Att C 60d FRN

Att C_60d FRN.PDF

Select Agent Distribution Activity: Request for Select Agent

Att C 60d FRN

OMB: 0920-0591

Document [pdf]
Download: pdf | pdf
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Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Notices

anticipated that the draft report and
recommendations, as revised in
accordance with public comment and
stakeholder input, will be presented to
the NVAC for deliberation and decision
for adoption in mid- or late 2011.
DATES: To receive consideration,
comments must be received no later
than 5 p.m. EST on April 15, 2011.
ADDRESSES:
(1) The draft report and
recommendations are available on the
Web at http://www.hhs.gov/nvpo/nvac/
subgroups/adultimmunization.
(2) By electronic mail, comments can
be e-mailed to Lauren Wu, National
Vaccine Program Office, at
[email protected].
(3) By mail, comments can be
submitted to: NVAC AIWG Report, c/o
Lauren Wu, National Vaccine Program
Office, 200 Independence Avenue,
Room 715–H, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Mark Grabowsky, National Vaccine
Program Office, 200 Independence
Avenue, Room 715–H, Washington, DC
20201, Attn: NVAC Adult Immunization
Working Group, Telephone (202) 260–
2325; Fax: (202) 690–4631; E-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Over the
past two decades, numerous reports and
sets of recommendations to address the
suboptimal immunization status of
adults have been developed. These have
been issued by a number of groups,
including the NVAC in 1990, 1994, 1997
and 2004; the Institute of Medicine; a
2010 collaboration in between Trust for
America’s Health, the Infectious
Diseases Society of America, and the
Robert Wood Johnson Foundation; the
2007 National Immunization Congress;
as well as by other groups of
independent experts in the field
working with Federal agencies. Despite
these prior efforts, previous reports and
recommendations have not resulted in
sufficient improvements in the current
status of adult immunization in the U.S.
Additionally, recent research has helped
to better identify additional barriers to
adult immunization, and lessons
learned from recent public health
experiences—such as the 2009–10 H1N1
pandemic—make clear the need for
public health infrastructure for adult
vaccines. Prior recommendations have
provided the AIWG with examples of
successes and opportunities for
improvement.
In 2009, the NVAC issued a report
directed to Federal agencies’ adult
immunization programs (http://
www.hhs.gov/nvpo/nvac/subgroups/
nvacadultimmunizations
workinggroupjune2009). The current

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draft report represents the work of the
NVAC on phase two of this process, a
broad examination of the national adult
immunization program in accordance
with the charge ‘‘to develop
recommendations for establishing a
comprehensive, sustainable, national
adult immunization program that will
lead to vaccine-preventable disease
reduction by improving adult
immunization coverage levels.’’ The
NVAC includes representatives from
public health practitioners, medical
providers, health plan payers,
consumers, vaccine manufacturers, and
HHS agencies. Through review of
previous recommendations to improve
adult immunization, a comprehensive
literature review of barriers to adult
immunization, and identification of
gaps in the current adult vaccination
and immunization system, the AIWG
developed draft recommendations to
achieve the charge as noted above.
The draft report describes the vaccinepreventable disease burden among
adults, the current state of the adult
immunization infrastructure, barriers to
adult immunization, and the
conclusions of the AIWG from these
findings. From these conclusions, the
AIWG makes 3 recommendations: (1)
That there be national leadership for an
adult immunization program, (2) That
there be resources allocated for a
national adult immunization program
and action plan implementation, and (3)
That a national strategic plan be
developed for adult immunization. The
report also provides recommended
components of a national adult
immunization program to be included
in an action plan that fall under 5
categories: General infrastructure,
access, provider- or system-based
interventions, increasing community
demand, and research needs.
The final revision of this report will
be shared with the NVAC for their
deliberation and decision for adoption.
Should the NVAC decide to adopt these
recommendations, the report will then
become a report of the NVAC to the
Assistant Secretary for Health.
Dated: March 1, 2011.
Bruce Gellin,
Director, National Vaccine Program Office.
[FR Doc. 2011–4879 Filed 3–3–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–11–0591]

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 404–639–4773 and send comments
to Carol E. Walker, CDC Acting Reports
Clearance Officer, 1600 Clifton Road
NE., MS–D74, Atlanta, Georgia 30333;
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 shall 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
Select Agent Distribution Activity:
Request for Select Agent (OMB Control
No. 0920–0591 exp. 2/28/2011)—
Reinstatement without change—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC), officially established
as a substructure on July 9, 2010.
Background and Brief Description
The Centers for Disease Control and
Prevention is requesting a three year
extension to continue data collection
under the Select Agent Distribution
Activity. The form used for this activity
is currently approved under OMB
Control No. 0920–0591. The purpose of
this data collection is to provide a
systematic and consistent mechanism to
review requests that come to CDC for
Select Agents. The term select agents is
used to describe a limited group of
viruses, bacteria, rickettsia, and toxins

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Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Notices
that have the potential for use as agents
of bioterrorism, inflicting significant
morbidity and mortality on susceptible
populations.
In light of current terrorism concerns
and the significant NIH grant monies
directed toward Select Agent research,
CDC receives hundreds of requests for
Select Agents from researchers. The
approximately 900 applicants are

required to complete an application
form in which they identify themselves
and their institution, provide a
Curriculum Vitae or biographical
sketch, a summary of their research
proposal, and sign indemnification and
material transfer agreement statements.
In this request, CDC is requesting
approval for approximately 450 hours;
no change from the currently approved

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burden. The only correction to this data
collection request is updating the name
of the National Center on the
application form. A user fee will be
collected to recover costs for materials,
handling and shipping (except for
public health laboratories). The cost to
the respondent will vary based on
which agent is requested.

ESTIMATE OF ANNUALIZED BURDEN HOURS
Respondent

Number of respondents

Number of responses per
respondent

Average burden per response
(in hours)

Researcher ......................................................................................................
Total ..........................................................................................................

900
........................

1
........................

30/60
........................

Dated: February 25, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–4948 Filed 3–3–11; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–11–0666]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to [email protected]. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.

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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

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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. 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. The data will be
used to detect changes in the
epidemiology of adverse events
resulting from new and current medical
therapies and changing risks.
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

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Total burden
(in hours)
450
450

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. Finally, there
are many updates, clarifications, and
data collection revisions proposed in
this submission.
CDC is requesting to delete four
currently approved forms that are no
longer needed by the NHSN and add
five new forms
The previously-approved NHSN
package included 47 individual data
collection forms. 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 and 48 total data
collection tools.
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. The
total estimated annual burden hours are
3,914,125.

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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2011-03-09
File Created2011-03-09

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