62832 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 

27The Unverified List is found on the Web site 

http://www.bis.doc.gov/enforcement/unverifiedlist/ 

unverified_parties.html. It is updated periodically. 

28Section 3286 specifies that no person shall be 

prosecuted, tried, or punished for any noncapital 

offense involving certain violations unless the 

indictment is found or the information is instituted 

within 8 years after the offense was committed. 

This statute of limitations applies to Title 18 

Section 175(b) (possession of biological agents with 

no reasonable justification). 

• The presence of a party on the UL 

in a transaction is a ‘‘red flag’’ that 

should be resolved before proceeding 

with the transaction.27

• In accordance with the EAR, if an 

order involves an export, both the 

provider and customer are required to 

maintain documentary evidence of the 

transaction and are prohibited from 

misrepresenting or concealing material 

facts in licensing processes and all 

export control documents.23

In order to avoid violating U.S. laws 

and regulations, providers are 

encouraged to check the international 

customer against the most recent 

versions of these lists of proscribed 

entities before filling each order. 

The U.S. Government recommends 

that providers utilize a ‘‘Best Match’’ 

approach to identify sequences unique 

to pathogens, toxins, and genetic 

elements on the Commerce Control List 

for international orders, as well as 

identifying sequences unique to Select 

Agent and Toxins. 

Contacting the U.S. Government 

In cases where follow-up screening 

cannot resolve concerns raised by either 

customer screening or sequence 

screening, or when providers are 

otherwise unsure about whether to fill 

an order, the U.S. Government 

recommends that providers contact 

relevant agencies as described in 

Section VII. 

Customer and Sequence Screening 

Software and Expertise 

Providers should be aware that 

commercially available customer 

screening software packages may not 

necessarily address all aspects of 

customer screening recommended by 

the U.S. Government. 

The U.S. Government recommends 

that: 

• Providers select a sequence 

screening software tool that utilizes a 

local sequence alignment technique. 

• Providers have the necessary 

expertise in-house to perform the 

sequence screenings, analyze the 

results, and conduct the appropriate 

follow-up research to evaluate the 

significance of dubious sequence 

matches. 

Records Retention 

The U.S. Government recommends 

that providers: 

• Retain records of customer orders 

for at least eight years based on the 

statute of limitations set forth by U.S. 

Code of Federal Crimes and Procedures, 

Title 18 Section 3286.28

• Archive the following information: 

customer information (point-of-contact 

name, organization, address, and phone 

number), order sequence information 

(nucleotide sequences ordered, vector 

used), and order information (date 

placed and shipped, shipping address, 

and receiver name). 

• Develop, maintain, and document 

protocols to determine if a sequence 

‘‘hit’’ qualifies as a true ‘‘sequence of 

concern;’’ protocols that are no longer 

current should be maintained for at least 

eight years. 

• Keep screening records of all ‘‘hits’’ 

for at least eight years, even if the order 

was deemed acceptable. 

• Develop, maintain, and document 

their sequence screening protocols 

within company records; protocols that 

are no longer current should be 

maintained for at least eight years. 

• Retain records of any follow-up 

screening, even if the order was 

ultimately filled, for at least eight years. 

Dated: October 6, 2010. 

Kathleen Sebelius, 

Secretary, U.S. Department of Health and 

Human Services. 

[FR Doc. 2010–25728 Filed 10–12–10; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–10–0666] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. 

Alternatively, to obtain a copy of the 

data collection plans and instrument, 

call 404–639–5960 and send comments 

to Carol E. Walker, Acting CDC Reports 

Clearance Officer, 1600 Clifton Road 

NE., MS–D74, Atlanta, Georgia 30333; 

comments may also be sent by e-mail to 

omb@cdc.gov. 

Comments are invited on (a) whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information will have a 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarify of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of information technology. Written 

comments should be received within 60 

days of this notice. 

Proposed Project 

National Healthcare Safety Network 

(NHSN) (OMB No. 0920–0666 exp. 3/ 

31/2012)—Revision—National Center 

for Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The National Healthcare Safety 

Network (NHSN) is a system designed to 

accumulate, exchange, and integrate 

relevant information and resources 

among private and public stakeholders 

to support local and national efforts to 

protect patients and to promote 

healthcare safety. Specifically, the data 

is used to determine the magnitude of 

various healthcare-associated adverse 

events and trends in the rates of these 

events among patients and healthcare 

workers with similar risks. The data will 

be used to detect changes in the 

epidemiology of adverse events 

resulting from new and current medical 

therapies and changing risks. The NHSN 

consists of four components: Patient 

Safety, Healthcare Personnel Safety, 

Biovigilance, and eSurveillance. In 

general, the data reported under the 

Patient Safety Component protocols are 

used to (1) determine the magnitude of 

the healthcare-associated adverse events 

under study, trends in the rates of the 

events, in the distribution of pathogens, 

and in the adherence to prevention 

practices, and (2) to detect changes in 

the epidemiology of adverse events 

resulting from new medical therapies 

and changing patient risks. 

