Proposed Data Collections Submitted for Public Comment and Recommendations, 54284-54285 [E6-15235]
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Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices
identity proofing and user
authentication. For the purposes of the
CPS hearing, identify proofing should
be understood to mean the process of
providing sufficient information (e.g.,
identity history, credentials, and
documents) to correctly and accurately
verify and establish an identity to be
used in an electronic environment (e.g.,
over the Internet). For many everyday
processes such as applying for a
passport or driver’s license, identity
proofing takes place. To be granted the
rights associated with a passport or
driver’s license, one first needs to
provide documents to prove one’s
identity (e.g., birth certificate). This
same principal exists to control access
to electronic systems, and it is the intent
of this hearing to discuss the types of
identity proofing used or recommended
to gain access to certain health IT
products or services.
For the purposes of the CPS hearing,
user authentication should be
understood to mean the process of
reliably verifying a claimed or presented
identity, often used as way to grant
authorized access to data, resources,
and other network services. User
authentication takes place after an
identity has been successfully proofed
(verified by the appropriate authority)
and a credential representing that
proofed identity has been assigned to an
individual. This does not mean the
assignment of a unique identifier, but
rather it refers to the method any system
uses (in a unique way) to differentiate
its users (e.g., a separate username) and
challenge the user’s ability to prove that
they are who they claim to be (e.g.,
knowledge of a password associated
with the username).
While responding to the questions
below, it is recommended that each
response identify (1) The risks and
benefits associated with a particular
identity proofing and/or user
authentication method; (2) the potential
costs and/or barriers associated with the
method’s implementation; and (3) if
feasible, quantify the risks, benefits,
costs, or barriers discussed in parts 1
and 2, with respect to a health care
consumer, provider, other entity, or all.
Responses should be particularly
focused on the Community’s
breakthroughs (pre-populated and
consumer-directed medication history
and registration summary as part of a
personal health record (PHR), access to
current and historical laboratory results
and interpretations in an electronic
health record (EHR), and secure
messages between patients and their
clinicians). Where possible, please
provide references to any peer reviewed
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literature that has informed your
response.
1. Does an in-person identity proofing
process provide greater benefit than
automated, on-line processes, or vice-versa?
Please explain.
2. Identify and particular concerns
regarding the type of information collected
for identity proofing or the storage of such
information.
3. Should there be different identity
proofing and user authentication processes
for:
a. A patient versus a clinician. If yes,
please explain and identify the scenario;
b. The primary user of a PHR versus a
proxy for that user?
4. Are there other industry policies and
practices related to identity proofing and user
authentication and could be used
successfully in any of the Community
identified breakthroughs (see above)? If so,
please described these policies and specify
how these could be implemented in a way
that would minimize the risks and maximize
the benefits as well as how they would
compare to alternative methods in terms of
risks, benefits and feasibility of
implementation.
5. What is the appropriate balance of
access to medical information in electronic
form (through the use of stronger identity
proofing and user authentication) against the
privacy concerns of the consumer/patient? If
possible, please discuss comparable
programs/efforts in the past that have been
successful in doing this?
6. What/how do you see the HHS’s role, if
any, in establishing guidelines for the health
care industry with respect to identity
proofing and user authentication? Or should
the industry self-police in this area?
7. If private industry EHR or PHR services
were to import data from Federal agencies
(who are required either by statute or policy
to protect data in certain ways), would it be
reasonable to expect that the EHR or PHR
service provided would comply with Federal
information security practices?
8. Should the health care industry adopt
the concept of multiple assurance levels
when performing identity proofing and user
authentication functions, similar to what
OMB has defined for the Federal Government
in OMB Memorandum M–04–04? When
responding to this question, please cite, if
possible other models that may exist
specifically for health care?
