Draft Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability, 60862-60863 [E7-21122]
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60862
Federal Register / Vol. 72, No. 207 / Friday, October 26, 2007 / Notices
before April 28, 2009.1 The agency may
choose not to issue a warning letter or
any further warning prior to taking a
regulatory action against a firm that is
marketing an unapproved exocrine
pancreatic insufficiency drug product
and not actively pursuing approval.
This notice is issued under sections
502 and 505 of the act (21 U.S.C. 352)
and under authority delegated to the
Assistant Commissioner for Policy.
Dated: October 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21082 Filed 10–25–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0364]
Draft Guidance for Industry and Food
and Drug Administration Staff; ImpactResistant Lenses: Questions and
Answers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
SUPPLEMENTARY INFORMATION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Impact-Resistant Lenses:
Questions and Answers.’’ This draft
guidance document answers
manufacturer, importer, and consumer
questions on impact-resistant lenses,
including questions on test procedures,
lens testing apparatus, record
maintenance, and exemptions to testing.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by January 24, 2008.
ADDRESSES: Submit written requests for
single copies of the guidance document
rmajette on PROD1PC64 with NOTICES
SUMMARY:
1 If FDA decides to take enforcement action
against a firm’s unapproved exocrine pancreatic
insufficiency drug product, the agency may at the
same time take action relating to any and all of the
firm’s other violations. For example, if a firm
continues to market an unapproved exocrine
pancreatic insufficiency drug product but fails to
actively pursue approval, to preserve limited
agency resources, FDA may take enforcement action
relating to any and all of the firm’s other
unapproved drugs that require applications (see,
e.g., United States v. Sage Pharmaceuticals, 210 F.
3d 475, 479–480 (5th Cir. 2000) (permitting the
agency to combine all violations of the act in one
proceeding, rather than taking action against
multiple violations of the act in ‘‘piecemeal
fashion’’)).
VerDate Aug<31>2005
15:23 Oct 25, 2007
entitled‘‘Impact-Resistant Lenses:
Questions and Answers’’ to the Division
of Small Manufacturers, International,
and Consumer Assistance (HFZ–220),
Center for Devices and Radiological
Health, Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850.
Send one self-addressed adhesive label
to assist that office in processing your
request, or fax your request to 240–276–
3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this draft guidance 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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: John
Stigi, Center for Devices and
Radiological Health (HFZ–220), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 240–276–
3150.
Jkt 214001
I. Background
Eyeglasses and sunglasses are medical
devices and are subject to device
regulations, including § 801.410 (21 CFR
801.410). This draft guidance document
revises the original guidance document
entitled ‘‘Impact-Resistant Lenses:
Questions and Answers’’ (FDA 87–
4002), issued September 1987. This
draft guidance document also contains
detailed and updated discussions of the
following: (1) Lens blanks; (2) semifinished, finished, and plano lenses; and
(3) import entry inspections.
To reduce the number of eye injuries,
eyeglasses and sunglasses must be fitted
with impact-resistant lenses capable of
withstanding the impact test described
under § 801.410(d)(2). This draft
guidance answers questions for
manufacturers, importers, and testing
laboratories on such topics as test
procedures, lens testing apparatus,
record maintenance, and exemptions to
testing.
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘ImpactResistant Lenses: Questions and
Answers,’’ you may either send an email request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 240–
276–3151 to receive a hard copy. Please
use the document number (23) to
identify the guidance you are
requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
II. Significance of Guidance
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 801.109 have
been approved under OMB Control No.
0910–0485; the collections of
information in 21 CFR 807.87 have been
approved under OMB Control No. 0910–
0120; and the collections of information
in 21 CFR part 820 have been approved
under OMB Control No. 0910–0073.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on impact-resistant lenses. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
PO 00000
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Fmt 4703
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E:\FR\FM\26OCN1.SGM
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60863
Federal Register / Vol. 72, No. 207 / Friday, October 26, 2007 / Notices
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.
Dated: October 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21122 Filed 10–25–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; the Multi-Ethnic
Study of Atherosclerosis (MESA) Event
Surveillance
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on August 21, 2007, pages
46640–46641, and allowed 60 days for
public comment. No comments were
received. 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: The MultiEthnic Study of Atherosclerosis (MESA)
Event Surveillance. Type of Information
Collection Request: Renewal (OMB No.
