Presidential Interagency Working Group on Import Safety; Public Meeting, 50374-50376 [E7-17305]
Download as PDF
50374
Federal Register / Vol. 72, No. 169 / Friday, August 31, 2007 / Notices
Medical Devices: Recommended
Glossary and Educational Outreach to
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use—
Section 502 of the Federal Food, Drug
and Cosmetic Act/Section 351 of the
Public Health Service Act (OMB
Control Number 0910–0553)—Extension
Section 502 of the Federal Food, Drug
and Cosmetic Act (FFD&C Act) (21
U.S.C. 352), among other things,
establishes requirements for the label or
labeling of a medical device so that it is
not misbranded. Section 351 of the
Public Health Service Act (the PHS Act)
(42 U.S.C. 262), establishes
requirements that manufacturers of
biological products must submit a
license application for FDA review and
approval prior to marketing a biological
product for introduction into interstate
commerce.
In the Federal Register of November
30, 2004 (69 FR 69606), FDA published
a notice of availability of the guidance
entitled ‘‘Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use.’’
The guidance document provides
guidance for the voluntary use of
selected symbols in place of text in
labeling. It provides the labeling
guidance required for: (1) In vitro
diagnostic devices (IVDs), intended for
professional use under 21 CFR 809.10,
FDA’s labeling requirements for IVDs
and (2) FDA’s labeling requirements for
biologics, including IVDs under 21 CFR
parts 610 and 660. Under section 502(c)
of the FFD&C Act, a drug or device is
misbranded, ‘‘If any word, statement, or
other information required by or under
authority of this Act to appear on the
label or labeling is not prominently
placed thereon with such
conspicuousness (as compared with
other words, statements, designs, or
devices, in the labeling) and in such
terms as to render it likely to be read
and understood by the ordinary
individual under customary conditions
of purchase and use.’’ The guidance
document recommends that a glossary
of terms accompany each IVD to define
the symbols used on that device’s labels
and/or labeling. Furthermore, the
guidance recommends an educational
outreach effort to enhance the
understanding of newly introduced
symbols. Both the glossary and
educational outreach information will
help to ensure that IVD users will have
enough general familiarity with the
symbols used, as well as provide a quick
reference for available materials, thereby
further ensuring that such labeling
satisfies the labeling requirements under
section 502(c) of the act and section 351
of the PHS Act.
The likely respondents for this
collection of information are IVD
manufacturers who plan to use the
selected symbols in place of text on the
labels and/or labeling of their IVDs.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section 502 of the FFD&C Act/Section 351 of the PHS Act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Glossary
1,742
1
1,742
4
6,9682
Educational Outreach
1,742
1
1,742
6
27,872
Total
34,840
1 There
sroberts on PROD1PC70 with NOTICES
2 One
are no capital costs or operating and maintenance costs associated with this collection of information.
time burden.
The glossary and educational
outreach activities are inclusive of both
domestic and foreign IVD
manufacturers. The Center for Devices
and Radiological Health’s ‘‘Information
Retrieval System’s Registration and
Listing Information’’ database listed the
total number of IVD manufacturers as
1,742. From this total, 1,206 of the IVD
manufacturers were listed as domestic
and 536 were listed as foreign
manufacturers. Consequently, FDA has
based its burden estimate on the
maximum possible number of
manufacturers choosing to implement
the use of symbols in labeling. The
number of hours per response for the
glossary and educational outreach
activities were derived from
consultation with a trade association
and FDA personnel. The 4-hour
estimate for a glossary is based on the
average time necessary for a
manufacturer to modify the glossary for
the specific symbols used in labels or
labeling for the IVDs manufactured. The
16-hour estimate for educational
outreach is inclusive of activities
VerDate Aug<31>2005
00:43 Aug 31, 2007
Jkt 211001
manufacturers used to educate the
various professional users of IVDs
regarding the meaning of the IVD
symbols. Further, this estimate is based
on FDA’s expectation that IVD
manufacturers will jointly sponsor
many more educational outreach
activities.
Dated: August 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–17217 Filed 8–30–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0330]
Presidential Interagency Working
Group on Import Safety; Public
Meeting
Food and Drug Administration,
HHS.
