7800 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 

mission and primary activity are to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. 

HHS issued the Patient Safety Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule relating to the listing and operation 

of PSOs. The Patient Safety Rule 

authorizes AHRQ to list as a PSO an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ if 

it is found to no longer meet the 

requirements of the Patient Safety Act 

and Patient Safety Rule, when a PSO 

chooses to voluntarily relinquish its 

status as a PSO for any reason, or when 

the PSO’s listing expires. Section 

3.108(d) of the Patient Safety Rule 

requires AHRQ to provide public notice 

when it removes an organization from 

the list of federally approved PSOs. 

AHRQ has accepted a notification 

from Verge Patient Safety Organization, 

a component entity of Verge Solutions, 

LLC, PSO number P0118, to voluntarily 

relinquish its status as a PSO. 

Accordingly, Verge Patient Safety 

Organization was delisted effective at 

12:00 Midnight ET (2400) on February 

2, 2016. 

Verge Patient Safety Organization has 

patient safety work product (PSWP) in 

its possession. The PSO will meet the 

requirements of section 3.108(c)(2)(i) of 

the Patient Safety Rule regarding 

notification to providers that have 

reported to the PSO. In addition, 

according to sections 3.108(c)(2)(ii) and 

3.108(b)(3) of the Patient Safety Rule 

regarding disposition of PSWP, the PSO 

has 90 days from the effective date of 

delisting and revocation to complete the 

disposition of PSWP that is currently in 

the PSO’s possession. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

at http://www.pso.ahrq.gov/. 

Sharon B. Arnold, 

AHRQ Deputy Director. 

[FR Doc. 2016–03034 Filed 2–12–16; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2015–0049] 

Notice of Availability of the Final 

Environmental Assessment and a 

Finding of No Significant Impact for 

HHS/CDC Lawrenceville Campus 

Proposed Improvements 2015–2025, 

Lawrenceville, Georgia 

AGENCY: Centers for Disease Control and 

Prevention, Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), within 

the Department of Health and Human 

Services (HHS), is issuing this notice to 

advise the public that HHS/CDC has 

prepared and signed on February 9, 

2016 a Finding of No Significant Impact 

(FONSI) based on the Final 

Environmental Assessment (Final EA) 

for the HHS/CDC Lawrenceville Campus 

Proposed Improvements 2015–2025 on 

the HHS/CDC Lawrenceville Campus, 

Lawrenceville, Georgia. The Final EA 

has been prepared in accordance with 

the National Environmental Policy Act 

of 1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.), the Council on 

Environmental Quality (CEQ) 

implementing regulations (40 CFR 

1500–1508) and the HHS General 

Administration Manual (GAM) Part 30 

Environmental Procedures, dated 

February 25, 2000. 

DATES: The FONSI and Final EA are 

available as February 16, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Copies of the FONSI and/or the Final 

EA or additional information may be 

obtained by contacting Angela Wagner, 

Portfolio Manager, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE., MS–K96, Atlanta, GA 30329. 

Telephone: (770) 488–8170. 

SUPPLEMENTARY INFORMATION: The 

Centers for Disease Control and 

Prevention (CDC) within the U.S. 

Department of Health and Human 

Services (HHS), has prepared an 

Environmental Assessment (EA), to 

assess the potential impacts associated 

with the undertaking of proposed 

improvements on the HHS/CDC’s 

Lawrenceville Campus located at 602 

Webb Gin House Road in Lawrenceville, 

Georgia. The proposed improvements 

include: (1) Building demolition; (2) 

new building construction, including an 

approximately 12,000 gross square feet 

(gsf) Science Support Building, a new 

Transshipping and Receiving Area at 

approximately 2,500 gsf and two new 

small Office Support Buildings at 8,000 

gsf and 6,000 gsf; (3) expansion and 

relocation of parking on campus; and (4) 

the creation of an additional point of 

access to the campus. The proposed 

improvements would be undertaken 

between the time period of 2015 and 

2025 and are contingent on receipt of 

funding. The proposed improvements 

are needed to maintain an appropriate 

facilities quality level on the 

Lawrenceville Campus. 

On August 14, 2015, HHS/CDC 

published a notice in the Federal 

Register (80 FR 48863) announcing the 

availability of a Draft EA and requesting 

public comment. The comment period 

ended on September 28, 2015. No 

substantive comments were received 

that raised specific issues or concerns 

with the methodology, analysis, 

conclusion or accurateness of the EA. 

Based on the analysis of 

environmental impacts in the EA and in 

accordance with NEPA, HHS/CDC has 

determined that the proposed action 

will not significantly affect the human 

or natural environment and therefore 

does not require the preparation of an 

environmental impact statement. 

