Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Need for Online Medical Device Survey, 41816-41817 [E6-11640]
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41816
Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Ongoing Study Sites
Baseline:
Youth interview .........................................................................................
Caseworker survey ...................................................................................
First Follow Up:
Youth interview .........................................................................................
Caseworker survey ...................................................................................
Program site visit ......................................................................................
Second Follow Up:
Youth interview .........................................................................................
98
4
1
19
1.5
.5
147
38
177
4
50
1
36
1
1.5
.5
1.5
266
72
75
370
1
1.5
555
250
80
1
1
1.5
1.5
375
120
213
50
1
1
1.5
1.5
320
75
200
1
1.5
300
New (5th) Study Site
Baseline:
Youth interview .........................................................................................
Program site visit ......................................................................................
First Follow Up:
Youth interview .........................................................................................
Program site visit ......................................................................................
Second Follow Up:
Youth interview .........................................................................................
Estimated Total Burden Hours: 2,343.
Estimated Annual Burden Hours
(average over three years): 781.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the Information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment
sroberts on PROD1PC70 with NOTICES
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, 725 17th Street, NW.,
Washington, DC 20503, Attn: Desk
Officer for ACR, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: July 18, 2006.
Robert Sargis.
Reports Clearance Officer.
[FR Doc. 06–6405 Filed 7–21–06; 8:45 am]
BILLING CODE 4184–01–M
VerDate Aug<31>2005
17:54 Jul 21, 2006
Jkt 208001
[Docket No. 2005N–0123]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey of Need for
Online Medical Device Survey
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 August 23,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Survey of Need for Online Medical
Device Information
Executive Order 12862 directs
agencies to identify the customers who
are, or should be, served by the agency,
and to survey customers to determine
the kind and quality of services they
want.
This proposed survey will collect data
about the information customers want
when looking up medical devices on the
Internet. It will focus on the ways
individuals find, use, and rate existing
sources of online medical device
information. FDA will use this data to
understand more about its customers
and to make improvements to its own
Web site.
FDA will administer this survey to
individuals who use the Internet to look
for information about medical devices.
The survey will consist of three
components: A screening tool of 5,000
to identify appropriate respondents, an
online survey of 500 customers, and a
telephone followup interview with 50
customers.
In the Federal Register of April 20,
2005 (70 FR 20573), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received
in response to that notice.
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41817
Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR (Or FDA Form #)
Screening Tool
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
5,000
5,000
0.05
250
500
1
500
0.25
125
-
Online Survey
1
-
-
Telephone2
Follow-Up
-
Total
375
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
2This was listed in the FEDERAL REGISTER announcement but is no longer required in the survey.
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11640 Filed 7–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Bar Code Label
Requirement for Human Drug and
Biological Products
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
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 September 22, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane., rm.
VerDate Aug<31>2005
17:54 Jul 21, 2006
Jkt 208001
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
SUPPLEMENTARY INFORMATION:
[Docket No. 2006N–0279]
AGENCY:
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
PO 00000
Frm 00064
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collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Bar Code Label Requirement for
Human Drug and Biological Products
In the Federal Register of February
26, 2004 (69 FR 9120), we issued a new
rule that required human drug product
and biological product labels to have bar
codes. The rule required bar codes on
most human prescription drug products
and on over-the-counter (OTC) drug
products that are dispensed under an
order and commonly used in health care
facilities. The rule also required
machine-readable information on blood
and blood components. For human
prescription drug products and OTC
drug products that are dispensed under
an order and commonly used in health
care facilities, the bar code must contain
the National Drug Code number for the
product. For blood and blood
components, the rule specifies the
minimum contents of the machinereadable information in a format
approved by the Center for Biologics
Evaluation and Research Director as
blood centers have generally agreed
upon the information to be encoded on
the label. The rule is intended to help
reduce the number of medication errors
in hospitals and other health care
settings by allowing health care
professionals to use bar code scanning
equipment to verify that the right drug
(in the right dose and right route of
administration) is being given to the
right patient at the right time.
Most of the information collection
burden resulting from the final rule, as
calculated in table 1 of the final rule (69
FR 9120 at 9149), was a one-time
burden that does not occur after the
rule’s compliance date of April 26,
2006. In addition, some of the
information collection burden estimated
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]]>Agencies
[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Pages 41816-41817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11640]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0123]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey of Need for
Online Medical Device Survey
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 August
23, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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, OMB, Attn: FDA
Desk Officer, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Survey of Need for Online Medical Device Information
Executive Order 12862 directs agencies to identify the customers
who are, or should be, served by the agency, and to survey customers to
determine the kind and quality of services they want.
This proposed survey will collect data about the information
customers want when looking up medical devices on the Internet. It will
focus on the ways individuals find, use, and rate existing sources of
online medical device information. FDA will use this data to understand
more about its customers and to make improvements to its own Web site.
FDA will administer this survey to individuals who use the Internet
to look for information about medical devices. The survey will consist
of three components: A screening tool of 5,000 to identify appropriate
respondents, an online survey of 500 customers, and a telephone
followup interview with 50 customers.
In the Federal Register of April 20, 2005 (70 FR 20573), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received in response to that
notice.
[[Page 41817]]
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR (Or FDA Form ) Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening Tool 5,000 1 5,000 0.05 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Online Survey 500 1 500 0.25 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Telephone\2\ - - - - -
Follow-Up
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 375
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\This was listed in the Federal Register announcement but is no longer required in the survey.
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11640 Filed 7-21-06; 8:45 am]
BILLING CODE 4160-01-S