PO 00000
Frm 00053
Fmt 4703
SUMMARY: The Interagency Working
Group on Import Safety (Working
Group) is announcing a public meeting
to identify actions the public and
private sectors can take to promote the
safety of products imported into the
United States. The Working Group was
created by the Executive order on July
18, 2007.
The public meeting will be held
on October 1, 2007, from 8 a.m. to 6
p.m. Persons interested in attending the
meeting in person or by teleconference
must register by September 17, 2007.
See section III.B of the SUPPLEMENTARY
INFORMATION section of this document
for details on how to register. Submit
written or electronic comments by
October 1, 2007.
DATES:
BILLING CODE 4160–01–S
AGENCY:
Notice of public meeting;
request for comments.
ACTION:
Sfmt 4703
The public meeting will be
held in the Jefferson Auditorium, U.S.
Department of Agriculture, 1400
Independence Ave., SW., South Bldg.,
Washington, DC 20090. The public may
ADDRESSES:
E:\FR\FM\31AUN1.SGM
31AUN1
Federal Register / Vol. 72, No. 169 / Friday, August 31, 2007 / Notices
also attend or present at the meeting by
teleconference (audio bridge).
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 either https://www.fda.gov/dockets/
ecomments or https://
www.regulations.gov. All comments
should be identified with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: For
information regarding the meeting or
this notice: Erik Mettler, Office of Policy
(HF–11), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–3360,
FAX: 301–594–6777, e-mail:
erik.mettler@fda.hhs.gov.
sroberts on PROD1PC70 with NOTICES
SUPPLEMENTARY INFORMATION:
I. Background
The Working Group was established
by Executive Order 13439 on July 18,
2007, to conduct a comprehensive
review of current import safety practices
and determine where improvements can
be made. The Working Group, chaired
by the Department of Health and Human
Services’ Secretary Michael O. Leavitt,
is comprised of officials from the
Department of Health and Human
Services; the Department of State; the
Department of the Treasury; the
Department of Justice; the Department
of Agriculture; the Department of
Commerce; the Department of
Transportation; the Department of
Homeland Security; the Office of
Management and Budget; the Office of
the United States Trade Representative;
the Environmental Protection Agency;
and the Consumer Product Safety
Commission.
The mission of the Working Group is
to identify actions and appropriate steps
that can be pursued, within existing
resources, to promote the safety of
imported products, including the
following:
(1) Reviewing or assessing current
procedures and methods aimed at
ensuring the safety of products exported
to the United States; these current
procedures and methods include:
Reviewing existing cooperation with
foreign governments, foreign
manufacturers, and others in the
exporting country’s private sector
regarding their inspection and
certification of exported goods and
factories producing exported goods; and
considering whether additional
initiatives should be undertaken with
respect to exporting countries or
companies;
VerDate Aug<31>2005
00:43 Aug 31, 2007
Jkt 211001
(2) Identifying potential means to
promote all appropriate steps by U.S.
importers to enhance the safety of
imported products, including
identifying best practices by U.S.
importers in selection of foreign
manufacturers, inspecting
manufacturing facilities, inspecting
goods produced on their behalf either
before export or before distribution in
the United States, identifying origin of
products, and safeguarding the supply
chain; and
(3) Surveying authorities and
practices of Federal, State, and local
government agencies regarding the
safety of imports to identify best
practices and enhance coordination
among agencies.
The Working Group plans to release a
Strategic Framework to promote import
safety and deliver this report to the
President by the September 17, 2007,
due date (see DATES). The Working
Group plans to release a followup
Action Plan by mid-November 2007.
This Action Plan will take into
consideration the feedback received
from the public, and recommend
specific actions the Federal Government
and all parties involved can take to
enhance import safety on all levels.
II. Purpose of the Public Meeting
The objective of the Import Safety
public meeting, to be held on October 1,
2007, is to identify and recommend
actions that persons involved in the
production, distribution, importation,
regulation, and use of imported
products, including government,
industry, and consumers can take to
promote the safety of such products.
To help achieve this objective, the
Working Group would like public
comments to address the following
questions:
1. What are the key challenges for
industry, consumers, and foreign, State
and local governments to ensure the
safety of products imported into the
United States?
