Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice, 54730 [2014-21780]

Download as PDF 54730 Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Notices believes were discontinued prior to November 2010, were listed in the notice. TABLE 1—PROPOXYPHENE DRUG PRODUCT APPLICATIONS FOR WHICH FDA PROPOSED TO WITHDRAW APPROVAL Application No. Drug Applicant or holder ANDA 083544 .... Kesso-Gesic (propoxyphene hydrochloride (HCl)) Capsules, 65 milligrams (mg). Propoxyphene HCl Capsules, 65 mg ...................................... Compound 65 (aspirin, caffeine, and propoxyphene HCl) Capsules, 389 mg/32.4 mg/65 mg. MK Laboratories Inc., 424 Grasmere Ave., Fairfield, CT 06430. Whiteworth Towne Paulsen Inc. Alra Labs, 3850 Clearview Ct., Gurnee, IL 60031. ANDA 084551 .... ANDA 084553 .... In its March 10, 2014, notice of opportunity for a hearing, CDER provided these ANDA holders an opportunity to request a hearing to show why approval of the ANDAs should not be withdrawn. No timely request for a hearing on this matter was received following publication of the notice in the Federal Register. Therefore, under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs, approval of the applications listed in table 1 and all amendments and supplements thereto is withdrawn (see DATES). Introduction or delivery for introduction of these products into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 331(d))). Dated: September 5, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21729 Filed 9–11–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of April 25, 2014 (79 FR tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:58 Sep 11, 2014 Jkt 232001 22995). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Submission for OMB Review; 30-Day Comment Request Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA–NCI) Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, email: PDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. In the Federal Register of April 25, 2014, FDA announced that a meeting of the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would be held on October 16, 2014. On page 22996, in the first column, the Agenda portion of the document is changed to read as follows: Agenda: The committees will discuss safety data from observational studies and a meta-analysis of randomized controlled clinical trials that have been conducted since the original signal of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate tablets, NDA 21928, Pfizer, Inc.) emerged. The committees will also discuss whether any action needs to be taken with regard to how this risk is described in product labeling. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. SUPPLEMENTARY INFORMATION: Dated: September 9, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21780 Filed 9–11–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 National Institutes of Health Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 8, 2014, Vol. 79, No. 89, page 26439 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. DATES: Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Bradford W. Hesse, Ph.D., Health Communication and Informatics Research Branch, 9609 Medical Center SUMMARY: E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Page 54730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21780]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Joint Meeting of the Psychopharmacologic Drugs Advisory Committee 
and the Drug Safety and Risk Management Advisory Committee; Amendment 
of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Joint Meeting of the 
Psychopharmacologic Drugs Advisory Committee and the Drug Safety and 
Risk Management Advisory Committee. This meeting was announced in the 
Federal Register of April 25, 2014 (79 FR 22995). The amendment is 
being made to reflect a change in the Agenda portion of the document. 
There are no other changes.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: PDAC@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area). Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 25, 2014, 
FDA announced that a meeting of the Joint Meeting of the 
Psychopharmacologic Drugs Advisory Committee and the Drug Safety and 
Risk Management Advisory Committee would be held on October 16, 2014. 
On page 22996, in the first column, the Agenda portion of the document 
is changed to read as follows:
    Agenda: The committees will discuss safety data from observational 
studies and a meta-analysis of randomized controlled clinical trials 
that have been conducted since the original signal of serious 
neuropsychiatric adverse events with CHANTIX (varenicline tartrate 
tablets, NDA 21928, Pfizer, Inc.) emerged. The committees will also 
discuss whether any action needs to be taken with regard to how this 
risk is described in product labeling.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21780 Filed 9-11-14; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.