Additionally, reported data will be used 

to describe the epidemiology of 

antimicrobial use and resistance and to 

understand the relationship of 

antimicrobial therapy to this growing 

problem. Under the Healthcare 

Personnel Safety Component protocols, 

data on events—both positive and 

adverse—are used to determine (1) the 

magnitude of adverse events in 

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Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 62833 

healthcare personnel and (2) 

compliance with immunization and 

sharps injuries safety guidelines. Under 

the Biovigilance Component, data on 

adverse reactions and incidents 

associated with blood transfusions are 

used to provide national estimates of 

adverse reactions and incidents. 

This revision submission includes an 

amended Assurance of Confidentiality, 

which required an update of the 

Assurance of Confidentiality language 

on all forms included in the NHSN 

surveillance system. The scope of NHSN 

dialysis surveillance is being expanded 

to include all outpatient dialysis centers 

so that the existing Dialysis Annual 

Survey can be used to facilitate 

prevention objectives set forth in the 

HHS HAI tier 2 Action Plan and to 

assess national practices in all 

Medicare-certified dialysis centers if 

CMS re-establishes this survey method 

(as expected). The Patient Safety (PS) 

Component is being expanded to 

include long-term care facilities to 

facilitate HAI surveillance in this 

setting, for which no standardized 

reporting methodology or mechanism 

currently exists. Four new forms are 

proposed for this purpose. A new form 

is proposed to be added to the 

Healthcare Personnel Safety (HPS) 

Component to facilitate summary 

reporting of influenza vaccination in 

healthcare workers, which is anticipated 

to be required by CMS in the near 

future. In addition to this new form, the 

scope of the HPS Annual Facility 

Survey is being expanded to include all 

acute care facilities that would enroll if 

CMS does implement this requirement. 

The NHSN Antimicrobial Use and 

Resistance module is transitioning from 

manual web entry to electronic data 

upload only, which results in a 

significant decrease to the reporting 

burden for this package. Eight forms that 

are no longer necessary are being 

removed from this information data 

request. Finally, there are many 

updates, clarifications, and data 

collection revisions proposed in this 

submission. 

The previously approved NHSN 

package included 54 individual data 

collection forms; the current revision 

request includes five new forms and the 

removal of eight forms from the 

package. If all proposed revisions are 

approved, the reporting burden will 

decrease by 1,258,119 hours, for a total 

estimated burden of 3,914,125 hours. 

Healthcare institutions that 

participate in NHSN voluntarily report 

their data to CDC using a web browser 

based technology for data entry and data 

management. Data are collected by 

trained surveillance personnel using 

written standardized protocols. 

Participating institutions must have a 

computer capable of supporting an 

Internet service provider (ISP) and 

access to an ISP. There is no cost to 

respondents other than their time. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Form number and name Respondents Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response 

(in hours) 

Total annual 

burden 

(in hours) 

57.100: NHSN Registration Form ......................... Registered Nurse (Infection Preventionist).6,000 1 5/60 500 

57.101: Facility Contact Information ..................... Registered Nurse (Infection Preventionist).6,000 1 10/60 1,000 

57.103: Patient Safety Component—Annual Facility Survey.Registered Nurse (Infection Preventionist).6,000 1 40/60 4,000 

57.104: Patient Safety Component—Outpatient 

Dialysis Center Practices Survey.

Registered Nurse (Infection Preventionist).5,500 1 1 5,500 

57.105: Group Contact Information ...................... Registered Nurse (Infection Preventionist).6,000 1 5/60 500 

57.106: Patient Safety Monthly Reporting Plan ... Registered Nurse (Infection Preventionist).6,000 9 35/60 31,500 

57.108: Primary Bloodstream Infection (BSI) ....... Registered Nurse (Infection Preventionist).6,000 36 32/60 115,200 

57.109: Dialysis Event .......................................... Staff RN ........................ 500 75 15/60 9,375 

57.114: Urinary Tract Infection (UTI) .................... Registered Nurse (Infection Preventionist).6,000 27 32/60 86,400 

57.116: Denominators for Neonatal Intensive 

Care Unit (NICU).

Staff RN ........................ 6,000 9 4 216,000 

57.117: Denominators for Specialty Care Area 

(SCA).

Staff RN ........................ 6,000 9 5 270,000 

57.118: Denominators for Intensive Care Unit 

(ICU)/Other locations (not NICU or SCA).

Staff RN ........................ 6,000 18 5 540,000 

57.119: Denominator for Outpatient Dialysis ....... Staff RN ........................ 500 12 5/60 500 

57.120: Surgical Site Infection (SSI) .................... Registered Nurse (Infection Preventionist).6,000 27 32/60 86,400 

57.121: Denominator for Procedure ..................... Staff RN ........................ 6,000 540 10/60 540,000 

57.124: Paper form obsolete. See Electronic 

Data Upload Specification Tables.

