Agency Information Collection Activities: Proposed Collection; Comment Request, 2058-2059 [E6-209]
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Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices
and met with stakeholders in December
2002 to seek their input.
The guidance was initiated in
response to industry’s request for a
formal dispute resolution process to
resolve differences related to scientific
and technical issues that arise between
investigators and pharmaceutical
manufacturers during FDA inspections.
In addition to encouraging
manufacturers to use currently available
dispute resolution processes, the
guidance describes a formal two-tiered
dispute resolution process that provides
a mechanism for requesting review and
decision on issues that arise during
inspections.
On September 5, 2003 (68 FR 52777),
the FDA announced the availability of
the draft version of this guidance. The
public comment period closed on March
5, 2004. A number of comments were
received, which the agency considered
carefully as it finalized the guidance
and made appropriate changes. The
agency conducted a pilot program with
industry for a 12-month period. During
that time, the agency received one Tier
1 request for dispute resolution and it
was resolved. In addition, FDA met with
representatives from industry trade
associations in September 2004, near
the end of the pilot period, to discuss
the draft guidance and receive input.
Most of the changes to the guidance
were made to clarify statements in the
draft guidance. The following changes
in the final guidance are noteworthy: (1)
The time period for manufacturers to
ask for clarification of a disputed
scientific or technical issue was
extended from 10 to 30 days; (2) if a
request for formal dispute resolution
reaches the agency’s Dispute Resolution
Panel and is considered appropriate for
review, the panel will schedule a
meeting to discuss the issue within 90
days of the request instead of the
indefinite time period indicated in the
draft guidance; (3) the guidance directs
manufacturers to the Center for Devices
and Radiological Health for disputes
involving combination products when
medical device components are the
focus of the dispute, but clarifies that
disputes solely involving medical
devices are outside the scope of this
guidance; and (4) the guidance clarifies
that, during the dispute resolution
process, a manufacturer may include
relevant information that was not
presented during the inspection, if FDA
determines that a reasonable
explanation was given on why the
information was not presented during
the inspection.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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15:02 Jan 11, 2006
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The guidance represents the agency’s
current thinking on formal dispute
resolution: scientific and technical
issues related to pharmaceutical CGMP.
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 statutes
and regulations.
II. 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.
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.
III. The Paperwork Reduction Act of
1995
This guidance contains information
collection provisions that 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 collection of information in
this guidance was approved under OMB
control number 0910–0563.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
the following https://www.fda.gov/cder/
guidance/index.htm or https://
www.fda.gov/ohrms/dockets/
default.htm or https://www.fda.gov/cber/
guidelines.htm or https://www.fda.gov/
cvm/guidance/guidance.html.
Dated: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–233 Filed 1–11–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Migrant
Health; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
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Fmt 4703
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Name: National Advisory Council on
Migrant Health.
Dates and Times: January 30, 2006, 9 a.m.
to 5 p.m. January 31, 2006, 9 a.m. to 5 p.m.
Place: 5600 Fishers Lane, Conference
Room C, 3rd Floor, Rockville, Maryland
20857.
Status: The meeting will be open to the
public.
Agenda: The agenda includes an overview
of the Council’s general business activities.
The Council will also develop
recommendations to the Secretary of Health
and Human Services. Finally, the Council
will hear presentations from experts on
farmworker issues, including the status of
farmworker health at the local and national
level.
Agenda items are subject to change as
priorities indicate.
For Further Information Contact: Anyone
requiring information regarding the Council
should contact Gladys Cate, Office of
Minority and Special Populations, staff
support to the National Advisory Council on
Migrant Health, Bureau of Primary Health
Care, Health Resources and Services
Administration, 5600 Fishers Lane,
Rockville, Maryland 20857, Telephone (301)
594–0367.
Dated: January 5, 2006.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–171 Filed 1–11–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
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
of information; (c) ways to enhance the
quality, utility, and clarity of the
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12JAN1
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Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices
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.
Proposed Project: Screening, Brief
Intervention, Brief Treatment and
Referral to Treatment (SBIRT) CrossSite Evaluation—New
SAMHSA’s Center for Substance
Abuse Treatment (CSAT) is conducting
a cross-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, BI, BT
and referrals for persons at risk for
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
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.
