Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h and 2567, 59072 [05-20306]
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59072
Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices
To do so, a public education and
awareness campaign will be launched to
bring about changes in beliefs and social
norms among target audiences
(consumers: women aged 40–60,
healthcare practitioners: nurse
practitioners and physician assistants)
that CFS is a diagnosable and treatable
physical illness.
Although considerable research will
be done to ensure that campaign
themes, messages, and materials are
effective, there is no way to test the
impact of the campaign on the target
audience other than to conduct baseline
and follow-up surveys. These surveys
will measure not only the level of
awareness created by the campaign, but
will measure change in key knowledge,
attitudes and beliefs about CFS among
the target audiences. There is no cost to
respondents other than their time.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
responses
per respondent
Response
burden per
respondent
(in hours)
Total annual
burden
(in hours)
1
1
1
1
1
1
10/60
10/60
10/60
10/60
10/60
10/60
67
67
33
33
33
33
....................
....................
266
Number of
respondents
Respondents
Instrument
Consumers (Women, 40–60 years of age)
Consumers (Women, 40–60 years of age)
Physician Assistants ..................................
Physician Assistants ..................................
Nurse Practitioners ....................................
Nurse Practitioners ....................................
Pre-program survey .................................
Post-program survey ...............................
Pre-program survey .................................
Post-program survey ...............................
Pre-program survey .................................
Post-program survey ...............................
400
400
200
200
200
200
Total ...................................................
..................................................................
....................
Dated: October 4, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–20323 Filed 10–7–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0526]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Fast Track Drug
Development Programs—Designation,
Development, and Application Review
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
16:40 Oct 07, 2005
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20305 Filed 10–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry: Fast Track Drug
Development Programs—Designation,
Development, and Application Review’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 7, 2005 (70 FR
33177), the agency announced that the
proposed information collection had
been submitted to OMB for review and
SUMMARY:
VerDate Aug<31>2005
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0389. The
approval expires on August 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Jkt 208001
[Docket No. 2005N–0083]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
General Licensing Provisions:
Biologics License Application,
Changes to an Approved Application,
Labeling, Revocation and Suspension,
and Forms FDA 356h and 2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
to an Approved Application, Labeling,
Revocation and Suspension, and Forms
FDA 356h and 2567’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
In the
Federal Register of July 21, 2005 (70 FR
42068), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0338. The
approval expires on September 30,
2008. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20306 Filed 10–7–05; 8:45 am]
BILLING CODE 4160–01–S
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘General Licensing Provisions:
Biologics License Application, Changes
PO 00000
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]]>Agencies
[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Notices]
[Page 59072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0083]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension, and Forms FDA 356h and 2567
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension, and Forms FDA 356h and 2567'' has
been approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 21, 2005 (70
FR 42068), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0338.
The approval expires on September 30, 2008. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.fda.gov/ohrms/dockets.
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20306 Filed 10-7-05; 8:45 am]
BILLING CODE 4160-01-S