Pharmacy Technician ... 6,000 12 5/60 6,000 

57.125: Central Line Insertion Practices Adherence Monitoring.Registered Nurse (Infection Preventionist).6,000 100 5/60 50,000 

57.126: MDRO or CDI Infection Form .................. Registered Nurse (Infection Preventionist).6,000 72 32/60 230,400 

57.127: MDRO and CDI Prevention Process and 

Outcome Measures Monthly Monitoring.

Registered Nurse (Infection Preventionist).6,000 24 10/60 24,000 

57.128: Laboratory-identified MDRO or CDI 

Event.

Registered Nurse (Infection Preventionist).6,000 240 25/60 600,000 

57.130: Denominators for Summary Vaccination 

Method.

Registered Nurse (Infection Preventionist).6,000 5 14 420,000 

57.133: Patient Vaccination .................................. Registered Nurse (Infection Preventionist).2,000 250 10/60 83,333 

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62834 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 

ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued 

Form number and name Respondents Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response 

(in hours) 

Total annual 

burden 

(in hours) 

57.137: Patient Safety Component—Annual Facility Survey for LTCF.Registered Nurse (Infection Preventionist).250 1 25/60 104 

57.138: Laboratory-identified MDRO or CDI 

Event for LTCF.

Registered Nurse (Infection Preventionist).250 8 30/60 1,000 

57.139: MDRO and CDI Prevention Process 

Measures Monthly Monitoring for LTCF.

Registered Nurse (Infection Preventionist).250 3 7/60 88 

57.140: Urinary Tract Infection (UTI) for LTCF .... Registered Nurse (Infection Preventionist).250 9 30/60 1,125 

57.202: Healthcare Worker Survey ...................... Occupational Health 

RN/Specialist.

600 100 10/60 10,000 

57.203: Healthcare Personnel Safety Monthly 

Reporting Plan.

Occupational Health 

RN/Specialist.

600 9 10/60 900 

57.204: Healthcare Worker Demographic Data ... Occupational Health 

RN/Specialist.

600 200 20/60 40,000 

57.205: Exposure to Blood/Body Fluids ............... Occupational Health 

RN/Specialist.

600 50 1 30,000 

57.206: Healthcare Worker Prophylaxis/Treatment.Occupational Health 

RN/Specialist.

600 10 15/60 1,500 

57.207: Follow-Up Laboratory Testing ................. Laboratory Technician .. 600 100 15/60 15,000 

57.208: Healthcare Worker Vaccination History .. Occupational Health 

RN/Specialist.

600 300 10/60 30,000 

57.210: Healthcare Worker Prophylaxis/Treatment—Influenza.Occupational Health 

RN/Specialist.

600 50 10/60 5,000 

57.211: Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel.Occupational Health 

RN/Specialist.

600 1 10/60 100 

57.212: Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel.Occupational Health 

RN/Specialist.

600 1 10/60 100 

57.213: Healthcare Personnel Influenza Vaccination Monthly Summary.Occupational Health 

RN/Specialist.

6,000 6 2 72,000 

57.300: Hemovigilance Module Annual Survey ... Medical/Clinical Laboratory Technologist.500 1 2 1,000 

57.301: Hemovigilance Module Monthly Reporting Plan.Medical/Clinical Laboratory Technologist.500 12 2/60 200 

57.303: Hemovigilance Module Monthly Reporting Denominators.Medical/Clinical Laboratory Technologist.500 12 30/60 3,000 

57.304: Hemovigilance Adverse Reaction ........... Medical/Clinical Laboratory Technologist.500 120 10/60 10,000 

57.305: Hemovigilance Incident ........................... Medical/Clinical Laboratory Technologist.500 72 10/60 6,000 

Total Est Annual Burden Hours .................... ....................................... ........................ ........................ ........................ 3,914,125 

Dated: October 5, 2010. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–25695 Filed 10–12–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–11–0729] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed project or to obtain a copy of 

data collection plans and instruments, 

call 404–639–5960 or send comments to 

Carol E. Walker, Acting Reports 

Clearance Officer, 1600 Clifton Road, 

MS D–74, Atlanta, GA 30333 or send an 

e-mail to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Written comments should be received 

within 60 days of this notice. 

Proposed Project 

Customer Surveys Generic Clearance 

for the National Center for Health 

Statistics (0920–0729 exp. 6/30/2009)— 

Reinstatement—National Center for 

Health Statistics (NCHS), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C. 242k), as 

amended, authorizes that the Secretary 

of Health and Human Services (DHHS), 

acting through NCHS, shall collect 

statistics on ‘‘the extent and nature of 

illness and disability of the population 

of the United States.’’ This is a 

reinstatement request for a generic 

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