9. Based on your experience (personal/
organizational) discuss how identity proofing
and user authentication are currently
addressed in the Personal Health Record
(PHR) market from a technical, policy, and
implementation perspective. Please ensure
that your answers identify:
a. How the type of PHR (i.e., who provides/
sponsors the PHR) could impact the identity
proofing and user authentication method
chosen;
b. Who is capable of providing data to the
PHR;
c. The potential impact the type of data
(which may vary in levels of perceived
sensitivity, e.g., a medication history that
lists a drug for an ear infection versus a drug
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for HIV) could have on the identity proofing
and user authentication method chose; and
d. How data is entered into the PHR, for
example, by a health care consumer, or from
a provider through a ‘‘push model’’ where
data is automatically sent to the PHR without
a request by the consumer.
10. Based on your experience (personal/
organizational) with EHR technology, that
can at a minimum provide access to current
and historical laboratory results and
interpretations, should identify proofing and
user authentication methodologies (technical,
policy, and implementation) differentiate
based upon:
a. The reception method of the data
i. For example: Accessing a laboratory’s
secure Web site for results and typing them
into a patient’s EHR vs. automatic population
from the lab to the EHR; and
b. The interconnectivity of the EHR
i. For example: A doctor in a large health
care system may be able to query another
provider’s EHR for data as opposed to
querying the lab directly.
Written testimony submitted by the
public is not required to address all of
the questions listed above, and answers
to any or all of the questions will be
accepted so long as they comply with
the following testimony guidelines.
Persons wishing to submit written
testimony (which should not exceed
eight double-spaced typewritten pages)
should endeavor to submit it by
September 29, 2006.
If you have special needs for the
meeting or require further assistance,
please contact (202) 690–7151 and
reference the CPS meeting.
The meeting will be available via Web
cast at www.eventcenterlive.com/cfmx/
ec/login/login1.cfm?BID=67 [Room
Number: 8285166].
Judith Sparrow,
Director, American Health Information
Community, Office of Programs and
Coordination, Office of the National
Coordinator for Health Information
Technology.
[FR Doc. 06–7657 Filed 9–13–06; 8:45 am]
BILLING CODE 4150–24–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-06–06BO]
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
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54285
Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
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 through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
blood exposures in the operating room
setting, post exposure management and
treatment of blood and body fluid
exposures, and safety culture and
practices. Data from the National
Surveillance System for Health Care
Workers (NaSH) indicate that surgeons
are at high risk for sharps injuries and/
or blood and body fluid exposures.
However, they have the lowest rates of
exposure reporting. The results of the
proposed survey will be used to
determine the nature and frequency of
blood exposures in the operating room
setting and to make recommendations
about mechanisms for improving safety
culture and practices in this setting.
The questionnaire will be sent to a
5% sample of the 99,042 U.S. surgeons
in the American Medical Association’s
physician masterfile. The survey sample
will be stratified by sub-specialty and
geographic region. Assuming a 20%
response rate, the total number of
respondents would be 990. The survey
will take a maximum of 10 minutes to
complete. Therefore, the maximum total
burden hours may reach 165. There is
no cost to the respondents other than
their time.
Proposed Project
Survey of Surgeons on Occupational
Exposure to Blood and Body Fluids—
New—National Center for Infectious
Diseases (NCID), Division of Healthcare
Quality Promotion (DHQP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality
Promotion (DHQP), CDC, defines as its
primary mission the protection of
patients and healthcare personnel
through the promotion of safety, quality,
and value in the healthcare delivery
system. One priority is preventing
transmission of blood borne pathogens
to healthcare personnel during delivery
of medical care. The purpose of this
project is to conduct a survey of
surgeons regarding the occurrence,
reporting, and management of
occupational exposures to blood and
body fluid in the operating room (OR)
setting. Respondents will also be asked
about safety perceptions and practices
during surgery.
The survey is intended to assess the
knowledge, attitudes, and behaviors of
surgeons regarding sharps injuries and
ESTIMATED ANNUALIZED BURDEN HOURS
Respondent
Number of
respondents
Number of responses per
respondent
Average
burden per
response
(in hours)
Total burden
(hours)
Surgeons ..........................................................................................................
