Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Continuous Marketing Applications: Pilot-Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act, 60677 [E7-21056]

Download as PDF Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices Submission of Nominations for the Evaluation Set 22 Proposed Substances: Today’s notice also invites voluntary public nominations for substances not listed in this notice. Nominations are most useful if they include the nominator, including full name, title, affiliation, email address, and telephone number. ATSDR will evaluate all data and information associated with nominated substances and will determine the final list of substances that will be chosen for toxicological profile development. Substances will be chosen according to ATSDR’s specific guidelines for selection, found in the Selection Criteria announced in the Federal Register on May 7th, 1993 (87 FR 27288). Please submit nominations by one of the following methods: • E-mail: jxt1@cdc.gov. • Fax: 770.488.4178. • Mail: CDR Jessilynn Taylor, 1600 Clifton Rd, NE., MS F32, Atlanta, GA, 30333. Please ensure that your comments are submitted within the specified nomination period. Nominations received after the closing date will be marked as late and may be considered only if time permits. Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (‘‘Lookback’’)’’ 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 the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. SUPPLEMENTARY INFORMATION: In the Federal Register of August 24, 2007 (72 FR 48766), 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 0910–0610. The approval expires on October 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: October 19, 2007. Ken Rose, Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E7–21018 Filed 10–24–07; 8:45 am] Dated: October 19, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–21055 Filed 10–24–07; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S Food and Drug Administration Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Continuous Marketing Applications: Pilot— Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act [Docket No. 2006N–0278] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (‘‘Lookback’’) mstockstill on PROD1PC66 with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘CGMP for Blood and Blood VerDate Aug<31>2005 17:26 Oct 24, 2007 Jkt 214001 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘ Guidance for Industry on Continuous Marketing Applications: Pilot— Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act‘‘ has been approved by the PO 00000 Frm 00061 Fmt 4703 Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4816. SUPPLEMENTARY INFORMATION: In the Federal Register of May 21, 2007 (72 FR 28495), 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 0910–0518. The approval expires on September 30, 2010. A copy of the supporting statement for this information collection is available on the Internet at https:// www.fda.gov/ohrms/dockets. Dated: October 19, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–21056 Filed 10–24–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 1999N–2337 (formerly Docket No. 99N–2337)] 60677 Sfmt 4703 [Docket No. 2007N-0390] User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Request for Notification of Participation and Number of Advertisements for Review AGENCY: Food and Drug Administration, HHS. Notice; request for notification of participation. ACTION: SUMMARY: The Food and Drug Administration (FDA) is issuing this notice to explain the new direct-toconsumer (DTC) user fee program (DTC user fee program) established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and, as required by the new law, to ask companies to notify FDA within 30 calendar days if they intend to participate in the DTC user fee program during fiscal year (FY) 2008 and, if they do plan to participate, to identify the number of DTC television advertisements for prescription drug and biological products they plan to E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Notices]
[Page 60677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0278]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Continuous 
Marketing Applications: Pilot--Scientific Feedback and Interactions 
During Development of Fast Track Products Under the Prescription Drug 
User Fee Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled `` Guidance for Industry on 
Continuous Marketing Applications: Pilot--Scientific Feedback and 
Interactions During Development of Fast Track Products Under the 
Prescription Drug User Fee Act`` has been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4816.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 21, 2007 (72 
FR 28495), 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 0910-0518. 
The approval expires on September 30, 2010. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.fda.gov/ohrms/dockets.

    Dated: October 19, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21056 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S
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