Attachment A-5 -- 30 Day Federal Register Notice

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sets and codes for establishment
registration and drug listing
information, including labeling. The
information collection resulting from
this guidance, discussed in the Federal
Register of January 8, 2009 (74 FR 816),
has been approved by OMB under
Control Number 0910–0045. As
discussed in the January 8, 2009,
Federal Register notice, to create an SPL
file and submit it to FDA, a registrant
would need the following tools: A
computer, appropriate software, access
to the Internet, knowledge of
terminology and standards, and access
to FDA’s electronic submission gateway
(ESG). Registrants (and most
individuals) have computers and
Internet access available for their use. If
a business does not have an available
computer or access to the Internet, free
use of computers and the Internet are

usually available at public facilities,
e.g., a community library. In addition,
there should be no additional costs
associated with obtaining the
appropriate software. In 2008, FDA
collaborated with GlobalSubmit to make
available free SPL authoring software
that SPL authors may utilize to create
new SPL documents or edit previous
versions. (Information on obtaining this
software is explained in section IV.A of
the guidance ‘‘Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Listing.’’) In addition to the software,
FDA also provides technical assistance
and other resources, code sets and
codes, and data standards regarding SPL
files.
After the SPL file is created, the
registrant would upload the file through
the ESG, as explained in the January 8,

2009, Federal Register notice. A digital
certificate is needed to use the ESG. The
digital certificate binds together the
owner’s name and a pair of electronic
keys (a public key and a private key)
that can be used to encrypt and sign
documents. A fee of up to $20.00 is
charged for the digital certificate and the
registrant may need to renew the
certificate not less than annually. We
are not calculating this fee as a cost for
this extension because all applicants
who submit content of labeling are also
subject to the drug establishment
registration and listing requirements
and would have already acquired the
digital certificate as a result of the May
2009 guidance on drug establishment
registration and listing.
FDA estimates the burden of this
collection of information as follows:

TABLE 1.
Number of
respondents
Content of labeling submissions in
NDAs, ANDAs, supplemental
NDAs and ANDAs, and annual
reports

Annual frequency
per Response

450

Total Annual
Responses

11.11

Hours per
Response

5,000

Total Hours

1.25

6,250

There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26760 Filed 11–5–09; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality

DATES: Comments on this notice must be
received by December 7, 2009.

Agency Information Collection
Activities: Proposed Collection;
Comment Request

ADDRESSES:

AGENCY: Agency for Healthcare Research
and Quality, HHS.
ACTION:

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to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on September 2nd, 2009 and
allowed 60 days for public comment.
One comment was received. The
purpose of this notice is to allow an
additional 30 days for public comment.

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:
‘‘Collection of Information for Agency
for Healthcare Research and Quality’s
(AHRQ) Hospital Survey on Patient
Safety Culture Comparative Database.’’
In accordance with the Paperwork
Reduction Act of 1995, 44 U.S.C.
3506(c)(2)(A), AHRQ invites the public

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Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by email at [email protected]
(attention: AHRQ’s desk officer).
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
e-mail at [email protected].
SUPPLEMENTARY INFORMATION:

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Proposed Project
Collection of Information for Agency for
Healthcare Research and Quality’s
(AHRQ) Hospital Survey on Patient
Safety Culture Comparative Database
The Agency for Healthcare Research
and Quality (AHRQ) requests that the
Office of Management and Budget
(OMB) approve, under the Paperwork
Reduction Act of 1995, AHRQ’s
collection of information for the AHRQ
Hospital Survey on Patient Safety
Culture (Hospital SOPS) Comparative
Database. The Hospital SOPS
Comparative Database consists of data
from the AHRQ Hospital Survey on
Patient Safety Culture. Hospitals in the
U.S. are asked to voluntarily submit
data from the survey to AHRQ, through
its contractor, Westat. The database was
developed by AHRQ in 2006 in
response to requests from hospitals
interested in knowing how their patient
safety culture survey results compare to
those of other hospitals in their efforts
to improve patient safety.
In 1999, the Institute of Medicine
called for health care organizations to
develop a ‘‘culture of safety’’ in which
their workforces and processes focus on
improving the reliability and safety of
care for patients (IOM, 1999; To Err is
Human: Building a Safer Health

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System). To respond to the need for
tools to assess patient safety culture in
health care, AHRQ developed and pilot
tested the Hospital Survey on Patient
Safety Culture with OMB approval
(OMB No. 0935–0115; Approved 2/4/
2003). The survey was designed to
enable hospitals to assess staff opinions
about patient safety issues, medical
error, and error reporting and includes
42 items that measure 12 dimensions of
patient safety culture. AHRQ released
the survey in the public domain along
with a Survey User’s Guide and other
toolkit materials in November 2004 on
the AHRQ Web site. Since its release,
the survey has been voluntarily used by
hundreds of hospitals in the U.S.
The Hospital SOPS survey and the
Hospital SOPS Comparative Database
are supported by AHRQ to meet its goals
of promoting improvements in the
quality and safety of health care in
hospital settings. This project is
conducted 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 health
statistics, surveys, and database
development. See 42 U.S.C. 299a(a)(1)
and (8). The surveys, toolkit materials,
and comparative database results are all
made available in the public domain
along with technical assistance,
provided by AHRQ through its
contractor at no charge to hospitals, to