0925–0493). Need and Use of
Information Collection: This project
identifies and quantifies factors
associated with the presence and
progression of subclinical
cardiovascular disease (CVD)—that is,
atherosclerosis and other forms of CVD
that have not produced signs and
symptoms. The findings provide
important information on subclinical
CVD in individuals of different ethnic
backgrounds and provide information
for studies on new interventions to
prevent CVD. The aspects of the study
that concern direct participant
evaluation received a clinical exemption
from OMB clearance (CE–99–11–08) in
April 2000. OMB clearance is being
sought for the contact of physicians and
participant proxies to obtain
information about clinical CVD events
that participants experience during the
follow-up period. Frequency of
Response: The participants will be
contacted annually. Affected Public:
Individuals or households; Businesses
or other for profit; Small businesses or
organizations. Type of Respondents:
Individuals or households; physicians.
The annual reporting burden is as
follows: Estimated Number of
Respondents: 550; Estimated Number of
Responses per Respondent: 1.0; Average
Burden Hours Per Response: .2; and
Estimated Total Annual Burden Hours
Requested: 36.7. The annualized cost to
respondents is estimated at $5,595,
assuming respondents time at the rate of
$18.65 per hour and physician time at
the rate of $75 per hour. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
ESTIMATES OF HOUR BURDEN
Number of
respondents
Type of respondent
Frequency of
response
Average time
per response
(hours)
Annual hour
burden
250
300
1
1
0.20
0.20
16.7
20
Total ........................................................................................................
rmajette on PROD1PC64 with NOTICES
Physicians ......................................................................................................
Proxies ...........................................................................................................
550
1
0.20
36.7
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
VerDate Aug<31>2005
15:23 Oct 25, 2007
Jkt 214001
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr. Jean
Olson, Epidemiology Branch, Division
of Prevention and Population Sciences,
NHLBI, NIH, II Rockledge Centre, 6701
Rockledge Drive, Suite 10018, MSC #
7936, Bethesda, MD, 20892–7936, or
call 301–435–0397 (non-toll-free
number), or e-mail your request,
including your address to:
OlsonJ@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
received within 30-days of the date of
this publication.
Dated: October 16, 2007.
Mike Lauer,
Director, Division of Prevention and
Population Sciences, NHLBI, National
Institutes of Health.
Dated: October 18, 2007.
Suzanne Freeman,
OMB Clearance Officer, NHLBI, National
Institutes of Health.
[FR Doc. E7–21103 Filed 10–25–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
E:\FR\FM\26OCN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Notices]
[Pages 60862-60863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21122]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0364]
Draft Guidance for Industry and Food and Drug Administration
Staff; Impact-Resistant Lenses: Questions and Answers; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Impact-Resistant Lenses:
Questions and Answers.'' This draft guidance document answers
manufacturer, importer, and consumer questions on impact-resistant
lenses, including questions on test procedures, lens testing apparatus,
record maintenance, and exemptions to testing.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by January 24, 2008.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled``Impact-Resistant Lenses: Questions and Answers'' to
the Division of Small Manufacturers, International, and Consumer
Assistance (HFZ-220), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to 240-276-3151. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning this draft guidance 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. Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: John Stigi, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-3150.
SUPPLEMENTARY INFORMATION:
I. Background
Eyeglasses and sunglasses are medical devices and are subject to
device regulations, including Sec. 801.410 (21 CFR 801.410). This
draft guidance document revises the original guidance document entitled
``Impact-Resistant Lenses: Questions and Answers'' (FDA 87-4002),
issued September 1987. This draft guidance document also contains
detailed and updated discussions of the following: (1) Lens blanks; (2)
semi-finished, finished, and plano lenses; and (3) import entry
inspections.
To reduce the number of eye injuries, eyeglasses and sunglasses
must be fitted with impact-resistant lenses capable of withstanding the
impact test described under Sec. 801.410(d)(2). This draft guidance
answers questions for manufacturers, importers, and testing
laboratories on such topics as test procedures, lens testing apparatus,
record maintenance, and exemptions to testing.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on impact-
resistant lenses. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Impact-Resistant Lenses:
Questions and Answers,'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number (23) to identify the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 801.109 have been approved under
OMB Control No. 0910-0485; the collections of information in 21 CFR
807.87 have been approved under OMB Control No. 0910-0120; and the
collections of information in 21 CFR part 820 have been approved under
OMB Control No. 0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy.
[[Page 60863]]
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.
Dated: October 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21122 Filed 10-25-07; 8:45 am]
BILLING CODE 4160-01-S
