Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): CDC Public Health Research: Health Protection Research Initiative Graduate Training Program Grant, Request for Applications (RFA) CD07-001, 42645 [E6-12015]
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42645
Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondents
Number of
respondents
Form
Avg. burden/
response
(in hours)
Total burden
(hours)
Health and QOL questionnaire Final ...............................................................
3000
2
20/60
2000
Total ..........................................................................................................
........................
........................
........................
2184
Dated: July 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–12025 Filed 7–26–06; 8:45 am]
BILLING CODE 4163–18–P
Dated: July 20, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–12015 Filed 7–26–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
[Docket No. 2006D–0275]
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
rwilkins on PROD1PC63 with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): CDC Public
Health Research: Health Protection
Research Initiative Graduate Training
Program Grant, Request for
Applications (RFA) CD07–001
HHS.
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): CDC Public Health Research:
Health Protection Research Initiative
Graduate Training Program Grant, Request
for Applications (RFA) CD07–001.
Time and Date: 12 p.m.–4 p.m., September
14, 2006 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to RFA CD07–001, ‘‘CDC Public
Health Research: Health Protection Research
Initiative Graduate Training Program Grant.’’
Contact Person For More Information:
Christine Morrison, PhD., Scientific Review
Administrator, Office of Extramural
Research, CDC, 1600 Clifton Road, NE.,
Mailstop D72, Atlanta, GA 30333, Telephone
404.639.3098.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
VerDate Aug<31>2005
16:46 Jul 26, 2006
Jkt 208001
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Fecal Calprotectin Immunological Test
Systems; Availability
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Class II Special Controls Guidance
Document: Fecal Calprotectin
Immunological Test Systems.’’ This
guidance document describes a means
by which fecal calprotectin
immunological test systems may comply
with the requirement of special controls
for class II devices. Elsewhere in this
issue of the Federal Register, FDA is
publishing a final rule to classify fecal
calprotectin immunological test systems
into class II (special controls). This
guidance document is immediately in
effect as the special control for fecal
calprotectin immunological test
systems, but it remains subject to
comment in accordance with the
agency’s good guidance practices
(GGPs).
Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Fecal Calprotectin,
Immunological Test Systems’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance
DATES:
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed 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 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 https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Deborah Moore, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0493.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
classifying fecal calprotectin
immunological test systems into class II
(special controls) under section 513(f)(2)
of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360c(f)(2)). This
notice announces the guidance
document that will serve as the special
control for fecal calprotectin
immunological test systems.
Section 513(f)(2) of the act provides
that any person who submits a
premarket notification under section
510(k) of the act (21 U.S.C. 360(k)) for
a device that has not previously been
classified may, within 30 days after
receiving an order classifying the device
in class III under section 513(f)(1) of the
act, request FDA to classify the device
under the criteria set forth in section
513(a)(1) of the act. FDA shall, within
60 days of receiving such a request,
classify the device by written order.
This classification shall be the initial
classification of the device. Within 30
days after the issuance of an order
classifying the device, FDA must
publish a notice in the Federal Register
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 71, Number 144 (Thursday, July 27, 2006)]
[Notices]
[Page 42645]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12015]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): CDC Public Health Research: Health Protection
Research Initiative Graduate Training Program Grant, Request for
Applications (RFA) CD07-001
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the following meeting:
Name: Disease, Disability, and Injury Prevention and Control
Special Emphasis Panel (SEP): CDC Public Health Research: Health
Protection Research Initiative Graduate Training Program Grant,
Request for Applications (RFA) CD07-001.
Time and Date: 12 p.m.-4 p.m., September 14, 2006 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the public in accordance
with provisions set forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director, Management Analysis
and Services Office, CDC, pursuant to Public Law 92-463.
Matters To Be Discussed: The meeting will include the review,
discussion, and evaluation of applications received in response to
RFA CD07-001, ``CDC Public Health Research: Health Protection
Research Initiative Graduate Training Program Grant.''
Contact Person For More Information: Christine Morrison, PhD.,
Scientific Review Administrator, Office of Extramural Research, CDC,
1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone
404.639.3098.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities, for both CDC and the Agency for Toxic Substances and
Disease Registry.
Dated: July 20, 2006.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E6-12015 Filed 7-26-06; 8:45 am]
BILLING CODE 4163-18-P
