National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting, 42646 [E6-12046]
Download as PDF
<![CDATA[
42646
Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices
announcing such classification. Because
of the timeframes established by section
513(f)(2) of the act, FDA has
determined, under § 10.115(g)(2) (21
CFR 10.115(g)(2)), that it is not feasible
to allow for public participation before
issuing this guidance as a final guidance
document. Thus, FDA is issuing this
guidance document as a level 1
guidance document that is immediately
in effect. FDA will consider any
comments that are received in response
to this notice to determine whether to
amend the guidance document.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidance represents the agency’s current
thinking on fecal calprotectin
immunological test systems. 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.
rwilkins on PROD1PC63 with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. To receive ‘‘Class II Special
Controls Guidance Document: Fecal
Calprotectin Immunological Test
Systems,’’ 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 1599 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.
VerDate Aug<31>2005
16:46 Jul 26, 2006
Jkt 208001
IV. Paperwork Reduction Act of 1995
This 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 part 807, subpart E, have been
approved under OMB control number
0910–0120, the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073, and the collections
of information in 21 CFR part 809 have
been approved under OMB control
number 0910–0485.
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 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.
Dated: July 19, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–11974 Filed 7–26–06; 8:45 am]
BILLING CODE 4160–01–S
Open: September 18, 2006, 9 a.m. to 3 p.m.
Agenda: Psychoactive Drugs and Type 2
Diabetes.
Place: National Institutes of Health, 9000
Rockville Pike, Building 45, Conference
Rooms E1/E2.
Contact Person: Sanford A. Garfield, PhD,
Senior Advisor, Biometrics and Behavioral
Science, National Institute of Diabetes and
Digestive and Kidney Diseases, National
Institutes of Health, PHS, DHHS, 6707
Democracy Blvd, Room 685, Bethesda, MD
20892, 301–594–8803,
Garfields@extra.niddk.nih.gov.
Information is also available on the
Institute’s/Center’s Web site: https://
www.niddk.nih.gov/federal/dmicc.htm,
where an agenda and any additional
information for the meeting will be posted
when available. For logistics and updated
information not available on the Web site,
contact Maria Smith, The Scientific
Consulting Group, Inc., contractor for the
DMICC, at msmith@scgcorp.com.
Please note: In the interest of security, NIH
has instituted stringent procedures for
entrance into the building by nongovernment employees. Persons without a
government I.D. will need to show a photo
I.D. and sign in at the security desk upon
entering the building. Visitors may be
required to pass through a metal detector and
have bags, backpacks, or purses inspected or
x-rayed as they enter NIH buildings. For
more information about the new security
measures at NIH, please visit the Web site at
https://www.nih.gov/about/
visitorsecurity.htm.
Dated: July 20, 2006.
Sanford A. Garfield,
Senior Advisor, National Institute of Diabetes
and Digestive and Kidney Diseases, National
Institutes of Health.
[FR Doc. E6–12046 Filed 7–26–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meeting
Pursuant to section 429 [285c–3] of
the Public Health Service Act (Pub. L.
95–158), notice is hereby given of a
meeting of the statutory Diabetes
Mellitus Interagency Coordinating
Committee.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Diabetes Mellitus
Interagency Coordinating Committee.
Date: September 18, 2006.
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: Screening, Brief
Intervention, Brief Treatment and
Referral to Treatment (SBIRT) CrossSite Evaluation—New
SAMHSA’s Center for Substance
Abuse Treatment is conducting a cross-
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 71, Number 144 (Thursday, July 27, 2006)]
[Notices]
[Page 42646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Meeting
Pursuant to section 429 [285c-3] of the Public Health Service Act
(Pub. L. 95-158), notice is hereby given of a meeting of the statutory
Diabetes Mellitus Interagency Coordinating Committee.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting.
Name of Committee: Diabetes Mellitus Interagency Coordinating
Committee.
Date: September 18, 2006.
Open: September 18, 2006, 9 a.m. to 3 p.m.
Agenda: Psychoactive Drugs and Type 2 Diabetes.
Place: National Institutes of Health, 9000 Rockville Pike,
Building 45, Conference Rooms E1/E2.
Contact Person: Sanford A. Garfield, PhD, Senior Advisor,
Biometrics and Behavioral Science, National Institute of Diabetes
and Digestive and Kidney Diseases, National Institutes of Health,
PHS, DHHS, 6707 Democracy Blvd, Room 685, Bethesda, MD 20892, 301-
594-8803, Garfields@extra.niddk.nih.gov.
Information is also available on the Institute's/Center's Web
site: https://www.niddk.nih.gov/federal/dmicc.htm, where an agenda
and any additional information for the meeting will be posted when
available. For logistics and updated information not available on
the Web site, contact Maria Smith, The Scientific Consulting Group,
Inc., contractor for the DMICC, at msmith@scgcorp.com.
Please note: In the interest of security, NIH has instituted
stringent procedures for entrance into the building by non-
government employees. Persons without a government I.D. will need to
show a photo I.D. and sign in at the security desk upon entering the
building. Visitors may be required to pass through a metal detector
and have bags, backpacks, or purses inspected or x-rayed as they
enter NIH buildings. For more information about the new security
measures at NIH, please visit the Web site at https://www.nih.gov/
about/visitorsecurity.htm.
Dated: July 20, 2006.
Sanford A. Garfield,
Senior Advisor, National Institute of Diabetes and Digestive and Kidney
Diseases, National Institutes of Health.
[FR Doc. E6-12046 Filed 7-26-06; 8:45 am]
BILLING CODE 4140-01-P