2. Consistent with the Strategic
Framework, the Working Group will
recommend to the President by
September 17, 2007, what actions
should persons involved in the
production, distribution, importation,
regulation, and use of imported
products, including Federal, State, local
and foreign governments,
manufacturers, distributors, brokers,
importers, and consumers take,
individually or jointly, to promote the
safety of imported products? What
should the Federal government and
others do to implement or facilitate the
implementation of these actions?
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
50375
3. For each action, what is the
benefit(s) of implementing this
recommendation? What is the cost(s) of
implementing this recommendation?
What challenge(s) does it address? Are
there other actions that must or should
be taken first before implementing this
recommendation?
III. What Information Should You
Know About the Meeting?
A. When and Where Will the Meeting
Occur? What Format Will We Use?
Through this document, we are
announcing the convening of a public
meeting to hear recommendations on
actions that can be taken to promote
import safety. Representatives from
member Departments of the Working
Group will preside over the meeting.
We will conduct the meeting on
October 1, 2007, in the Jefferson
Auditorium (see ADDRESSES). The
meeting format will include
presentations by persons registered to
speak.
B. How Do You Register for the Meeting
or Submit Comments?
If you wish to attend the meeting in
person or by teleconference and/or
make a presentation at the meeting,
send an e-mail message to Erik Mettler
(see FOR FURTHER INFORMATION CONTACT)
by close of business on September 17,
2007. Your e-mail should include the
following information: Name, company,
company address, company telephone
number, e-mail address, whether you
will attend the meeting in person or by
teleconference, and whether you wish to
speak at the meeting. We will send you
a confirmation within 2 business days
after we receive your registration
request. Registration is free and will be
on a first-come, first-serve basis.
We also will accept walk-in
registration at the meeting site, but
space is limited, and we will close
registration when maximum seating
capacity (approximately 500) is reached.
We will try to accommodate all
persons who wish to speak. The time
allotted for presentations may depend
on the number of persons who wish to
speak. Individuals will be able to make
a presentation at the meeting either in
person or by teleconference.
Additionally, regardless of whether
you wish to make a presentation or
simply attend the meeting, contact Erik
Mettler (see FOR FURTHER INFORMATION
CONTACT) if you need any special
accommodations (such as wheelchair
access or a sign language interpreter).
If you would like to submit electronic
or written comments, please send your
comments to the Division of Dockets
E:\FR\FM\31AUN1.SGM
31AUN1
50376
Federal Register / Vol. 72, No. 169 / Friday, August 31, 2007 / Notices
Management (see ADDRESSES). Submit a
single copy of electronic comments or
two paper copies of any written
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday. Written or
electronic comments must be received
no later than (see DATES).
C. Will Meeting Transcripts Be
Available?
We will prepare a meeting transcript
and make it available on FDA’s Web site
(https://www.fda.gov/ohrms/dockets)
after the meeting. We anticipate that
transcripts will be available
approximately 21 business days after
the meeting. The transcript will also be
available for public examination at the
Division of Dockets Management (see
ADDRESSES).
Dated: August 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–17305 Filed 8–30–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment
Request; National Physician Survey of
Practices on Diet, Physical Activity,
and Weight Control
SUMMARY: Under the provision of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), National
Cancer Institute (NCI), has submitted to
the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on June 28, 2007,
page 43609 and allowed 60-days for
public comment. One public comment
was received asking about the
possibility of doing studies of autism
rather than the proposed survey. The
comment was out of the scope of this
current project. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection
Title: Physician Survey of Practices on
Diet, Physical Activity, and Weight
Control.
Type of Information Collection
Request: NEW.
