Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Need for Online Medical Device Information, 20573-20574 [05-7882]
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20573
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Respondent
Total Hours
600.80(c)(1) and (e)
90
168.07
15,126
1
15,126
600.80(c)(2)
90
72.78
6,550
28
183,400
600.81
90
3.59
323
1
355
600.90
5
1
5
1
5
Total
198,886
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Record
Total Annual
Records
Hours per
Recordkeeper
Total Hours
600.12
116
57.16
6,630
32
212,160
600.12(b)(2)
320
6.12
1,958
24
46,992
90
394.27
35,484
1
35,484
600.80(i)
Total
294,636
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7824 Filed 4–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0123]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Survey of Need for
Online Medical Device Information
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a survey of customers who should be
served by FDA’s Center for Devices and
Radiological Health (CDRH) Web site, in
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
order to determine the kind and quality
of services they want.
DATES: Submit written or electronic
comments on the collection of
information by June 20, 2005.
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.
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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
the Federal Register concerning each
proposed 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.
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
E:\FR\FM\20APN1.SGM
20APN1
20574
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Screening tool
5,000
1
5,000
.05
250
Online survey
500
1
500
.25
125
50
1
50
.5
25
Telephone followup
Total
1 There
400
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7882 Filed 4–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0137]
Levothyroxine Sodium Therapeutic
Equivalence; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting on the therapeutic
equivalence of levothyroxine sodium
drug products. This will be a workshop
involving FDA staff and representatives
of three medical societies: The
American Thyroid Association (ATA),
the Endocrine Society, and the
American Association of Clinical
Endocrinologists (AACE). The purpose
of the public meeting is to discuss
FDA’s regulatory standards and
methodological approaches for
determining therapeutic equivalence
between levothyroxine sodium drug
products. The agency is seeking
comments and input from interested
constituencies, including patient
advocacy and education groups, and
pharmaceutical sponsors.
DATES: The public meeting will be held
on May 23, 2005, from 8:30 a.m. to 5
p.m. Submit written or electronic
comments by July 23, 2005.
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
The public meeting will be
held at the National Transportation
Safety Board Boardroom and Conference
Center, 429 L’Enfant Plaza, SW.,
Washington, DC 20594, 202–314–6421.
The center can be reached by Metro
using the L’Enfant Plaza station on the
green, yellow, blue, and orange lines.
For directions, see https://ntsb.gov/
events/newlocation.htm. (FDA has
verified the Web site address, but FDA
is not responsible for any changes to the
Web site after this document publishes
in the Federal Register.)
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/
ecomments.
ADDRESSES:
Rose
Cunningham, Center for Drug
Evaluation and Research (HFD–006),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20852,
301–443–5595, e-mail:
cunninghamr@cder.fda.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 14,
1997 (62 FR 43535), FDA declared that
oral drug products containing
levothyroxine sodium were considered
new drugs and subject to regulation as
such. The document called for new drug
applications (NDAs) for levothyroxine
sodium products from sponsors wishing
to market such products in the United
States after August 14, 2000. This
deadline was eventually extended to
August 14, 2001.
The NDAs submitted for
levothyroxine sodium products
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Frm 00060
Fmt 4703
Sfmt 4703
included literature references
supporting the safety and effectiveness
of levothyroxine sodium for the
proposed indications and full
manufacturing information supporting
the purity, potency, and stability of the
products. Manufacturers were required
to target 100 percent of the labeled
levothyroxine sodium content at release.
(Some manufacturers had historically
added a ‘‘stability overage’’ to give their
products a longer shelf-life.) In addition,
bioavailability and in vitro dissolution
studies were required to establish that
the products were readily and
consistently absorbed across the range
of dosage strengths proposed to be
marketed. To assist manufacturers, in
December 2000, FDA published a
guidance on the conduct of in vivo
pharmacokinetic and bioavailability
studies and in vitro dissolution tests on
these products.
FDA has approved seven NDAs for
levothyroxine sodium products. None
were originally rated as interchangeable
with any other. Since their approval,
FDA has approved supplemental NDAs
from some sponsors demonstrating the
therapeutic equivalence
(interchangeability) of their products to
other approved levothyroxine sodium
products. The agency has also approved
one levothyroxine sodium product
under an abbreviated new drug
application (ANDA).
ATA, the Endocrine Society, and
AACE have questioned FDA’s regulatory
and scientific standards for
determination of therapeutic
equivalence of levothyroxine sodium
products, particularly FDA’s
bioequivalence methodology.
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 70, Number 75 (Wednesday, April 20, 2005)]
[Notices]
[Pages 20573-20574]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7882]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0123]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Survey of Need for Online Medical Device Information
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a survey of customers who should be served
by FDA's Center for Devices and Radiological Health (CDRH) Web site, in
order to determine the kind and quality of services they want.
DATES: Submit written or electronic comments on the collection of
information by June 20, 2005.
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. 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: 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 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.
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
[[Page 20574]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Screening tool 5,000 1 5,000 .05 250
----------------------------------------------------------------------------------------------------------------
Online survey 500 1 500 .25 125
----------------------------------------------------------------------------------------------------------------
Telephone 50 1 50 .5 25
followup
----------------------------------------------------------------------------------------------------------------
Total 400
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7882 Filed 4-19-05; 8:45 am]
BILLING CODE 4160-01-S
