30-Day FR Notice

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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.

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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
http://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at http://
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.

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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: http://
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
http://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.

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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-

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42647

Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices
site external evaluation of the impact of
programs of screening, brief
intervention (BI), brief treatment (BT)
and referral to treatment on patients
presenting at various health care
delivery units with a continuum of
severity of substance use. CSAT’s SBIRT
program is a cooperative agreement
grant program designed to help six
States and one Tribal Council expand
the continuum of care available for
substance misuse and use disorders.
The program includes screening, Brief
Intervention, Brief Treatment and
Referrals (BI, BT) for persons at risk for

will be administered to practitioners
who are delivering SBIRT services using
CAPI. The patient survey is composed
of questions on substance use behaviors
and other outcome measures such as
productivity, absenteeism, health status,
arrests and accidents. The practitioner
survey is designed to evaluate the
implementation of proposed SBIRT
models by measuring their penetration
and practitioners’ willingness to adopt.
Furthermore, the survey will document
moderating factors related to
practitioner and health care delivery
unit characteristics.

dependence on alcohol or drugs. The
primary purpose of the evaluation is to
study the extent to which the modified
models of SBIRT being implemented by
the grantees expand the continuum of
care available for treatment of substance
use disorders.
A survey will be used to collect data
from patients at the participating
grantee health care delivery units at
baseline using a computer-assisted
personal interview (CAPI) and at a sixmonth follow-up primarily via
computer-assisted telephone
interviewing (CATI). A second survey

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response

Total burden
hours per
collection

Patient Survey:
Baseline Data Collection ..........................................................................
6-Month Follow-up Data ...........................................................................
Practitioner Survey ...................................................................................

3,600
2,880
261

1
1
1

.42
.47
.40

........................
1,512
1,354
104

Total ...................................................................................................

3,861

........................

........................

2,970

Written comments and
recommendations concerning the
proposed information collection should
be sent by August 28, 2006 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–6974.
Dated: July 20, 2006.
Anna Marsh,
Director, Office of Program Services.
[FR Doc. E6–12028 Filed 7–26–06; 8:45 am]
BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Request for Comment From the Field
on the Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Addiction Technology
Transfer Center (ATTC) Program
Substance Abuse and Mental
Health Services Administration, HHS.
SUMMARY: This notice is to request
comments from interested stakeholders
in the substance use disorders treatment
field regarding SAMHSA’s ATTC
Program. SAMHSA will be issuing a
Request for Applications (RFA) for a
AGENCY:

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Number of
responses per
respondent

Number of
respondents

Instrument/activity

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new round of competitive cooperative
agreement awards under the ATTC
program in Federal fiscal year (FFY)
2007. To assist SAMHSA in developing
the RFA, SAMHSA is seeking input
from stakeholders and interested parties
on a number of issues relating to these
cooperative agreements.
Program Title: Addiction Technology
Transfer Centers (ATTC) Program.
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.243.
Authority: Section 5001(d)(5) of the Public
Health Service Act, as amended.
FOR FURTHER INFORMATION CONTACT:

Catherine D. Nugent, SAMHSA/CSAT/
DSI, 1 Choke Cherry Road, Room 5–
1079, Rockville, MD 20857, phone: 240–
276–1577, e-mail:
cathy.nugent@samhsa.hhs.gov.
Introduction
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is committed to building
resilience and facilitating recovery for
people with or at risk for substance use
and mental disorders. SAMHSA
collaborates with the States, national
associations, local community-based
and faith-based organizations, and
public and private sector providers to
implement initiatives in its priority
areas, including development of the
workforce serving individuals needing
treatment and recovery for substance
use disorders. The Center for Substance
Abuse Treatment (CSAT) supports
training and technology transfer

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activities to promote the adoption of
evidence-based practices in substance
use disorders treatment and, more
broadly, to promote workforce
development in the addiction treatment
field. CSAT’s Addiction Technology
Transfer Centers (ATTCs), funded by
CSAT since 1993, are a major
component of SAMHSA/CSAT’s
workforce development efforts.
The ATTC Network is dedicated to
identifying and advancing opportunities
for improving addiction treatment. The
vision of the ATTCs is to unify science,
education and services to transform the
lives of individuals and families
affected by alcohol and other drug
addition.
Serving the 50 States, the District of
Columbia, Puerto Rico, the U.S. Virgin
Islands and the Pacific Islands, the
ATTC Network operates as 14
individual Regional Centers and a
National Office. At the regional level,
individual Centers focus primarily on
meeting the unique needs in their areas
while also supporting national
initiatives. The National Office leads the
Network in implementing national
initiatives and concurrently supports
and promotes individual regional
efforts.
The current ATTC program is funded
through cooperative agreements initially
awarded in 2001 and 2002. These
cooperative agreements will end in FFY
2007. SAMHSA/CSAT will be issuing a
new funding announcement to recompete the ATTCs in FY 2007. To
assist CSAT in designing the

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