990
1
10/60
165
Dated: September 7, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–15235 Filed 9–13–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
FDA 225–06–8402
Memorandum of Understanding
Between the United States Food and
Drug Administration and the National
Cancer Institute
AGENCY:
Food and Drug Administration,
rwilkins on PROD1PC63 with NOTICES
HHS.
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Jkt 208001
ACTION:
Notice.
SUMMARY: The purpose of this
Memorandum of Understanding (MOU)
is to set forth an agreement between the
National Cancer Institute (NCI) and the
Food and Drug Administration (FDA)
(collectively ‘‘the Parties’’, or
individually as a ‘‘Party’’) to develop
and implement the Federal Investigator
Registry of Biomedical Information
Research Data (FIREBIRD), which will
enable clinical investigators, NCI, FDA,
and industry entities sponsoring clinical
trials of investigational drugs
(‘‘Sponsors of Drugs and Biologics’’ or
‘‘Sponsors’’) to manage clinical
investigator information electronically
in a fully secure manner.
DATES: The agreement became effective
August 10, 2006.
FOR FURTHER INFORMATION CONTACT:
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For FDA: Randy Levin, Center for
Drug Evaluation and Research (HF–
18), Food and Drug Administration,
5600 Fishers Lane, rm. 14B–45,
Rockville, MD 20857, 301–827–
7784, FAX: 301–827–1540.
For NCI: Peter Covitz, National Cancer
Institute, 6116 Executive Blvd., rm.
705, Rockville, MD 20892, 301–
402–0326.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
Dated: September 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 71, Number 178 (Thursday, September 14, 2006)]
[Notices]
[Pages 54284-54285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15235]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-06-06BO]
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
[[Page 54285]]
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, 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 through 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
Survey of Surgeons on Occupational Exposure to Blood and Body
Fluids--New--National Center for Infectious Diseases (NCID), Division
of Healthcare Quality Promotion (DHQP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality Promotion (DHQP), CDC, defines
as its primary mission the protection of patients and healthcare
personnel through the promotion of safety, quality, and value in the
healthcare delivery system. One priority is preventing transmission of
blood borne pathogens to healthcare personnel during delivery of
medical care. The purpose of this project is to conduct a survey of
surgeons regarding the occurrence, reporting, and management of
occupational exposures to blood and body fluid in the operating room
(OR) setting. Respondents will also be asked about safety perceptions
and practices during surgery.
The survey is intended to assess the knowledge, attitudes, and
behaviors of surgeons regarding sharps injuries and blood exposures in
the operating room setting, post exposure management and treatment of
blood and body fluid exposures, and safety culture and practices. Data
from the National Surveillance System for Health Care Workers (NaSH)
indicate that surgeons are at high risk for sharps injuries and/or
blood and body fluid exposures. However, they have the lowest rates of
exposure reporting. The results of the proposed survey will be used to
determine the nature and frequency of blood exposures in the operating
room setting and to make recommendations about mechanisms for improving
safety culture and practices in this setting.
The questionnaire will be sent to a 5% sample of the 99,042 U.S.
surgeons in the American Medical Association's physician masterfile.
The survey sample will be stratified by sub-specialty and geographic
region. Assuming a 20% response rate, the total number of respondents
would be 990. The survey will take a maximum of 10 minutes to complete.
Therefore, the maximum total burden hours may reach 165. There is no
cost to the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondent Number of responses per per response Total burden
respondents respondent (in hours) (hours)
----------------------------------------------------------------------------------------------------------------
Surgeons.................................... 990 1 10/60 165
----------------------------------------------------------------------------------------------------------------
Dated: September 7, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-15235 Filed 9-13-06; 8:45 am]
BILLING CODE 4163-18-P