facilitate the use of these materials for
hospital patient safety and quality
improvement.
Method of Collection
Information for the Hospital SOPS
database has been collected by AHRQ
on an annual basis since 2006. Hospitals
are asked to voluntarily submit their
Hospital SOPS survey data to the
comparative database between May 1
and June 30. The data are then cleaned
and aggregated and used to produce a
Comparative Database Report that
displays averages, standard deviations,
and percentile scores on the survey’s 42
items and 12 patient safety culture
dimensions, as well as displaying these
results by hospital characteristics (bed
size, teaching status, ownership) and
respondent characteristics (hospital
work area, staff position, and those with
direct interaction with patients). In
addition, trend data, showing changes
in scores over time, are presented from
hospitals that have submitted to the
database more than once.
Estimated Annual Respondent Burden
Hospitals administer the AHRQ
Hospital Survey on Patient Safety
Culture every 16 months on average.
Therefore, the number of hospital
submissions to the database varies each
year because hospitals do not submit
data every year. The 250 respondents/
point-of-contacts (POCs) shown in
Exhibit I are based on an estimated
increase in the number of submissions
in 2010 and 2011 (above the 180

respondents from 2009). Data
submission is typically handled by one
POC who is either a hospital patient
safety manager or a survey vendor. The
POC completes a number of data
submission steps and forms, beginning
with completion of an online Eligibility
and Registration Form. The POCs
typically submit data on behalf of 3
hospitals, on average, because many
hospitals are part of a multi-hospital
system that is submitting data, or the
POC is a vendor that is submitting data
for multiple hospitals. In 2009, 180
POCs submitted data on behalf of a total
of 535 hospitals (an average of 3
hospital submissions per POC). Exhibits
1 and 2 are based on the estimated
number of individual POCs who will
complete the database submission steps
and forms in the coming years, not
based on the number of hospitals. The
Patient Safety Improvement Initiatives
Form is completed only by POCs from
trending hospitals that have submitted
data more than once, so only about half
of the POCs each year will be asked to
complete the form for each of the 3
hospitals (on average) they are
submitting data for. The Hospital
Information Form is completed by all
POCs for each of their hospitals. The
total annual burden hours are estimated
to be 1,508.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to submit their data.
The cost burden is estimated to be
$69,438 annually.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
[Hours total]
Number of
respondents/
POCs

Form name

Number of
response
per POCs

Response
per
response

Total
burden
hours

Eligibility/Registration Form and Data Submission * ........................................
Data Use Agreement .......................................................................................
Patient Safety Improvement Initiatives Form (for trending hospitals only) .....
Hospital Information Form ...............................................................................

250
250
125
250

1
1
3
3

5.6
3/60
5/60
5/60

1,400
13
32
63

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

875

NA

NA

1,508

* The Eligibility and Registration Form requires 3 minutes to complete; however about 5.5 hours is required to prepare/plan for the data submission. This includes the amount of time POCs and other hospital staff (CEO, lawyer, database administrator) typically spend deciding whether
to participate in the database and preparing their materials and data set for submission to the database, and performing the submission.

EXHIBIT 2—ESTIMATED ANNUALIZED COST HOURS
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[Hours total]
Number of
responses
per POCs

Form name
Eligibility/Registration Form and Data Submission ..........................................
Data Use Agreement .......................................................................................
Patient Safety Improvement Initiatives Form (for trending hospitals only) .....
Hospital Information Form ...............................................................................

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Total
burden
hours

250
250
125
250

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1,400
13
32
63

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Average
hourly
wage rate*
$46.11
45.22
45.22
45.22

Total
cost
burden
$64,554
588
1,447
2,849

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Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST HOURS—Continued
[Hours total]
Number of
responses
per POCs

Form name
Total ...................................................................................................

Total
burden
hours

875

1,508

Average
hourly
wage rate*
NA

Total
cost
burden
$69,438

* Wage rates were calculated using the mean hourly wage based on occupational employment and wage estimates from the Dept of Labor,
Bureau of Labor Statistics’ May 2008 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, located at http://www.bls.gov/oes/2008/may/naics3_22000.htm. Wage rate of $46.22 is based on the mean hourly wages for Medical and Health
Services Managers. Wage rate of $46.11 is the weighted mean hourly wage for: Medical and Health Services Managers ($45.22 x 2.6 hours =
$117.57), Lawyers ($62.95 x .5 hours =$31 .48), Chief Executives ($89.16 x .5 hours = $44.58), and Database Administrators ($32.30 x 2 hours
= $64.60) [Weighted mean = ($117.57 + 31.48 + 44.58 + 64.60)/5.6 hours = $258.2315.6 hours = $46.1 1/hour].

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated
annualized cost to the government for
developing, maintaining, and managing
the database and analyzing the data and
producing reports. The cost is estimated
to be $250,000 annually.

EXHIBIT 3—ESTIMATED ANNUALIZED
COST
Cost component
Database Development and
Maintenance ..........................
Data Submission ......................
Data Analysis & Reports ..........
Total ...................................

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0506]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Bar Code Label
Requirement for Human Drug and
$50 000
Biological Products
75,000
125,000
250,000

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
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.

18:23 Nov 05, 2009

BILLING CODE M

Annualized
cost

Request for Comments

VerDate Nov<24>2008

Dated: October 21, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–26673 Filed 11–5–09; 8:45 am]

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AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the bar code label requirements for
human drug and biological products.
DATES: Submit written or electronic
comments on the collection of
information by January 5, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to http://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane., rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.

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FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
[email protected], 301–
796–3792.

Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’ s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.

SUPPLEMENTARY INFORMATION:

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