Attachment G - Federal Register Notice

pmangrum on DSK3VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices
Commissioned Corps Support Services
to the Office of the Surgeon General
(ACM). The changes are as follows:
I. Under Part A, Chapter AC, Office of
the Assistant Secretary for Health, make
the following changes:
A. Under Section AC.20, Functions,
‘‘I. Office of Surgeon General (ACM),
Section ACM.20 Functions, (c) Division
of Commissioned Corps Personnel and
Readiness (ACM2), 3. Assignments &
Career Management Branch (ACM23)’’
add the following functions, beginning
with (13) through (22):
3. Assignments and Career
Management Branch (ACM23). (13)
Administers a payroll system for active
duty Commissioned Corps officers of
basic pay, allowances, and special or
incentive pay in coordination with the
Departments of Defense, Veterans
Affairs, and Treasury; (14) Administers
a pay system for retired Commissioned
Corps officers and survivor annuitants
in coordination with the Departments of
Veterans Affairs and Treasury; (15)
Administrative management of active
duty Commissioned Corps officer
healthcare and support for healthcare
authorization and access to care; (16)
Provides pre-retirement counseling,
conducts retirement boards, determines
eligibility for retirement, processes
retirements, and recalls retirees to active
duty; (17) Administration of periodic,
separation and retirement health
evaluations; (18) Review and award of
Combat-Related Special Pay,
Servicemembers’ Group Life Insurance
Traumatic Injury Protection Program,
and Line of Duty determinations; (19)
Management and support of ongoing
medical and behavioral health
challenges among active duty officers;
(20) Management of fitness for duty and
disability evaluations and
determinations; (21) Administration of
medical waiver evaluations and
issuances; and (22) Management of
Medical Evaluation and Appeal Boards.
B. Under Section AC.20, Functions,
‘‘I. Office of Surgeon General (ACM),
Section ACM.20 Functions, (e) Division
of Systems Integration (ACM6), add the
following functions, beginning with (4)
through (9):
(e) Division of Systems Integration
(ACM6). (4) Certifies monthly
Commissioned Corps payroll to
Treasury; (5) Administers supplemental
and third-party payments to Treasury;
(6) Reviews payroll reports, identifies
potential payroll-related issues, and
validates the monthly Commissioned
Corps payroll; (7) Provides data
reporting and data extracts to HHS and
other governmental organizations and
agencies; (8) Maintains Commissioned
Corps personnel data systems and

VerDate Mar<15>2010

15:25 Oct 04, 2012

Jkt 229001

ensures integrity and availability of
personnel and operational data; and (9)
Maintains Commissioned Corps Web
sites and ensures 508 compliance.
II. Continuation of Policy: Except as
inconsistent with this reorganization, all
statements of policy and interpretations
with respect to the Commissioned Corps
of the PHS heretofore issued and in
effect prior to this reorganization are
continued in full force and effect.
III. Delegations of Authority.
Directives and orders of the Secretary,
Assistant Secretary for Health, or
Surgeon General and all delegations and
re-delegations of authority previously
made to officials and employees of the
affected organizational components will
continue in them or their successors
pending further re-delegation, provided
they are consistent with this
reorganization. All delegated authorities
associated with or necessary to
administer, operate, and manage
transferred entities affected by this
reorganization are transferred to the
Assistant Secretary for Health and may
be re-delegated.
IV. Funds, Personnel, and Equipment.
Transfer of organizations and functions
affected by this reorganization shall be
accompanied by direct and support
funds, positions, personnel, records,
equipment, supplies, and other
resources.
Dated: September 21, 2012.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 2012–24564 Filed 10–4–12; 8:45 am]
BILLING CODE 4150–28–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Development of a Health Information
Rating System (HIRS).’’ In accordance
with the Paperwork Reduction Act, 44
U.S.C. 3501–3521, AHRQ invites the
public to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by December 4, 2012.
SUMMARY:

PO 00000

Frm 00033

Fmt 4703

Sfmt 4703

60997

Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at [email protected].
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at [email protected].
SUPPLEMENTARY INFORMATION:
ADDRESSES:

Proposed Project
Development of a Health Information
Rating System (HIRS)
Over the past several years, low
health literacy has been identified as an
important health care quality issue.
Healthy People 2010 defined health
literacy as ‘‘the degree to which
individuals have the capacity to obtain,
process, and understand basic health
information and services needed to
make appropriate health decisions.’’ In
2003, the Institute of Medicine
identified health literacy as a crosscutting area for health care quality
improvement. According to the 2003
National Assessment of Adult Literacy,
only 12 percent of adults have proficient
health literacy.
Persons with limited health literacy
face numerous health care challenges.
They often have a poor understanding of
basic medical vocabulary and health
care concepts. A study of patients in a
large public hospital showed that 26
percent did not understand when their
next appointment was scheduled and 42
percent did not understand instructions
to ‘‘take medication on an empty
stomach.’’ In addition, limited health
literacy leads to more medication errors,
more and longer hospital stays, and a
generally higher level of illness,
resulting in an estimated excess cost for
the US health care system of $50 billion
to $73 billion per year.
Health care providers can improve
their patients’ health outcomes by
delivering the right information at the
right time in the right way to help
patients prevent or manage chronic
conditions such as diabetes,
cardiovascular disease, hypertension,
and asthma. Electronic health records
(EHRs) can help providers offer patients
the right information at the right time
during office visits, by directly
connecting patients to helpful resources
on treatment and self-management.
EHRs can also facilitate clinicians’ use
of patient health education materials in
the clinical encounter. However, health
education materials delivered by EHRs,

E:\FR\FM\05OCN1.SGM

05OCN1

pmangrum on DSK3VPTVN1PROD with NOTICES

60998

Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices

when available, are rarely written in a
way that is understandable and
actionable for patients with basic or
below basic health literacy—an
estimated 77 million people in the
United States.
In order to fulfill the promise of EHRs
for all patients, especially for persons
with limited health literacy, clinicians
should have a method to determine how
easy a health education material is for
patients to understand and act on, have
access to a library of easy-to-understand
and actionable materials, understand
the relevant capabilities and features of
EHRs to provide effective patient
education, and be made aware of these
resources and information. Therefore,
AHRQ developed a project that includes
the following four major tasks: (1)
Develop a valid and reliable Health
Information Rating System (HIRS), (2)
create a library of patient health
education materials, (3) review EHR’s
patient education capabilities and
features, and (4) educate EHR vendors
and users. This project relates to the
first task only.
As a first step, AHRQ has developed
a draft HIRS using the following
rigorous multistage approach that draws
upon existing rating systems, the
evidence base in the literature, and the
real-world expertise and experience of a
Technical Expert Panel (TEP):
(1) Gather and synthesize evidence on
existing rating systems and literature on
consumers’ understanding of health
information. Seek TEP review of the
summary of existing health information
rating systems. Develop item pool for
each domain—understandability and
actionability, defined as follows:
• Health education materials are
understandable when consumers of
diverse backgrounds and varying
degrees of health literacy can process
and explain key messages.
• Health education materials are
actionable when consumers of diverse
backgrounds and varying levels of
health literacy can identify what they
can do based on the information
presented.
(2) Assess the face and content
validity of the domains (i.e.,
understandability and actionability)
with the TEP.
(3) Assess the inter-rater reliability of
the HIRS on English-language health
education materials. Seek TEP review of
results and provide guidance on how to
address discrepancies.
The draft HIRS was used by AHRQ
researchers to rate 2 sets of patient
health education materials: A set of 6
education materials related to asthma
and a set of 6 education materials
related to colonoscopy. Each of these 12

VerDate Mar<15>2010

15:25 Oct 04, 2012

Jkt 229001

health education materials received a
score for their understandability and
actionability. Some of the materials
received good scores on the draft HIRS,
meaning that the researchers considered
them to be understandable or
actionable, and some materials received
poor scores on the draft HIRS,
indicating that the materials had low
understandability or low actionability.
The final stage of developing a
reliable and valid rating system to assess
the understandability and actionability
of health education materials is testing
with consumers.
This project has the following goals:
(1) To assess the construct validity of
AHRQ’s draft HIRS. The 12 rated health
education materials will be tested with
a total of 48 English-speaking
consumers. Consumers will review
materials and be asked questions to test
whether they understand the materials
and whether they know what actions to
take. The outcome of this testing will be
an HIRS that will offer professionals
(e.g., clinicians, health librarians, etc.) a
systematic method to evaluate and
compare the understandability and
actionability of health education
materials. Since actionability is a new
domain, we are testing it distinct from
understandability though there is a
theoretical relationship between the
domains as we have defined them; that
is, a material cannot be actionable if it
is not first understandable. So
actionability may in fact be a subdomain of understandability. Besides
assessing the construct validity,
consumer testing will help us determine
how to revise and improve the HIRS.
(2) Finalize the HIRS and instructions
for users, and make them publicly
available on AHRQ’s Web site.
This study is being conducted by
AHRQ through its contractor, Abt
Associates, pursuant to AHRQ’s
statutory authority to conduct and
support research on health care and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of health care
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of the project the
following data collections and activities
will be implemented:
(1) Demographic Questionnaire—The
demographic questionnaire will collect
basic demographic information about
each participant. This data will allow
the analysis to detect differences in
health literacy by population subgroups.