Dated: February 10, 2016. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2016–03059 Filed 2–12–16; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–0573] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7801 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National HIV Surveillance System 

(NHSS) (OMB Control No. 0920–0573, 

Expires 02/29/2016)—Revision— 

National Center for HIV/AIDS, Viral 

Hepatitis, STD, and TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Data collected as part of the National 

HIV Surveillance System (NHSS) are the 

primary data used to monitor the impact 

of HIV infection in the United States. 

The NHSS provides critical data that are 

used to describe the incidence and 

prevalence of HIV disease and the 

characteristics of infected persons. HIV 

surveillance data are used widely at the 

local, state and national levels for 

planning, evaluation and allocation of 

funding for HIV prevention and care 

programs. 

The NHSS has been updated 

periodically as science, technology, and 

our understanding of HIV has evolved. 

CDC in collaboration with health 

departments in the 50 states, the District 

of Columbia, and U.S. dependent areas, 

conducts national surveillance for cases 

of HIV infection that includes critical 

data across the spectrum of HIV disease 

from HIV diagnosis, to stage 3 (AIDS), 

the end-stage disease caused by 

infection with HIV, and death. In 

addition, this national system provides 

essential data to estimate HIV incidence 

and monitor patterns in HIV drug 

resistance and genetic diversity, as well 

as provide information on perinatal 

exposures in the United States. 

The CDC surveillance case definition 

has been modified periodically to 

accurately monitor disease in adults, 

adolescents and children and reflect use 

of new testing technologies and changes 

in HIV treatment. Information is then 

updated in the case report forms and 

reporting software as needed. 

In 2014, following extensive 

consultation and peer review, CDC and 

the Council of State and Territorial 

Epidemiologists (CSTE) revised and 

combined the surveillance case 

definitions for human 

immunodeficiency virus (HIV) infection 

into a single case definition for persons 

of all ages. Laboratory criteria for 

defining a confirmed case now 

accommodate new multi-test 

algorithms, including criteria for 

differentiating between HIV–1 and HIV– 

2 infection and for recognizing early 

HIV infection. Clinical (non-laboratory) 

criteria for defining a case for 

surveillance purposes have been made 

more practical by eliminating the 

requirement for information about 

laboratory tests. The surveillance case 

definition is intended primarily for 

monitoring the HIV infection burden 

and planning for prevention and care on 

a population level, not as a basis for 

clinical decisions for individual 

patients. CDC and CSTE recommend 

that all states and territories conduct 

case surveillance of HIV infection using 

this revised surveillance case definition. 

Modifications to data elements to 

accommodate the 2014 HIV case 

surveillance definition were approved 

in the last renewal of OMB Control No. 

0920–0573. The revisions requested in 

this extension include modifications to 

currently collected data elements and 

forms to accommodate new testing 

technologies as well as clinical practice 

guidelines. Specifically, the HIV Testing 

and Antiretroviral Use History section 

will be revised on the adult/adolescent 

and pediatric case report forms to 

include new laboratory tests, additional 

information on use of antiretrioviral 

(ARV) medications for pre-exposure 

prophylaxis (PrEP), post-exposure 

prophylaxis (PEP), prevention of 

mother-to-child-transmission among 

HIV infected women during pregnancy, 

and hepatitis B virus (HBV) treatment. 

Other changes include addition of dates 

to the address and patient ID fields to 

better track residence information and 

minor formatting changes to the form 

used for Perinatal HIV Exposure 

Reporting (PHER). 

The revisions to this request also 

include the addition of burden hours for 

annual reporting by health departments 

for the Standards Evaluation Report 

(SER) and Annual Performance Report 

(APR). Findings from these reports are 

used to improve data quality and ensure 

the accuracy, timeliness, and 

completeness of the national HIV 

surveillance, as well as to monitor 

performance and progress in achieving 

both state and national HIV surveillance 

program objectives. Fifty-nine health 

departments funded for HIV 

surveillance will report a Standards 

Evaluation Report (SER) and APR 

annually. 

CDC provides funding for 59 health 

departments to conduct adult and 

pediatric HIV case surveillance and 

report information to CDC. Health 

department staff compile information 

from laboratories, physicians, hospitals, 

clinics and other health care providers 

to complete adult and adolescent and 

pediatric HIV confidential case reports. 

Updates to case reports are also entered 

into an electronic database by health 

departments, as additional information 

may be received from laboratories, vital 

statistics offices, or additional 

providers. Evaluations are also 

conducted by health departments on a 

subset of case reports (e.g., reabstraction/validation activities and 

routine interstate de-duplication) in all 

jurisdictions. 

Supplemental surveillance data are 

collected in a subset of areas to provide 

additional information necessary to 

estimate HIV incidence, to better 

describe the extent of HIV viral 

resistance and quantify HIV subtypes 

among persons infected with HIV and to 

monitor and evaluate perinatal HIV 

prevention efforts. Health departments 

funded for these supplemental data 

collections obtain this information from 

laboratories, health care providers, and 

medical records. CDC estimates that 25 

health departments will be reporting 

data elements containing HIV Incidence 

Surveillance (HIS) data, 53 health 

departments will report additional data 

elements on HIV nucleotide sequences 

as part of Molecular HIV Surveillance 

(MHS), and 35 areas will be reporting 

data as part of 35 health departments 

will be reporting data collected as part 

of Perinatal HIV Exposure Reporting 

(PHER) annually. The total estimated 

annual burden hours are 50,504. 

