11210 Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices 

Liability and Indemnification: By 

participating in this Challenge, each 

Solver agrees to assume any and all 

risks and waive claims against the 

federal government and its related 

entities, except in the case of willful 

misconduct, for any injury, death, 

damage, or loss of property, revenue, or 

profits, whether direct, indirect, or 

consequential, arising from 

participation in this Challenge, whether 

the injury, death, damage, or loss arises 

through negligence or otherwise. By 

participating in this Challenge, each 

Solver agrees to indemnify the federal 

government against third party claims 

for damages arising from or related to 

Challenge activities. 

Insurance: Based on the subject 

matter of the Challenge, the type of 

work that it will possibly require, as 

well as an analysis of the likelihood of 

any claims for death, bodily injury, or 

property damage, or loss potentially 

resulting from competition 

participation. Solvers are not required to 

obtain liability insurance or 

demonstrate financial responsibility in 

order to participate in this Challenge. 

Privacy, Data Security, Ethics, and 

Compliance: Solvers are required to 

identify and address privacy and 

security issues in their proposed 

projects and describe specific solutions 

for meeting them. In addition to 

complying with appropriate policies, 

procedures, and protections for data that 

ensures all privacy requirements and 

institutional policies are met, use of 

data should not allow the identification 

of the individual from whom the data 

was collected. Solvers are responsible 

for compliance with all applicable 

federal, state, local, and institutional 

laws, regulations, and policies. These 

may include, but are not limited to, 

Health Information Portability and 

Accountability Act (HIPAA) protections, 

Department of Health and Human 

Services (HHS) Protection of Human 

Subjects regulations, and Food and Drug 

Administration (FDA) regulations. It is 

the responsibility of the Solver to obtain 

approvals (e.g., from an Institutional 

Review Board), if required. The 

following links are intended as a 

starting point for addressing regulatory 

requirements but should not be 

interpreted as a complete list of 

resources on these issues: 

HIPAA 

Main link: http://www.hhs.gov/ocr/

privacy/index.html. 

Summary of the HIPAA Privacy Rule: 

http://www.hhs.gov/ocr/privacy/

hipaa/understanding/summary/

index.html. 

Summary of the HIPAA Security Rule: 

http://www.hhs.gov/ocr/privacy/

hipaa/understanding/

srsummary.html. 

Human Subjects—HHS 

Office for Human Research Protections: 

http://www.hhs.gov/ohrp/index.html. 

Protection of Human Subjects 

Regulations: http://www.hhs.gov/

ohrp/humansubjects/guidance/

45cfr46.html. 

Policy & Guidance: http://www.hhs.gov/ 

ohrp/policy/index.html. 

Institutional Review Boards 

&Assurances: http://www.hhs.gov/

ohrp/assurances/index.html. 

Human Subjects—FDA 

Clinical Trials: http://www.fda.gov/ 

ScienceResearch/SpecialTopics/

RunningClinicalTrials/default.htm. 

Office of Good Clinical Practice: 

http://www.fda.gov/AboutFDA/

CentersOffices/

OfficeofMedicalProductsandTobacco/

OfficeofScienceandHealthCoordination/

ucm2018191. 

Consumer Protection—Federal Trade 

Commission 

Bureau of Consumer Protection: 

http://business.ftc.gov/privacy-andsecurity. 

Dated: February 23, 2015. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2015–04254 Filed 2–27–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; The Genetic 

Testing Registry 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on November 25, 

2014, page 70194 and allowed 60 days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The Office 

of the Director (OD), National Institutes 

of Health, may not conduct or sponsor, 

and the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Ms. Sarah Carr, Acting Director, 

Office of Clinical Research and 

Bioethics Policy, Office of Science 

Policy, NIH, 6705 Rockledge Dr., Suite 

750, Bethesda, MD 20892, or call nontoll-free number (301) 496–9838, or 

Email your request, including your 

address to: OCRBP-OSP@od.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Proposed Collection: The Genetic 

Testing Registry, 0925–0651, 

EXTENSION—Office of the Director 

(OD), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: Clinical laboratory tests are 

available for more than 5,000 genetic 

conditions. The Genetic Testing Registry 

(GTR) provides a centralized, online 

location for test developers, 

manufacturers, and researchers to 

voluntarily submit detailed information 

about the availability and scientific 

basis of their genetic tests. The GTR is 

of value to clinicians by providing 

information about the accuracy, 

validity, and usefulness of genetic tests. 

The GTR also highlights evidence gaps 

where additional research is needed. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

5,536. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices 11211 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Laboratory Personnel Using Bulk Submission ..... Minimal Fields ..............

Optional Fields .............

190 

159 

29 

29 

18/60 

14/60 

1,653 

1,076 

Laboratory Personnel Not Using Bulk Submission.Minimal Fields ..............

Optional Fields .............

116 

97 

29 

29 

30/60 

24/60 

1,682 

1,125 

Dated: February 23, 2015. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2015–04255 Filed 2–27–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Institute Board of Scientific Advisors, 

March 11, 2015, 9:00 a.m. to March 11, 

2015, 5:00 p.m., National Institutes of 

Health, Building 31, 31 Center Drive, 

Bethesda, MD 20892 which was 

published in the Federal Register on 

February 19, 2015, 80FR8889. 

This Notice is being amended to 

change the start time of the meeting 

from 9:00 a.m. to 8:30 a.m. The meeting 

is open to the public. 

Dated: February 24, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–04170 Filed 2–27–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Environmental 

Health Sciences Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Advisory 

Environmental Health Sciences Council. 

Date: March 16, 2015. 

Open: March 16, 2015, 11:00 a.m. to 3:00 

p.m. 

Agenda: Discussion of program policies 

and issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T. W. Alexander Drive, Research 

Triangle Park, NC 27709. 

Contact Person: Gwen W Collman, Ph.D., 

Interim Director, Division of Extramural 

Research & Training, National Institutes of 

Health, Nat. Inst. of Environmental Health 

Sciences, 615 Davis Dr., KEY615/3112, 

Research Triangle Park, NC 27709, (919) 541– 

4980, collman@niehs.nih.gov. 

This is the open session rescheduled from 

February 18–19, 2015 meeting, which was 

postponed due to inclement weather. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.niehs.nih.gov/about/boards/naehsc/

index.cfm, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: February 24, 2015. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–04168 Filed 2–27–15; 8:45 am] 

BILLING CODE 4140–01–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. 

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, 


asabaliauskas on DSK5VPTVN1PROD with NOTICES