Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing, 54729 [2014-21728]

Download as PDF Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Notices 54729 DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food and Drug Administration [Docket No. FDA–2013–N–0485] [Docket No. FDA–2013–N–1422] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Allegations of Regulatory Misconduct Associated With Medical Devices Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eye Tracking Study of Direct-toConsumer Prescription Drug Advertisement Viewing [Docket No. FDA–2014–N–0199] AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: Food and Drug Administration, HHS. Notice. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: On May 27, 2014, the Agency submitted a proposed collection of information entitled ‘‘Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices’’ 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 0910–0769. The approval expires on August 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: September 5, 2014. Leslie Kux, Assistant Commissioner for Policy. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: Dated: September 8, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21769 Filed 9–11–14; 8:45 am] [FR Doc. 2014–21728 Filed 9–11–14; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4164–01–P VerDate Mar<15>2010 17:58 Sep 11, 2014 Jkt 232001 The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Eye Tracking Study of Direct-toConsumer Prescription Drug Advertisement Viewing’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@fda.hhs.gov. On June 30, 2014, the Agency submitted a proposed collection of information entitled ‘‘Eye Tracking Study of Directto-Consumer Prescription Drug Advertisement Viewing’’ 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 0910–0772. The approval expires on August 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of three abbreviated new drug applications (ANDAs) for products containing propoxyphene. The basis for the withdrawals is that the products are no longer shown to be safe because propoxyphene puts patients at risk of potentially serious and even fatal heart rhythm abnormalities. The holders of these ANDAs have waived their opportunity for a hearing. DATES: Effective September 12, 2014. FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6254, Silver Spring, MD 20993–0002, 301–796–3601. SUPPLEMENTARY INFORMATION: On November 18, 2010, after receiving clinical data and other information showing that propoxyphene puts patients at risk of potentially serious and even fatal heart rhythm abnormalities, FDA asked manufacturers of then marketed branded and generic propoxyphene drug products to voluntarily withdraw the products from the U.S. market. In a notice published in the Federal Register of March 10, 2014 (79 FR 13308), FDA withdrew approval of 8 new drug applications (NDAs) and 46 ANDAs for propoxyphene drug products from multiple sources whose application holders agreed in writing to waive their opportunity for a hearing and permit FDA to withdraw approval of the applications. In a separate notice published in the Federal Register of March 10, 2014 (79 FR 13310), FDA’s Center for Drug Evaluation and Research (CDER) notified the holders of 3 other approved ANDAs for propoxyphene drug products of their opportunity to request a hearing on CDER’s proposal to issue an order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of 3 ANDAs for propoxyphene drug products. The following products, all of which FDA SUMMARY: E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Page 54729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1422]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Eye Tracking Study of Direct-to-
Consumer Prescription Drug Advertisement Viewing

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 ``Eye Tracking Study of Direct-to-
Consumer Prescription Drug Advertisement Viewing'' has been approved by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On June 30, 2014, the Agency submitted a 
proposed collection of information entitled ``Eye Tracking Study of 
Direct-to-Consumer Prescription Drug Advertisement Viewing'' 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 0910-0772. The approval expires on August 31, 2017. A 
copy of the supporting statement for this information collection is 
available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: September 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21728 Filed 9-11-14; 8:45 am]
BILLING CODE 4164-01-P
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