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7802 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Health Departments ...................................... Adult HIV Case Report ................................. 59 1,061 20/60 

Health Departments ...................................... Pediatric HIV Case Report ........................... 59 5 20/60 

Health Departments ...................................... Case Report Evaluations ............................. 59 107 20/60 

Health Departments ...................................... Case Report Updates ................................... 59 1,576 2/60 

Health Departments ...................................... Laboratory Updates ...................................... 59 6,303 1/60 

Health Departments ...................................... HIV Incidence Surveillance (HIS) ................. 25 2,288 10/60 

Health Departments ...................................... Molecular HIV Surveillance (MHS) .............. 53 829 5/60 

Health Departments ...................................... Perinatal HIV Exposure Reporting (PHER) 35 114 30/60 

Health Departments ...................................... Annual Reporting: Standards Evaluation 

Report (SER).

59 1 8 

Health Departments ...................................... Annual Reporting: Annual Performance Report (APR).59 1 42 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2016–03046 Filed 2–12–16; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0001] 

Food and Drug Administration Clinical 

Trial Requirements, Regulations, 

Compliance, and Good Clinical 

Practices; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public workshop entitled 

‘‘Educational Conference Co-Sponsored 

With the Society of Clinical Research 

Associates (SOCRA).’’ The public 

workshop on FDA’s clinical trial 

requirements is designed to aid the 

Clinical Research Professional’s 

understanding of the mission, 

responsibilities, and authority of FDA 

and to facilitate interaction with FDA 

representatives. The program will focus 

on the relationships among FDA, 

clinical trial staff, investigators, and 

institutional review boards (IRBs). 

Individual FDA representatives will 

discuss the informed consent process 

and informed consent documents; 

regulations relating to drugs, devices, 

and biologics; as well as inspections of 

clinical investigators, of IRBs, and of 

research sponsors. 

DATES: The public workshop will be 

held on March 9 and 10, 2016, from 8 

a.m. to 5 p.m. 

ADDRESSES: The public workshop will 

be held at the Holiday Inn San Diego 

Bayside, 4875 North Harbor Dr., San 

Diego, CA 92106, 619–224–3621. 

FOR FURTHER INFORMATION CONTACT: Jane 

Kreis, Food and Drug Administration, 

1301 Clay St., Suite 1180N, Oakland, 

CA 94612, 510–287–2708, FAX: 510– 

287–2739, or Society of Clinical 

Research Associates (SOCRA), 530 West 

Butler Ave., Suite 109, Chalfont, PA 

18914, telephone: 800–762–7292 or 

215–822–8644, FAX: 215–822–8633, 

Office@socra.org, Web site: 

www.socra.org. (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.) 

SUPPLEMENTARY INFORMATION: 

I. Background 

The public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

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. 

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 workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

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

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The workshop also is consistent 

with the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121), as outreach activities by 

Government Agencies to small 

businesses. 

II. Topics for Discussion at the Public 

Workshop 

Topics for discussion include the 

following: (1) The Role of the FDA 

District Office Relative to the 

Bioresearch Monitoring Program 

(BIMO); (2) Modernizing FDA’s Clinical 

Trials/BIMO; (3) What FDA Expects in 

a Pharmaceutical Clinical Trial; (4) 

Medical Device Aspects of Clinical 

Research; (5) Adverse Event Reporting— 

Science, Regulation, Error, and Safety; 

(6) Working With FDA’s Center for 

Biologics Evaluation and Research; (7) 

Ethical Issues in Subject Enrollment; (8) 

Keeping Informed and Working 

Together; (9) FDA Conduct of Clinical 

Investigator Inspections; (10) 

Investigator Initiated Research; (11) 

Meetings With FDA—Why, When, and 

How; (12) Part 11 Compliance— 

Electronic Signatures; (13) IRB 

Regulations and FDA Inspections; (14) 

Informed Consent Regulations; (15) The 

Inspection is Over—What Happens 

Next? Possible FDA Compliance 

Actions; and (16) Question and Answer 

Session/Panel Discussion. 

Registration: The registration fee will 

cover actual expenses including 

refreshments, lunch, materials, and 

speaker expenses. Seats are limited; 

please submit your registration as soon 

as possible. Workshop space will be 

filled in order of receipt of registration. 

Those accepted into the workshop will 

receive confirmation. The cost of the 

registration is as follows: SOCRA 

member—$575, SOCRA nonmember 

(includes membership)—$650, Federal 

Government member—$450, Federal 

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