TOTAL BURDEN HOURS FOR THE CROSS-SITE PATIENT SURVEY
Number of
respondents
Instrument/activity
Number of
responses per
respondent
Average
burden per
response
Cross-Site Patient Survey:
Baseline Data Collection ........................................................................
6-Month Follow-up Data Collection (80% of baseline) ...........................
Cross-Site Practitioner Survey ...............................................................
10,500
8,400
270
1
1
1
.25
.25
.25
Total .................................................................................................
19,170
........................
........................
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, 1 Choke Cherry Road,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: January 4, 2006.
Anna Marsh,
Director, Office of Program Services.
[FR Doc. E6–209 Filed 1–11–06; 8:45 am]
BILLING CODE 4162–20–P
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on a proposed extension of a
currently approved information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning
reimbursement of claims submitted for
fighting fires on Federal property.
The
collection of information is necessary in
order to reimburse fire services for
claims submitted for fighting fires on
property that is under jurisdiction of the
United States. Section II of the Federal
Fire Prevention and Control Act of 1974,
implemented under 44 CFR part 151,
provides that each fire service that
engages in the fighting of a fire on
property which is under the jurisdiction
of the United States and who has a
mutual aid agreement in effect between
claimant and the 1 Federal Emergency
Management Agency (FEMA) for the
property upon which the fire occurred,
may file a claim with FEMA for the
amount of direct expense and direct
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: Notice and request for
comments.
erjones on PROD1PC68 with NOTICES
AGENCY:
SUMMARY: The Federal Emergency
Management Agency, as part of its
1 The Reimbursement for Cost of Fighting Fire on
Federal Property program is currently being
transferred to the newly created Preparedness
Directorate of the Department of Homeland
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Security. During this transition FEMA, also part of
the Department of Homeland Security, will
continue to support this program as the new
Directorate stands up. Ultimately this data
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Total burden
hours per
collection
2,625
2,100
67.5
4,793
losses incurred by such fire services as
a result of fighting fires.
Collection of Information
Title: Reimbursement for Cost of
Fighting Fire on Federal Property.
Type of Information Collection:
Extension of a currently approved
collection.
OMB Number: 1660–0014.
Abstract: The Federal Emergency
Management Agency (FEMA) Director;
the Administrator of the United States
Fire Administration (USFA); and the
United States Treasury will use the
information to ensure proper
expenditure of Federal funds. Once a
claim is received, a copy of FEMA
determination and the claim is
forwarded to the Treasury Department.
The Treasury Department will pay for
fire services or its parent jurisdiction for
any moneys in the treasury subject to
reimbursement, to the Federal
department or agency under whose
jurisdiction the fire occurred.
Affected Public: Business or Other
For-Profit, Not For-Profit Institutions,
and State, Local or Tribal Government.
Estimated Total Annual Burden
Hours:
collection will be transferred to the Preparedness
Directorate.
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]]>Agencies
[Federal Register Volume 71, Number 8 (Thursday, January 12, 2006)]
[Notices]
[Pages 2058-2059]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper 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 of information; (c) ways to enhance the quality,
utility, and clarity of the
[[Page 2059]]
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.
Proposed Project: Screening, Brief Intervention, Brief Treatment and
Referral to Treatment (SBIRT) Cross-Site Evaluation--New
SAMHSA's Center for Substance Abuse Treatment (CSAT) is conducting
a cross-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,
BI, BT and referrals for persons at risk for 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 six-month follow-
up primarily via computer-assisted telephone interviewing (CATI). A
second survey 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.
Total Burden Hours for the Cross-Site Patient Survey
----------------------------------------------------------------------------------------------------------------
Number of Average Total burden
Instrument/activity Number of responses per burden per hours per
respondents respondent response collection
----------------------------------------------------------------------------------------------------------------
Cross-Site Patient Survey:
Baseline Data Collection................... 10,500 1 .25 2,625
6-Month Follow-up Data Collection (80% of 8,400 1 .25 2,100
baseline).................................
Cross-Site Practitioner Survey............. 270 1 .25 67.5
-----------------
Total.................................. 19,170 .............. .............. 4,793
----------------------------------------------------------------------------------------------------------------
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, 1 Choke Cherry Road, Rockville, MD 20857. Written comments
should be received within 60 days of this notice.
Dated: January 4, 2006.
Anna Marsh,
Director, Office of Program Services.
[FR Doc. E6-209 Filed 1-11-06; 8:45 am]
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