National Institute of Mental Health; Notice of Meeting, 17966-17967 [E9-9033]
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Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices
follow-up. Barriers to implementing the
follow-up, as well as types of deviation
from the site’s follow-up plan will also
be assessed. Open-ended questions
about what led to deviations from the
site’s follow-up plan will also be
included. In total, it is expected that
counselors will complete the
questionnaire for each of the calls that
were monitored.
(4) Researchers will begin conducting
follow-up interviews with callers
approximately 6 weeks after the initial
call to the center. This follow-up
telephone interview (‘‘MI/SP Caller
Follow-up Interview’’) will be conducted
to collect information on demographic
characteristics, gather caller feedback on
the initial call made to the center,
suicide risk status at the time of and
since the call, current depressive
symptomatology, follow through with
the safety plan and referrals made by the
crisis counselor, and barriers to service.
Taking into account attrition and the
number of callers who do not give
consent, it is expected that the total
number of follow-up interviews
conducted by the research team will not
exceed 885. The MI/SP Caller Initial
Script protects the privacy of callers by
asking the caller how and when they
want to be contacted, and what type of
message (if any) can be left on an
answering machine or with the person
picking up the telephone. The caller
also has the option of not providing
contact information to the crisis center
if he/she prefers to call the evaluation
team back directly. The telephone script
used when the evaluation team contacts
the participant for their follow-up
interview (MI/SP Caller Follow-up
Consent Script, see Attachment H)
includes (1) the fact that the information
collection is sponsored by an agency of
the Federal Government, (2) the purpose
of the information collection and the
uses which will be made of the results,
(3) the voluntary nature of participation,
and (4) the extent to which responses
will be held confidential.
The estimated response burden to
collect this information is as follows
annualized over the requested three year
clearance period is presented below:
TOTAL AND ANNUALIZED AVERAGES: RESPONDENTS, RESPONSES AND HOURS
Number of
respondents
Instrument
Number of
responses per
respondent*
Hours/
response
Response
burden*
National Suicide Prevention Lifeline—Call Monitoring Form ...........................
Crisis Hotline Telephone Initial Script ..............................................................
Crisis Hotline Telephone Consent Script .........................................................
Crisis Hotline Telephone Follow-up Assessment ............................................
MI/SP Silent Monitoring Form ..........................................................................
MI/SP Caller Initial Script .................................................................................
MI/SP Caller Follow-up Consent Script ...........................................................
MI/SP Caller Follow-up Interview ....................................................................
MI/SP Counselor Consent ...............................................................................
MI/SP Counselor Attitudes Questionnaire .......................................................
MI/SP Counselor Follow-up Questionnaire .....................................................
10
365
365
365
10
368
368
295
75
75
175
44
1
1
1
37
1
1
1
1
1
2
.58
.08
.17
.67
.58
.08
.17
.67
.08
.25
.17
249
29
62
245
214
29
63
198
6
19
89
Total ..........................................................................................................
2,471
........................
........................
1,181
* Rounded to the nearest whole number.
Written comments and
recommendations concerning the
proposed information collection should
be sent by May 20, 2009 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: April 13, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–8974 Filed 4–17–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institutes of Health
Criteria for Vaccination Requirements
for U.S. Immigration Purposes
[Correction]
A notice ‘‘Criteria for Vaccination
Requirements for U.S. Immigration
Purposes’’ was published in the Federal
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This notice is corrected as follows: On
page 15986 second column, under
DATES, second sentence should read:
Comments received after May 8, 2009,
will be considered to the extent
possible.
Dated: April 13, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–8981 Filed 4–17–09; 8:45 am]
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National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Interagency Autism Coordinating
Committee.
The meeting will be open to the
public, with attendance limited to space
availability, and will be accessible by
videocast. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
inform the Contact Person listed below
at least 5 business days in advance of
the meeting.
Name of Committee: Interagency Autism
Coordinating Committee (IACC).
Date: May 4, 2009.
Time: 9 a.m. to 4 p.m.
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rmajette on PRODPC74 with NOTICES
Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices
Agenda: To discuss the annual strategic
plan updating process and services and
supports activities.