Need and Use of Information
Collection: This study will obtain
current, national data on primary care
physicians’ knowledge, attitudes, and
practices related to diet, physical
activity, and weight control. Obesity,
poor diet, and lack of physical activity
are becoming recognized as major
public health problems in the United
States, and have been linked to
increased risk, adverse prognosis, and
poor quality of life for cancer and many
Estimated
number
respondents
Type of respondent
other chronic diseases. The data
collected in this study will support and
further NCI work in monitoring and
evaluating providers’ cancer prevention
knowledge, attitudes, and practices and
their impact on pupulation health, as
well as enable monitoring of progress
toward major cancer control goals. Data
from the survey will be used to profile
existing physician practice, understand
barriers to counseling and referral, and
to inform methods for improving the
utilization of these services for adults
and children. Two questionnaires, one
sent to physicians and one sent to their
practice administrators, will be
administered by mail or telephone to a
randomly-selected national sample of
2,000 physicians belonging to primary
care specialties. Study participants will
be 2,000 practicing physicians who are
family practitioners, general internists,
pediatricians, and obstetrician/
gynecologists and 2,000 practice
administrators.
The annual reporting burden is as
follows: Estimated Number of
Respondents: 4,000; Estimated Number
of Responses per Respondent: 1;
Average Burden Hours Per Response:
.333; and Estimated Total Annual
Burden Hours, Requested: 1,332. The
annualized cost to respondents is
estimated at: $65,048. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Estimated
number
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
Physician ..........................................................................................................
Medical Practice Administrator ........................................................................
2,000
2,000
1
1
0.333
0.333
666
666
Total ..........................................................................................................
4,000
1
........................
1,332
sroberts on PROD1PC70 with NOTICES
* Hourly earnings data are taken from the National Compensation Survey: Occupational Wages in the United States, June 2005, U.S. Department of Labor, U.S. Bureau of Labor Statistics.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(a) Whether the proposed collection of
information is necessary for the
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
VerDate Aug<31>2005
00:43 Aug 31, 2007
Jkt 211001
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 on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT:
Send comments to Ashley Wilder
Smith, Ph.D., M.P.H., Health Sciences
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Specialist, National Cancer Institute,
6130 Executive Blvd., MSC 7344,
Executive Plaza North, Room 4090,
Bethesda, MD 20892–7344. Telephone:
301–451–1843; E-mail:
smithas@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[Federal Register Volume 72, Number 169 (Friday, August 31, 2007)]
[Notices]
[Pages 50374-50376]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17305]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0330]
Presidential Interagency Working Group on Import Safety; Public
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Interagency Working Group on Import Safety (Working Group)
is announcing a public meeting to identify actions the public and
private sectors can take to promote the safety of products imported
into the United States. The Working Group was created by the Executive
order on July 18, 2007.
DATES: The public meeting will be held on October 1, 2007, from 8 a.m.
to 6 p.m. Persons interested in attending the meeting in person or by
teleconference must register by September 17, 2007. See section III.B
of the SUPPLEMENTARY INFORMATION section of this document for details
on how to register. Submit written or electronic comments by October 1,
2007.
ADDRESSES: The public meeting will be held in the Jefferson Auditorium,
U.S. Department of Agriculture, 1400 Independence Ave., SW., South
Bldg., Washington, DC 20090. The public may
[[Page 50375]]
also attend or present at the meeting by teleconference (audio bridge).
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 either https://
www.fda.gov/dockets/ecomments or https://www.regulations.gov. All
comments should be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: For information regarding the meeting
or this notice: Erik Mettler, Office of Policy (HF-11), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360,
FAX: 301-594-6777, e-mail: erik.mettler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Working Group was established by Executive Order 13439 on July
18, 2007, to conduct a comprehensive review of current import safety
practices and determine where improvements can be made. The Working
Group, chaired by the Department of Health and Human Services'
Secretary Michael O. Leavitt, is comprised of officials from the
Department of Health and Human Services; the Department of State; the
Department of the Treasury; the Department of Justice; the Department
of Agriculture; the Department of Commerce; the Department of
Transportation; the Department of Homeland Security; the Office of
Management and Budget; the Office of the United States Trade
Representative; the Environmental Protection Agency; and the Consumer
Product Safety Commission.
