78934 Federal Register / Vol. 76, No. 244 / Tuesday, December 20, 2011 / Notices 

ANCC/PSNA Provider Reference 

Number: 205–3–A–09. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and email, along 

with a check or money order payable to 

‘‘SoCRA’’. Mail to: SoCRA (see Contact 

for address). To register via the Internet, 

go to http://www.socra.org/html/ 

FDA_Conference.htm. (FDA has verified 

the Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Payment by major credit card is 

accepted (Visa/MasterCard/AMEX 

only). For more information on the 

meeting registration, or for questions on 

the public workshop, contact SoCRA 

(see Contact). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The public 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, IRB inspections, 

electronic record requirements, and 

investigator initiated research. Topics 

for discussion include the following: (1) 

What FDA Expects in a Pharmaceutical 

Clinical Trial; (2) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (3) Part 11 Compliance— 

Electronic Signatures; (4) Informed 

Consent Regulations; (5) IRB 

Regulations and FDA Inspections; (6) 

Keeping Informed and Working 

Together; (7) FDA Conduct of Clinical 

Investigator Inspections; (8) Meetings 

With FDA: Why, When, and How; (9) 

Investigator Initiated Research; (10) 

Medical Device Aspects of Clinical 

Research; (11) Working With FDA’s 

Center for Biologics Evaluation and 

Research; and (12) The Inspection Is 

Over—What Happens Next? Possible 

FDA Compliance Actions. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393), which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Public Law 104–121) as outreach 

activities by Government Agencies to 

small businesses. 

Dated: December 14, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–32435 Filed 12–19–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel RFA Panel: 

Challenge on the Transition from Acute to 

Chronic Neuropathic Pain 

Date: January 9–10, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: John Bishop, Ph.D., 

Scientific Review Officer Center for Scientific 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 5182, MSC 7844, 

Bethesda, MD 20892, (301) 408–9664, 

bishopj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Member 

Conflict: Topics in Infectious Diseases and 

Microbiology 

Date: January 12, 2012. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Liangbiao Zheng, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3202, 

MSC 7808, Bethesda, MD 20892, (301) 996– 

5819, zhengli@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: December 13, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–32520 Filed 12–19–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

Published Privacy Impact 

Assessments on the Web 

AGENCY: Privacy Office, DHS. 

ACTION: Notice of Publication of Privacy 

Impact Assessments (PIA). 

SUMMARY: The Privacy Office of DHS is 

making available seven PIAs on various 

programs and systems in DHS. These 

assessments were approved and 

published on the Privacy Office’s web 

site between September 1, 2011 and 

November 30, 2011. 

DATES: The PIAs will be available on the 

DHS Web site until February 21, 2012, 

after which they may be obtained by 

contacting the DHS Privacy Office 

(contact information below). 

FOR FURTHER INFORMATION CONTACT: 

Mary Ellen Callahan, Chief Privacy 

Officer, Department of Homeland 

Security, Washington, DC 20528, or 

email: pia@hq.dhs.gov. 

SUPPLEMENTARY INFORMATION: Between 

September 1, 2011 and November 30, 

2011, the Chief Privacy Officer of the 

DHS approved and published seven 

Privacy Impact Assessments (PIAs) on 

the DHS Privacy Office web site, 

www.dhs.gov/privacy, under the link for 

‘‘Privacy Impact Assessments.’’ These 

PIAs cover seven separate DHS 

programs. Below is a short summary of 

those programs, indicating the DHS 

component responsible for the system, 

and the date on which the PIA was 

approved. Additional information can 

be found on the web site or by 

contacting the Privacy Office. 

System: DHS/FEMA/PIA–018 

Suspicious Activity Reporting (SAR). 

Component: Federal Emergency 

Management Agency (FEMA). 

Date of approval: September 9, 2011. 

FEMA, a component of DHS, manages 

a process for SAR. This process, 

assigned to FEMA’s Office of the Chief 

Security Officer, is designed to collect, 

investigate, analyze, and report 

suspicious activities to the Federal 

Bureau of Investigation’s (FBI) Joint 


jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 244 / Tuesday, December 20, 2011 / Notices 78935 

Terrorism Task Force, Federal 

Protective Service, and/or other federal, 

state, or local law enforcement 

authorities required to investigate and 

respond to terrorist threats or hazards to 

homeland security. FEMA is conducted 

this PIA because this SAR process 

collects, maintains, and uses PII. 

System: DHS/NPPD/US–VISIT/PIA– 

007(a) Biometric Interoperability 

Between the U.S. Department of 

Homeland Security and the U.S. 

Department of Justice. 

Component: National Protection and 

Programs Directorate (NPPD) and 

United States Visitor and Immigrant 

Status Indicator Technology (US– 

VISIT). 

Date of approval: September 16, 2011. 

In 2006, the US–VISIT Program of 

DHS and the Criminal Justice 

Information Services Division of the 

FBI, Department of Justice (DOJ), 

developed an interoperability project to 

support the sharing of information 

among DHS, DOJ, and their respective 

stakeholders. This PIA update was 

conducted to reflect the expansion of 

DHS–DOJ interoperability to include 

new users and uses not covered. In 

addition, this PIA allows users to access 

more data in IDENT. 