Place:
In Person: National Institutes of Health,
William H. Natcher Conference Center, 45
Center Drive/Building 45, Conference Rooms
E1/E2, Bethesda Campus, Bethesda, MD
20892.
Videocast: https://videocast.nih.gov.
Contact Person: Ms. Lina Perez, Office of
Autism Research Coordination, Office of the
Director, National Institute of Mental Health,
NIH, 6001 Executive Boulevard, Bethesda,
MD 20892–9669, (301) 443–6040.
IACCpublicinquiries@mail.nih.gov.
Any member of the public interested in
presenting oral comments to the Committee
should notify the Contact Person listed on
this notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations should
submit a letter of intent, a brief description
of the organization represented, and a
written/electronic copy of the oral
presentation in advance of the meeting. Only
one representative of an organization will be
allowed to present oral comments and
presentations will be limited to a maximum
of five minutes. Both printed and electronic
copies are requested following the
presentation for the public record. In
addition, any interested person may submit
written comments to the Committee by
forwarding the statement to the Contact
Person listed on this notice. The statement
should include the name, address, telephone
number and when applicable, the business or
professional affiliation of the interested
person.
NIH has instituted stringent security
procedures for entrance onto the NIH
campus. All visitors must enter through the
NIH Gateway Center. This center combines
visitor parking, non-commercial vehicle
inspection and visitor ID processing, all in
one location. The NIH will process all
visitors in vehicles or as pedestrians. You
will be asked to submit to a vehicle or
personal inspection and will be asked to state
the purpose of your visit. Visitors over 15
years of age must provide a form of
government-issued ID such as a driver’s
license or passport. All visitors should be
prepared to have their personal belongings
inspected and to go through metal detection
inspection.
When driving to NIH, plan some extra time
to get through the security checkpoints. Be
aware that visitor parking lots on the NIH
campus can fill up quickly. The NIH campus
is also accessible via the metro Red Line,
Medical Center Station. The Natcher
Conference Center is a 5-minute walk from
the Medical Center Metro Station.
Additional NIH campus visitor information
is available at: https://www.nih.gov/about/
visitor/index.htm. Information about the
IACC and a registration link for this meeting
are available on the Web site: https://
www.iacc.hhs.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
VerDate Nov<24>2008
15:02 Apr 17, 2009
Jkt 217001
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: April 13, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–9033 Filed 4–17–09; 8:45 am]
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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: Pilot
Lifestyle Interventions for Pregestational
Diabetes or Gestational Diabetes,
Potential Extramural Project, PEP 2009–
R–02
Correction: This notice was published
in the Federal Register on March 25,
2009, Volume 74, Number 56, page
12873. The original notice was
published with an incorrect Potential
Extramural Project number.
Contact Person for More Information:
Linda Shelton, Public Health Analyst,
Coordinating Center for Health and
Information Service, Office of the
Director, CDC, 1600 Clifton Road NE.,
Mailstop E21, Atlanta, GA 30333.
Telephone (404) 498–1194.
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: April 9, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–8947 Filed 4–17–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0143]
Risk Evaluation and Mitigation
Strategies for Certain Opioid Drugs;
Notice of Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice of public meeting;
request for comments.
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17967
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting to obtain input on
developing Risk Evaluation and
Mitigation Strategies (REMS) for certain
opioid drugs. The REMS would be
intended to ensure that the benefits of
these drugs continue to outweigh
certain risks. The agency has long been
concerned about adverse events
associated with this class of drug and
has taken steps in cooperation with drug
manufacturers to address these risks.
We intend to use the agency’s REMS
authority under the Food and Drug
Administration Amendments Act of
2007 (FDAAA) to mitigate the risks of
these drugs. The purpose of the public
meeting is to receive information and
comments on this topic.
DATES: The public meeting will be held
on May 27 and 28, 2009, from 8 a.m. to
5 p.m. Register to attend the meeting by
May 15, 2009. See section III of this
document for information on how to
register or make an oral presentation at
the meeting. Written or electronic
comments will be accepted until June
30, 2009.
