Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee; Amendment of Notice, 55784 [E7-19332]

Download as PDF 55784 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Notices unapproved hydrocodone products based on FDA’s exercise of enforcement discretion as set forth in this notice. FDA also will not exercise its enforcement discretion with respect to continued manufacturing or shipping of any combination drug product that contains a drug subject to an earlier deadline for the exercise of agency enforcement discretion.7 Drug manufacturers and distributors should be aware that the agency is exercising its enforcement discretion as described previously only in regard to unapproved drug products containing hydrocodone that are marketed under an NDC number listed with the agency on the effective date of this notice. Unapproved drug products containing hydrocodone that are not currently marketed, or that are currently marketed but are not listed with the agency on the effective date of this notice, must, as of the effective date of this notice, have approved applications prior to their introduction or delivery for introduction into interstate commerce. Moreover, submission of an application does not excuse timely compliance with this notice. C. Discontinued Products mstockstill on PROD1PC66 with NOTICES 7For example, if a person is marketing an unapproved product containing both hydrocodone bitartrate and timed-release guaifenesin on or after August 27, 2007, then under the notice FDA issued May 29, 2007 (72 FR 29517), that person is subject to immediate enforcement; FDA will not extend the exercise of its enforcement discretion to the later dates set out in this notice. 18:31 Sep 28, 2007 Dated: September 25, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–19340 Filed 9–28–07; 8:45 am] BILLING CODE 4160–01–S Some firms may have previously discontinued the manufacturing or distribution of products covered by this notice without removing them from the listing of their products under section 510(j) of the act. Other firms may discontinue manufacturing or marketing listed products in response to this notice. Firms that wish to notify the agency of product discontinuation should send a letter, signed by the firm’s chief executive officer, fully identifying the discontinued product(s), including the product NDC number(s), and stating that the product(s) has (have) been discontinued. The letter should be sent to Jennifer Devine (see ADDRESSES) with a copy to the district director of the firm’s FDA district office. Firms should also update the listing of their product(s) under section 510(j) of the act to reflect discontinuation of unapproved hydrocodone products. FDA plans to rely on its existing records, the results of a subsequent inspection, or other available information when we evaluate whether to initiate enforcement action. VerDate Aug<31>2005 D. Reformulated Products In addition, FDA cautions firms against reformulating their products into unapproved new drugs without hydrocodone that are marketed under the same name or substantially the same name (including a new name that contains the old name) in anticipation of an enforcement action based on this notice. In the Marketed Unapproved Drugs CPG, FDA stated that it intends to give higher priority to enforcement actions involving unapproved drugs that are reformulated to evade an anticipated FDA enforcement action. In addition, reformulated products marketed under a name previously identified with a different active ingredient, or combination of active ingredients, have the potential to confuse healthcare practitioners and harm patients. This notice is issued under sections 502 and 505 of the act (21 U.S.C. 352) and under authority delegated to the Deputy Commissioner for Policy under section 1410.10 of the FDA Staff Manual Guide. Jkt 214001 or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), codes 3014512541 and 8732310001. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2007, FDA announced that a joint meeting of Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee would be held on October 18 and 19, 2007. On page 46091, in the third column, the third sentence of the Procedure portion of the document is changed to read as follows: Procedure: Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 10:30 a.m. on October 19, 2007. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: September 23, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–19332 Filed 9–28–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Food and Drug Administration National Cancer Institute; Notice of Closed Meeting [Docket No. 2007P–0074] Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric 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 a joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. This meeting was announced in the Federal Register of August 16, 2007 (72 FR 46091). The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Darrell Lyons, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301–827– 6776, e-mail: darrell.lyons@fda.hhs.gov, PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors for Clinical Sciences and Epidemiology National Cancer Institute. The meetings will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Cancer Institute, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors for Clinical Sciences and Epidemiology National Cancer Institute. Date: November 5, 2007. Time: 9 a.m. to 2 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 72, Number 189 (Monday, October 1, 2007)]
[Notices]
[Page 55784]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007P-0074]


Joint Meeting of the Nonprescription Drugs Advisory Committee and 
the Pediatric Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of a joint meeting of the Nonprescription Drugs 
Advisory Committee and the Pediatric Advisory Committee. This meeting 
was announced in the Federal Register of August 16, 2007 (72 FR 46091). 
The amendment is being made to reflect a change in the Procedure 
portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Darrell Lyons, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5630 
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: 
darrell.lyons@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), codes 
3014512541 and 8732310001. Please call the Information Line for up-to-
date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2007, 
FDA announced that a joint meeting of Nonprescription Drugs Advisory 
Committee and the Pediatric Advisory Committee would be held on October 
18 and 19, 2007. On page 46091, in the third column, the third sentence 
of the Procedure portion of the document is changed to read as follows:
    Procedure: Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 10:30 a.m. on October 19, 2007.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: September 23, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-19332 Filed 9-28-07; 8:45 am]
BILLING CODE 4160-01-S

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