Attachment H -- 60 Day FR Notice

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Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices

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: February 17, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–3958 Filed 2–25–09; 8:45 am]
BILLING CODE 4160–90–M

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

Notice.

SUMMARY: 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:
‘‘Understanding Patients’ Knowledge
and Use of Acetaminophen.’’ In
accordance with the Paperwork
Reduction Act of 1995, 44 U.S.C.
3506(c)(2)(A), AHRQ invites the public
to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by April 27, 2009.

Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@ahrq.hhs.gov.
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.
ADDRESSES:

FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at doris.lefkowitz@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:

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Proposed Project
‘‘Understanding Patients’ Knowledge
and Use of Acetaminophen’’
This proposed data collection is a
qualitative study to preliminarily
identify issues that relate to the misuse
and overdosing of over-the-counter
(OTC) acetaminophen. Toxicity from
acetaminophen has been on the rise in
the past 3 decades, and is now the most
common cause of acute liver failure in
the U.S., surpassing viral hepatitis. This
data collection has two aims. Aim 1 is
to qualitatively explore knowledge,
attitudes, beliefs, and practices
regarding adult and adolescent selfadministration of OTC acetaminophen,
and parental administration of OTC
acetaminophen to children. To meet
Aim 1, focus groups will be conducted
with adults and semi-structured
interviews will be conducted with
adolescents. Aim 2 is to qualitatively
explore experiences and practices of key
professional informants, including
physicians and pharmacists, with
respect to communicating information
on the administration and risks of OTC
acetaminophen to consumers and
patients. Semi-structured interviews
will be conducted with target key
informants. The results of this
qualitative study will provide an
understanding of the relevant issues and
will be used to develop a
comprehensive survey. A second OMB
clearance package will be developed
once the questionnaire for the survey is
available.
This project is being funded by AHRQ
pursuant to a cooperative agreement
with the University of Pennsylvania
(Award 1 U18HS017991) as part of the
Centers for Education and Research on
Therapeutics (CERTs) program. The
CERTs program is a national initiative,
administered by AHRQ in consultation
with the Food and Drug Administration,
to increase awareness of the benefits
and risks of new, existing, or combined
uses of therapeutics through education
and research. See 42 U.S.C. 299b–1(b).
Method of Collection
Aim 1—Focus groups and individual
interviews
Four focus groups will be conducted
with parents of young children to
examine administration of
acetaminophen to children. Four focus
groups will also be conducted with
adults to identify the issues, barriers,
and psychosocial factors surrounding
how, when, and why OTC
acetaminophen is used. Focus groups
will each have 6 to 8 participants. Semistructured interviews will be conducted

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with adolescents to examine selfadministration of acetaminophen among
this group.
Content areas to be explored are: a.
Knowledge about acetaminophen:
Brands, terms, combinations, dosage,
administration, indications; b. beliefs
about benefits and risks, including
thresholds for toxicity and death; c.
patterns and frequency of use; d.
sources of information (e.g., physicians,
pharmacists, media); e. related
experiences in peers (e.g., advice,
reports of toxicity); and f. views about
labeling, packaging and legislation (e.g.,
restrictions in sales).
Aim 2—Semi-structured interviews with
physicians and pharmacists
Twenty primary care physicians and
20 pharmacists will be interviewed.
Primary care physicians will be
recruited through a primary care
research network of physicians from
both private and public clinics.
Pharmacists will be recruited at
pharmacy facilities from hospitals and
clinics. Interviews will be conducted
over the phone or in person, according
to the participant’s preference, and will
last approximately 20 minutes. All
interviews will be audio-taped and
transcribed. Participants will be asked
about the following: a. Frequency and
patterns of interaction with consumers
and patients with respect to
acetaminophen; b. types of information
provided to consumers; c. availability of
education materials; and d. views about
labeling, packaging and legislation.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
project. The screening form will be
completed by all participants and is
expected to take approximately 3
minutes to complete. Focus groups will
include 2 populations: Parents of
children 8 years of age and adults, and
will last about 11⁄2 hours. Semistructured interviews will be conducted
with 20 adolescents, 20 primary care
physicians, and 20 pharmacists and will
last 20 to 30 minutes. The selfadministered questionnaire will be
completed by the focus group
participants and the adolescent
participants of the semi-structured
interviews, and will take about 6
minutes to complete. The total burden
for all participants is estimated to be
134 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondent’s time to participate in the
project. The total cost is estimated to be
$2,001.

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Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Data collection mode

Hours per
response

Total burden
hours

Screening form ................................................................................
Self-administered questionnaire ......................................................
Focus group with parents of children <8 years of age (4 groups of
8 participants) ...............................................................................
Focus group with adults (4 groups of 8 participants) ......................
Semi-structured interviews with adolescents (13 to 20 years of
age) ..............................................................................................
Semi-structured interviews with primary care physicians ................
Semi-structured interviews with pharmacists ..................................

124
84

1
1

3/60
6/60

6
8

32
32

1
1

1.5
1.5

48
48

20
20
20

1
1
1

30/60
20/60
20/60

10
7
7

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

332

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

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

134

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Data collection mode

Total burden
hours

Average hourly
wage rate*

Total cost burden

Screening form ................................................................................
Self-administered questionnaire ......................................................
Focus groups with parents of children <8 years of age (4 groups
of 8 participants) ..........................................................................
Focus groups with adults (4 groups of 8 participants) ....................
Semi-structured interviews with adolescents (13 to 20 years of
age) ..............................................................................................
Semi-structured interviews with primary care physicians ................
Semi-structured interviews with pharmacists ..................................

124
84

6
8

$10.30
10.30

$62
82

32
32

48
48

10.30
10.30

494
494

20
20
20

10
7
7

10.30
61.10
48.22

103
428
338

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

332

134

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

2,001

* Patient average hourly wage based on the average per capita income of $21,435 (computed into an hourly wage rate of $10.30) in Harris
County, Texas where the study will take place. Provider hourly wage based on the following estimates from National Compensation Survey: Occupational wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics: Primary care physician = $61.10/hour; pharmacist = $48.22/hour.

Estimates of Annualized Cost to the
Government
Exhibit 3 shows the estimated cost to
the Federal Government for this six
month project.
The total cost is $164,440. This
amount includes all direct and indirect
costs of the design, data collection,
analysis, and reporting phase of the
study.

EXHIBIT 3—ESTIMATED COST
Cost component

Total cost

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

$13,250
61,699
14,080
750
17,000
57,661

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

164,440

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
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

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AHRQ health care research, quality
improvement and 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: February 17, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–3959 Filed 2–25–09; 8:45 am]
BILLING CODE 4160–90–M

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0631]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Recall Authority
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 30,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,

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