System: DHS/ICE/PIA–031 Alien 

Medical Tracking Systems. 

Component: Immigration and 

Customs Enforcement (ICE). 

Date of approval: September 26, 2011. 

ICE provides medical care to and 

maintains medical records about aliens 

that ICE detains for violations of U.S. 

immigration law. The ICE Health 

Service Corps, a division of ICE’s Office 

of Enforcement and Removal 

Operations, has several information 

technology systems that are used to 

track information from medical records 

for aliens in ICE custody for various 

monitoring and reporting purposes. 

These are the Social Services Database, 

Hospitalization Database, Significant 

Detainee Illness Spreadsheet, Mental 

Health Coordination Database, 

Epidemiology Database, and 

Performance Improvement Database. 

This PIA describes the data maintained 

in these medical tracking systems, the 

purposes for which this information is 

collected and used, and the safeguards 

ICE has implemented to mitigate 

privacy and security risks to PII stored 

in these systems. 

System: DHS/ICE/PIA–004(a) ICE 

Pattern Analysis and Information 

Collection (ICEPIC) Update. 

Component: ICE. 

Date of approval: October 26, 2011. 

ICE has established a system called 

the ICEPIC system. ICEPIC is a toolset 

that assists ICE law enforcement agents 

and analysts in identifying suspect 

identities and discovering possible nonobvious relationships among 

individuals and organizations that are 

indicative of violations of the customs 

and immigration laws as well as 

possible terrorist threats and plots. The 

PIA for ICEPIC was published in 

January 2008. This PIA Update was 

completed to provide transparency 

related to the Law Enforcement 

Information Sharing Service that 

enables law enforcement agencies 

outside DHS to query certain 

information available through ICEPIC. 

Additionally, through LEIS DHS law 

enforcement personnel are able to query 

external law enforcement agencies’ 

sensitive but unclassified law 

enforcement information. 

System: DHS/ICE/PIA–015(c) 

Enforcement Integrated Database 

Update. 

Component: ICE. 

Date of approval: November 7, 2011. 

The Enforcement Integrated Database 

(EID) is a DHS shared common database 

repository for several DHS law 

enforcement and homeland security 

applications. EID captures and 

maintains information related to the 

investigation, arrest, booking, detention, 

and removal of persons encountered 

during immigration and criminal law 

enforcement investigations and 

operations conducted by ICE, U.S. 

Customs and Border Protection, and 

U.S. Citizenship and Immigration 

Services, all components within DHS. 

The PIA for EID was published in 

January 2010. In July 2010, a PIA 

Update for EID was published to 

address an expansion of the information 

entered into EID and the scope of 

external information sharing. This EID 

PIA Update addresses planned changes 

to the types of information shared and 

an added method of sharing. 

System: DHS/S&T/PIA–006 Protected 

Repository for the Defense of 

Infrastructure Against Cyber Threats 

(PREDICT). 

Component: Science and Technology. 

Date of approval: November 8, 2011. 

The S&T Directorate’s PREDICT 

system has undergone a PIA 3–Year 

Review. The PIA requires no changes 

and continues to accurately relate to its 

stated mission. PREDICT is a repository 

of test datasets of Internet traffic data 

that is made available to approved 

researchers and managed by an outside 

contractor serving as the PREDICT 

Coordination Center. The goal of 

PREDICT is to create a national research 

and development resource to bridge the 

gap between (a) the producers of 

security-relevant network operations 

data and (b) technology developers and 

evaluators who can use this data to 

accelerate the design, production, and 

evaluation of next-generation cyber 

security solutions, including 

commercial products. 

System: DHS/ALL/PIA–013(a) PRISM 

System Update. 

Component: DHS. 

Date of approval: November 10, 2011. 

DHS Management Directorate, Office 

of the Chief Procurement Officer is the 

owner of the PRISM contract writing 

management system. PRISM provides 

comprehensive, Federal Acquisition 

Regulation-based acquisition support for 

all DHS headquarters entities. The 

purpose of this PIA update is to reflect 

changes to the collection of information, 

and the addition of a classified PRISM 

system. 

Dated: December 12, 2011. 

Mary Ellen Callahan, 

Chief Privacy Officer, Department of 

Homeland Security. 

[FR Doc. 2011–32483 Filed 12–19–11; 8:45 am] 

BILLING CODE 9110–9L–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2011–0040; OMB No. 

1660–0045] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Inspection of 

Insured Structures by Communities 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: The Federal Emergency 

Management Agency, as part of its 

continuing effort to reduce paperwork 

and respondent burden, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on a proposed extension, 

without change, of a currently approved 

collection. In accordance with the 

Paperwork Reduction Act of 1995, this 

notice seeks comments concerning 

extension of the Inspection of Insured 

Structures by Communities. The 

community inspection report requires 

that FEMA consult with local officials 

and others in Monroe County, Village of 

Islamorada, and the City of Marathon 

following any hurricane that may hit the 

Florida Keys, concerning compliance of 

insured buildings with the community’s 

floodplain management ordinance. 


jlentini on DSK4TPTVN1PROD with NOTICES