ADDRESSES: The public meeting will be
held at the Hilton Washington, DC
North/Gaithersburg Hotel, 620 Perry
Pkwy., Gaithersburg, MD 20877. Submit
written comments 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.regulations.gov. All comments
should be identified with the docket
number found in brackets in the
heading of this document. Transcripts of
the meeting will be available for review
at the Division of Dockets Management
and on the Internet at https://
www.regulations.gov approximately 30
days after the meeting.
FOR FURTHER INFORMATION CONTACT:
Theresa (Terry) Martin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6184,
Silver Spring, MD 20993–0002, 301–
796–3448, FAX: 301–847–8752, or Anne
Henig, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg 51, rm. 6176, Silver Spring,
MD 20993–0002, 301–796–3442, FAX:
301–847–8753, email:
OpioidREMS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDAAA (Public Law 110–85) created
section 505–1 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355–1). Under section 505–1 of the act,
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[Federal Register Volume 74, Number 74 (Monday, April 20, 2009)]
[Notices]
[Pages 17966-17967]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9033]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Pursuant to section 10(a) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
Interagency Autism Coordinating Committee.
The meeting will be open to the public, with attendance limited to
space availability, and will be accessible by videocast. Individuals
who plan to attend and need special assistance, such as sign language
interpretation or other reasonable accommodations, should inform the
Contact Person listed below at least 5 business days in advance of the
meeting.
Name of Committee: Interagency Autism Coordinating Committee
(IACC).
Date: May 4, 2009.
Time: 9 a.m. to 4 p.m.
[[Page 17967]]
Agenda: To discuss the annual strategic plan updating process
and services and supports activities.
Place:
In Person: National Institutes of Health, William H. Natcher
Conference Center, 45 Center Drive/Building 45, Conference Rooms E1/
E2, Bethesda Campus, Bethesda, MD 20892.
Videocast: https://videocast.nih.gov.
Contact Person: Ms. Lina Perez, Office of Autism Research
Coordination, Office of the Director, National Institute of Mental
Health, NIH, 6001 Executive Boulevard, Bethesda, MD 20892-9669,
(301) 443-6040. IACCpublicinquiries@mail.nih.gov.
Any member of the public interested in presenting oral comments to
the Committee should notify the Contact Person listed on this notice
at least 10 days in advance of the meeting. Interested individuals
and representatives of organizations should submit a letter of
intent, a brief description of the organization represented, and a
written/electronic copy of the oral presentation in advance of the
meeting. Only one representative of an organization will be allowed
to present oral comments and presentations will be limited to a
maximum of five minutes. Both printed and electronic copies are
requested following the presentation for the public record. In
addition, any interested person may submit written comments to the
Committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
NIH has instituted stringent security procedures for entrance
onto the NIH campus. All visitors must enter through the NIH Gateway
Center. This center combines visitor parking, non-commercial vehicle
inspection and visitor ID processing, all in one location. The NIH
will process all visitors in vehicles or as pedestrians. You will be
asked to submit to a vehicle or personal inspection and will be
asked to state the purpose of your visit. Visitors over 15 years of
age must provide a form of government-issued ID such as a driver's
license or passport. All visitors should be prepared to have their
personal belongings inspected and to go through metal detection
inspection.
When driving to NIH, plan some extra time to get through the
security checkpoints. Be aware that visitor parking lots on the NIH
campus can fill up quickly. The NIH campus is also accessible via
the metro Red Line, Medical Center Station. The Natcher Conference
Center is a 5-minute walk from the Medical Center Metro Station.
Additional NIH campus visitor information is available at:
https://www.nih.gov/about/visitor/index.htm. Information about the
IACC and a registration link for this meeting are available on the
Web site: https://www.iacc.hhs.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.242,
Mental Health Research Grants; 93.281, Scientist Development Award,
Scientist Development Award for Clinicians, and Research Scientist
Award; 93.282, Mental Health National Research Service Awards for
Research Training, National Institutes of Health, HHS)
Dated: April 13, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-9033 Filed 4-17-09; 8:45 am]
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