PO 00000

Frm 00034

Fmt 4703

Sfmt 4703

(2) Short Test of Functional Health
Literacy in Adults (S–TOFHLA)
Questionnaire—The S–TOFHLA will be
administered once to all participants to
assess their level of health literacy.
(3) Health Education Materials &
Questionnaire—Asthma/Inhaler—This
includes a set of educational materials
related to asthma and proper use of
inhalers. Each consumer will be
randomly assigned one of the six
following materials:
(i) An audiovisual material
(understandable and actionable), titled
How to use an inhaler by the Utah
Department Health Asthma Program.
(ii) An audiovisual material
(understandable and poorly actionable),
titled Asthma Triggers by Children’s
Healthcare of Atlanta.
(iii) An audiovisual material (poorly
understandable), titled Asthma Inhaler
Medication Technique—How to Take an
Asthma Inhaler by America’s Allergist.
(iv) A printable material
(understandable and actionable), titled
Asthma: How to Use A Metered Dose
Inhaler, by FamilyDoctor.org.
(v) A printable material
(understandable and poorly actionable),
titled How to use an inhaler—no spacer,
by MedlinePlus.
(vi) A printable material (poorly
understandable), titled Inhaled Asthma
Medications: Tips to Remember, by the
American Academy of Allergy Asthma
& Immunology.
After seeing the randomly assigned
audiovisual or printable material the
participants will be administered a brief
questionnaire to assess their
understanding of how to use an inhaler
and what actions to take based on the
material.
(4) Health Education Materials &
Questionnaire—Colonoscopy—This
includes a set of educational materials
related to colonoscopy. Each consumer
will be randomly assigned one of the six
following materials:
(i) An audiovisual material
(understandable and actionable), titled
Colonoscopy Patient Education Video
by Krames.
(ii) An audiovisual material
(understandable and poorly actionable),
titled Colorectal Cancer Awareness by
St. Vincent’s Healthcare.
(iii) An audiovisual material (poorly
understandable), titled Prepare for a
Colonoscopy by The University of Texas
MD Anderson Cancer Center.
(iv) A printable material
(understandable and actionable), titled
Getting Ready for Your Colonoscopy by
West Chester Endoscopy Suite.
(v) A printable material
(understandable and poorly actionable),
titled Colonoscopy in the National

E:\FR\FM\05OCN1.SGM

05OCN1

60999

Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices
Digestive Diseases Information
Clearinghouse (NDDIC).
(vi) A printable material (poorly
understandable), titled Colonoscopy by
the American College of Surgeons
Division of Education.
After viewing the randomly assigned
audiovisual or printable material the
participants will be administered a brief
questionnaire to assess their
understanding of a colonoscopy and
what actions to take based on the
material.
The data collected from this project
will be used to assess the construct
validity of and inform revisions to the
HIRS. The HIRS will be the first
instrument that can assess the
understandability and actionability of
patient health education materials that

can be incorporated into an EHR,
including printable and audiovisual
materials. Note that the materials to be
assessed need not currently be
incorporated into EHRs; for now, we are
focusing on materials that have the
potential to be incorporated into EHRs.
No claim is made that the results from
this study will be generalizable in the
statistical sense. Rather, the consumer
testing will be informative and critical
to ensuring we have developed a valid
rating system by conducting consumer
testing.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
annualized burden hours for the
participants’ time to participate in this
research. The Demographic and S–
TOFHLA questionnaires will be

completed by all 48 participants and
takes 5 and 7 minutes, respectively, to
complete. Each of the 48 participants
will review 2 different health education
materials and then answer the
associated questionnaires for each
material topic. Participants will review
English-language materials related to
inhaler use and colonoscopy. To review
each material and answer the associated
questionnaire requires 30 minutes (15
minutes to review the materials and 15
minutes to complete the questionnaire).
The total annualized burden is
estimated to be 58 hours.
Exhibit 2 presents the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated at $1,237.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Data collection

Number of
responses per
respondent

Hours per
response

Total burden
hours

Demographic Questionnaire ............................................................................
S–TOFHLA Questionnaire ...............................................................................
Health Education Materials & Questionnaire—Inhaler ....................................
Health Education Materials & Questionnaire—Colonoscopy ..........................

48
48
48
48

1
1
1
1

5/60
7/60
30/60
30/60

4
6
24
24

Total ..........................................................................................................

192

na

na

58

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Data collection

Total burden
hours

Average
hourly wage
rate*

Total cost
burden

Demographic Questionnaire ............................................................................
S–TOFHLA Questionnaire ...............................................................................
Health Education Materials & Questionnaire—Inhaler ....................................
Health Education Materials & Questionnaire—Colonoscopy ..........................

48
48
48
48

4
6
24
24

$21.35
21.35
21.35
21.35

$85
128
512
512

Total ..........................................................................................................

192

58

na

1,237

* Based upon the mean wage for all occupations, National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S.
Department of Labor, Bureau of Labor Statistics.’’

