerabilities to increase attacks on our 

cyber and communications networks. 

Therefore, this portion of the meeting is 

likely to significantly frustrate 

implementation of proposed DHS 

actions and is required to be closed 

pursuant to 5 U.S.C. 552b(c)(9)(B). 


rmajette on DSK3VPTVN1PROD with NOTICES