The mission of the Working Group is to identify actions and
appropriate steps that can be pursued, within existing resources, to
promote the safety of imported products, including the following:
(1) Reviewing or assessing current procedures and methods aimed at
ensuring the safety of products exported to the United States; these
current procedures and methods include: Reviewing existing cooperation
with foreign governments, foreign manufacturers, and others in the
exporting country's private sector regarding their inspection and
certification of exported goods and factories producing exported goods;
and considering whether additional initiatives should be undertaken
with respect to exporting countries or companies;
(2) Identifying potential means to promote all appropriate steps by
U.S. importers to enhance the safety of imported products, including
identifying best practices by U.S. importers in selection of foreign
manufacturers, inspecting manufacturing facilities, inspecting goods
produced on their behalf either before export or before distribution in
the United States, identifying origin of products, and safeguarding the
supply chain; and
(3) Surveying authorities and practices of Federal, State, and
local government agencies regarding the safety of imports to identify
best practices and enhance coordination among agencies.
The Working Group plans to release a Strategic Framework to promote
import safety and deliver this report to the President by the September
17, 2007, due date (see DATES). The Working Group plans to release a
followup Action Plan by mid-November 2007. This Action Plan will take
into consideration the feedback received from the public, and recommend
specific actions the Federal Government and all parties involved can
take to enhance import safety on all levels.
II. Purpose of the Public Meeting
The objective of the Import Safety public meeting, to be held on
October 1, 2007, is to identify and recommend actions that persons
involved in the production, distribution, importation, regulation, and
use of imported products, including government, industry, and consumers
can take to promote the safety of such products.
To help achieve this objective, the Working Group would like public
comments to address the following questions:
1. What are the key challenges for industry, consumers, and
foreign, State and local governments to ensure the safety of products
imported into the United States?
2. Consistent with the Strategic Framework, the Working Group will
recommend to the President by September 17, 2007, what actions should
persons involved in the production, distribution, importation,
regulation, and use of imported products, including Federal, State,
local and foreign governments, manufacturers, distributors, brokers,
importers, and consumers take, individually or jointly, to promote the
safety of imported products? What should the Federal government and
others do to implement or facilitate the implementation of these
actions?
3. For each action, what is the benefit(s) of implementing this
recommendation? What is the cost(s) of implementing this
recommendation? What challenge(s) does it address? Are there other
actions that must or should be taken first before implementing this
recommendation?
III. What Information Should You Know About the Meeting?
A. When and Where Will the Meeting Occur? What Format Will We Use?
Through this document, we are announcing the convening of a public
meeting to hear recommendations on actions that can be taken to promote
import safety. Representatives from member Departments of the Working
Group will preside over the meeting.
We will conduct the meeting on October 1, 2007, in the Jefferson
Auditorium (see ADDRESSES). The meeting format will include
presentations by persons registered to speak.
B. How Do You Register for the Meeting or Submit Comments?
If you wish to attend the meeting in person or by teleconference
and/or make a presentation at the meeting, send an e-mail message to
Erik Mettler (see FOR FURTHER INFORMATION CONTACT) by close of business
on September 17, 2007. Your e-mail should include the following
information: Name, company, company address, company telephone number,
e-mail address, whether you will attend the meeting in person or by
teleconference, and whether you wish to speak at the meeting. We will
send you a confirmation within 2 business days after we receive your
registration request. Registration is free and will be on a first-come,
first-serve basis.
We also will accept walk-in registration at the meeting site, but
space is limited, and we will close registration when maximum seating
capacity (approximately 500) is reached.
We will try to accommodate all persons who wish to speak. The time
allotted for presentations may depend on the number of persons who wish
to speak. Individuals will be able to make a presentation at the
meeting either in person or by teleconference.
Additionally, regardless of whether you wish to make a presentation
or simply attend the meeting, contact Erik Mettler (see FOR FURTHER
INFORMATION CONTACT) if you need any special accommodations (such as
wheelchair access or a sign language interpreter).
If you would like to submit electronic or written comments, please
send your comments to the Division of Dockets
[[Page 50376]]
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any written comments, except that individuals
may submit one paper copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Written or electronic
comments must be received no later than (see DATES).
C. Will Meeting Transcripts Be Available?
We will prepare a meeting transcript and make it available on FDA's
Web site (https://www.fda.gov/ohrms/dockets) after the meeting. We
anticipate that transcripts will be available approximately 21 business
days after the meeting. The transcript will also be available for
public examination at the Division of Dockets Management (see
ADDRESSES).
Dated: August 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17305 Filed 8-30-07; 8:45 am]
BILLING CODE 4160-01-S