Estimated Annual Costs to the Federal
Government
The total cost of this contract to the
government is $524,945, and the project

extends over 3 years (July 19, 2010 to
July 18, 2013). The data collection for
which we are seeking OMB clearance
will take place from February 1, 2013 to
March 31, 2013. Exhibit 3 shows a

breakdown of the total cost as well as
the annualized cost for the data
collection, processing and analysis
activity for this entire contract.

EXHIBIT 3—ESTIMATED COST

pmangrum on DSK3VPTVN1PROD with NOTICES

Cost component

Total cost

Annual cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................

$66,447
129,547
129,548
131,571
67,832

$22,149
43,182
43,183
43,857
22,611

Total ..................................................................................................................................................................

524,945

174,982

VerDate Mar<15>2010

15:25 Oct 04, 2012

Jkt 229001

PO 00000

Frm 00035

Fmt 4703

Sfmt 4703

E:\FR\FM\05OCN1.SGM

05OCN1

61000

Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: September 27, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–24454 Filed 10–4–12; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:

In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. App. 2, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality.
DATES: The meeting will be held on
Friday, November 9, 2012, from 8:30
a.m. to 3:30 p.m.
ADDRESSES: The meeting will be held at
the Eisenberg Conference Center,
Agency for Healthcare Research and
Quality, 540 Gaither Road, Rockville,
Maryland 20850.
FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Coordinator of the
Advisory Council, at the Agency for
Healthcare Research and Quality, 540

pmangrum on DSK3VPTVN1PROD with NOTICES

SUMMARY:

VerDate Mar<15>2010

15:25 Oct 04, 2012

Jkt 229001

Gaither Road, Rockville, Maryland
20850, (301) 427–1456. For press-related
information, please contact Alison Hunt
at (301) 427–1244.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than Friday,
October 26, 2012. The agenda, roster,
and minutes are available from Ms.
Bonnie Campbell, Committee
Management Officer, Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850. Ms. Campbell’s phone number is
(301) 427–1554.
SUPPLEMENTARY INFORMATION:
I. Purpose
The National Advisory Council for
Healthcare Research and Quality is
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to AHRQ’s
conduct of its mission including
providing guidance on (A) priorities for
health care research, (B) the field of
health care research including training
needs and information dissemination on
health care quality and (C) the role of
the Agency in light of private sector
activity and opportunities for public
private partnerships.
The Council is composed of members
of the public, appointed by the
Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Friday, November 9, 2012, there
will be a subcommittee meeting for the
National Healthcare Quality and
Disparities Report scheduled to begin at
7:30 a.m. The Council meeting will
convene at 8:30 a.m., with the call to
order by the Council Chair and approval
of previous Council summary notes. The
meeting will begin with a report from
the National Advisory Council
Subcommittee on the Children’s Health
Insurance Program Reauthorization Act.
The AHRQ Director will then present
her update on current research,
programs, and initiatives. Following the
morning session, the Council will hold
an Executive Session between the hours
of 12:00 p.m. and 1:30 p.m. to discuss
strategic issues related to the Agency for
Healthcare Research and Quality. This
Executive Session will be closed to the

PO 00000

Frm 00036

Fmt 4703

Sfmt 4703

public in accordance with 5 U.S.C. App.
2, section 10(d) and 5 U.S.C.
552b(c)(9)(B). This portion of the
meeting is likely to disclose information
the premature disclosure of which
would be likely to significantly frustrate
implementation of a proposed agency
action to the public. The final agenda
will be available on the AHRQ Web site
at www.AHRQ.gov no later than Friday,
November 2, 2012.
Dated: September 27, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–24455 Filed 10–4–12; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention—Health Disparities
Subcommittee (HDS)
In accordance with section 10(a) (2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned subcommittee:
Time and Date: 10 a.m.–12:15 p.m.
EDT, October 24, 2012.
Place: Teleconference.
Status: Open to the public, limited
only by the availability of telephone
ports. The public is welcome to
participate during the public comment
period. A public comment period is
tentatively scheduled for 12 p.m. to
12:15 p.m. To participate in the
teleconference, please dial (866) 561–
5277 and enter code 2238494.
Purpose: The Subcommittee will
provide advice to the CDC Director
through the ACD on strategic and other
health disparities and health equity
issues and provide guidance on
opportunities for CDC.
Matters to be discussed: Agenda items
will include the following: Office of
Minority Health and Health Equity
updates; discussion of draft
recommendations from April 2012
meeting with the IOM Health Disparities
Roundtable; discussion of Critical issues
and Recommendations (Strategies to
Strengthen CDC Response to Social
Determinants of Health and Inequities);
discussion regarding organizing the
workflow of the HDS going forward; and
HDS membership after June 2013.
The agenda is subject to change as
priorities dictate.

E:\FR\FM\05OCN1.SGM

05OCN1