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, 59072 [05-20305]

Download as PDF 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 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\11OCN1.SGM 11OCN1

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: 05-20305]


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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.

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SUMMARY: 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 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.

    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
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