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

• 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

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BILLING CODE 4150–37–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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.
27 The Unverified List is found on the Web site
http://www.bis.doc.gov/enforcement/unverifiedlist/
unverified_parties.html. It is updated periodically.

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

[60 Day–10–0666]

Records Retention

17:22 Oct 12, 2010

Dated: October 6, 2010.
Kathleen Sebelius,
Secretary, U.S. Department of Health and
Human Services.

Centers for Disease Control and
Prevention

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.

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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.

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;
28 Section 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).

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comments may also be sent by e-mail to
[email protected].
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
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

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.

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

ESTIMATE OF ANNUALIZED BURDEN HOURS
Responses
per
respondent

Burden per
response
(in hours)

Total annual
burden
(in hours)

Respondents

57.100: NHSN Registration Form .........................

Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Staff RN ........................
Registered Nurse (Infection Preventionist).
Staff RN ........................

6,000

1

5/60

500

6,000

1

10/60

1,000

6,000

1

40/60

4,000

5,500

1

1

5,500

6,000

1

5/60

500

6,000

9

35/60

31,500

6,000

36

32/60

115,200

500
6,000

75
27

15/60
32/60

9,375
86,400

6,000

9

4

216,000

Staff RN ........................

6,000

9

5

270,000

Staff RN ........................

6,000

18

5

540,000

Staff RN ........................
Registered Nurse (Infection Preventionist).
Staff RN ........................
Pharmacy Technician ...

500
6,000

12
27

5/60
32/60

500
86,400

6,000
6,000

540
12

10/60
5/60

540,000
6,000

Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).

6,000

100

5/60

50,000

6,000

72

32/60

230,400

6,000

24

10/60

24,000

6,000

240

25/60

600,000

6,000

5

14

420,000

2,000

250

10/60

83,333

57.101: Facility Contact Information .....................
57.103: Patient Safety Component—Annual Facility Survey.
57.104: Patient Safety Component—Outpatient
Dialysis Center Practices Survey.
57.105: Group Contact Information ......................
57.106: Patient Safety Monthly Reporting Plan ...
57.108: Primary Bloodstream Infection (BSI) .......
57.109: Dialysis Event ..........................................
57.114: Urinary Tract Infection (UTI) ....................
57.116: Denominators for Neonatal Intensive
Care Unit (NICU).
57.117: Denominators for Specialty Care Area
(SCA).
57.118: Denominators for Intensive Care Unit
(ICU)/Other locations (not NICU or SCA).
57.119: Denominator for Outpatient Dialysis .......
57.120: Surgical Site Infection (SSI) ....................
57.121: Denominator for Procedure .....................
57.124: Paper form obsolete. See Electronic
Data Upload Specification Tables.
57.125: Central Line Insertion Practices Adherence Monitoring.
57.126: MDRO or CDI Infection Form ..................
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Number of
respondents

Form number and name

57.127: MDRO and CDI Prevention Process and
Outcome Measures Monthly Monitoring.
57.128: Laboratory-identified MDRO or CDI
Event.
57.130: Denominators for Summary Vaccination
Method.
57.133: Patient Vaccination ..................................

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Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Respondents

57.137: Patient Safety Component—Annual Facility Survey for LTCF.
57.138: Laboratory-identified MDRO or CDI
Event for LTCF.
57.139: MDRO and CDI Prevention Process
Measures Monthly Monitoring for LTCF.
57.140: Urinary Tract Infection (UTI) for LTCF ....

Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Registered Nurse (Infection Preventionist).
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Laboratory Technician ..
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Occupational Health
RN/Specialist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.

57.202: Healthcare Worker Survey ......................
57.203: Healthcare Personnel Safety Monthly
Reporting Plan.
57.204: Healthcare Worker Demographic Data ...
57.205: Exposure to Blood/Body Fluids ...............
57.206: Healthcare Worker Prophylaxis/Treatment.
57.207: Follow-Up Laboratory Testing .................
57.208: Healthcare Worker Vaccination History ..
57.210: Healthcare Worker Prophylaxis/Treatment—Influenza.
57.211: Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel.
57.212: Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel.
57.213: Healthcare Personnel Influenza Vaccination Monthly Summary.
57.300: Hemovigilance Module Annual Survey ...
57.301: Hemovigilance Module Monthly Reporting Plan.
57.303: Hemovigilance Module Monthly Reporting Denominators.
57.304: Hemovigilance Adverse Reaction ...........
57.305: Hemovigilance Incident ...........................
Total Est Annual Burden Hours ....................

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]
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Number of
respondents

Form number and name

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

VerDate Mar<15>2010

17:22 Oct 12, 2010

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.......................................

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Fmt 4703

Burden per
response
(in hours)

Total annual
burden
(in hours)

250

1

25/60

104

250

8

30/60

1,000

250

3

7/60

88

250

9

30/60

1,125

600

100

10/60

10,000

600

9

10/60

900

600

200

20/60

40,000

600

50

1

30,000

600

10

15/60

1,500

600
600

100
300

15/60
10/60

15,000
30,000

600

50

10/60

5,000

600

1

10/60

100

600

1

10/60

100

6,000

6

2

72,000

500

1

2

1,000

500

12

2/60

200

500

12

30/60

3,000

500

120

10/60

10,000

500

72

10/60

6,000

........................

........................

........................

3,914,125

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 [email protected].
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

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per
respondent

Sfmt 4703

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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