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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
Poet knowingly and willfully caused the period of debarment (section SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act services in any capacity to a person that Division of Dockets Management (see debarment of an individual if FDA finds has an approved or pending drug ADDRESSES). All such submissions are to
306(a)(2)(B) of the FD&C Act, that Dr. FD&C Act. The proposal also offered Dr. Management between 9 a.m. and 4 p.m., entered judgment against Dr. Poet for 13 Poet an opportunity to request a date of receipt of the letter in which to Howard Sklamberg,
failure to request a hearing constituted Director, Office of Enforcement, Office of a waiver of the opportunity for a hearing Regulatory Affairs. [FR Doc. 2011–4778 Filed 3–2–11; 8:45 am] U.S.C. 331(k), 333(a)(2), and 352(i)(3). action. Dr. Poet failed to respond within BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
drug product. The factual basis for those debarment (21 CFR part 12). convictions is as follows: During 2003– Food and Drug Administration
II. Findings and Order
[Docket Nos. FDA–1981–N–0077 (formerly
to practice medicine in the State of New 81N–0393), FDA–1981–N–0248 (formerly
Jersey. Dr. Poet owned and operated the Enforcement, Office of Regulatory 81N–0396), FDA–1982–N–0046 (formerly
Affairs, under section 306(a)(2)(B) of the 82N–0095), FDA–1982–N–0264 (formerly
FD&C Act, under authority delegated to 82N–0096), and FDA–1983–N–0137
practice, Dr. Poet injected patients with (formerly 83N–0095); DESI 6514, 11935, and
1410.35), finds that Albert Poet has been 12152]
convicted of a felony under Federal law Drugs for Human Use; Drug Efficacy
for conduct relating to the regulation of Study Implementation; Oral
Prescription Drugs Offered for Relief of
Symptoms of Cough, Cold, or Allergy;
Withdrawal of Hearing Requests; Final
obtain money and property by means of providing services in any capacity to a Resolution of Dockets
drug product application under sections AGENCY: Food and Drug Administration,
505, 512, or 802 of the FD&C Act (21 ACTION: Notice.
newspapers offering BOTOX treatments section 351 of the Public Health Service at his office. Between December 4, 2003, Act (42 U.S.C. 262) (see DATES) (see
SUMMARY: The Food and Drug
sections 306(c)(1)(B) and (c)(2)(A)(ii), 13 orders for a total of 26 vials of TRI– and 201(dd) of the FD&C Act (21 U.S.C. 321(dd))). Any person with an approved pertaining to oral prescription drugs offered for relief of symptoms of cough, cold, or allergy, Docket Nos. FDA–1981– labeled ‘‘For Research Purposes Only, Not for Human Use.’’ Dr. Poet injected many of the approximately 130 patients capacity during Dr. Poet’s debarment, will be subject to civil money penalties unapproved TRI–Toxin between January (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Poet provides services in any capacity to a person with withdrawn. Therefore, shipment in not inform most of his patients receiving an approved or pending drug product the TRI–Toxin injections that they were application during his period of money penalties (section 307(a)(7) of the product that is not the subject of an patients the same price for the cheaper, FD&C Act). In addition, FDA will not VerDate Mar<15>2010 16:47 Mar 02, 2011 Jkt 223001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\03MRN1.SGM 03MRN1 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
unlawful as of the effective date of this DATES: Effective Date: This notice is
marketed under NDA 8–306); Phenergan Pharmaceuticals. In the January 7, 2011, ADDRESSES: All communications in
hearing requests. Requests that were not hydrochloride, marketed under NDA 8– B. Docket FDA–1981–N–0248 (formerly No. FDA–1981–N–0248 (formerly 81N– potassium guaiacolsulfonate, citric acid, 0396) (DESI 6514) were Dimetane FOR FURTHER INFORMATION CONTACT:
marketed under NDA 8–306); Phenergan brompheniramine maleate, Sakineh Walther, Division of New Drugs Expectorant Plain (containing sodium citrate, marketed under NDA 8– (containing codeine phosphate, SUPPLEMENTARY INFORMATION:
potassium guaiacolsulfonate, citric acid, 11–694); and Actifed-C Expectorant I. Background
In a notice published in the Federal
Register of January 7, 2011 (76 FR 1174) 11–265). In a notice published in the
Federal Register of May 25, 1982 (47 FR guaifenesin, marketed under NDA 12–
Federal Register of May 25, 1982, FDA
these products, to remain on the market permitted these drug products, and program had been withdrawn.1 2 Also in beyond the time limit established for those products IRS to these products, to products to lacking substantial evidence limit established for DESI. The notice also reclassified the products to lacking and offered an opportunity for a hearing announced in the Federal Register of
approval of reformulated versions of its products. Accordingly, in the Federal
Register of August 24, 1984 (49 FR
A. Docket No. FDA–1981–N–0077 (formerly 81N–0393) (DESI 6514) pertaining to the old formulations of the withdrawing approval of those portions No. FDA–1981–N–0077 (formerly 81N– In the Federal Register of September
1 For background on the DESI review in general West Jarvis, Skokie, IL 60076, for its IRS that it was withdrawing approval of and the DESI review as it relates to the dockets addressed in this notice, please see the January 7, Actifed-C Expectorant, effective October 2 In the January 7, 2011, notice, FDA stated that with respect to Docket No. FDA–1982–N–0225 (formerly 82N–0078), Chlor-Trimeton Repetabs chlorpheniramine maleate and marketed under NDA 7–638, had been discontinued. FDA notes that 7205 Windsor Blvd., Baltimore, MD NDA 7–638 is currently active; however, products under it are not marketed for indications found VerDate Mar<15>2010 16:47 Mar 02, 2011 Jkt 223001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\03MRN1.SGM 03MRN1 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
hearing requests under this docket filed hearing request under this docket filed by National Pharmaceuticals, Inc., 7205 chlorpheniramine and Expectorant DC, and Pseudodine ‘‘C’’ current contact information for National unable to find current contact Pharmaceuticals. In the January 7, 2011, information for Pioneer hearing request. Its hearing request was to be deemed withdrawn if the company their hearing requests. Requests that contact information for Bay Laboratories did not affirm the request within 30 were not affirmed within 30 days of that D. Docket FDA–1982–N–0264 (formerly E. Docket FDA–1983–N–0137 (formerly No. FDA–1982–N–0264 (formerly 82N– No. FDA–1983–N–0137 (formerly 83N– C. Docket FDA–1982–N–0046 (formerly No. FDA–1982–N–0046 (formerly 82N– maleate, 50 mg of phenylpropanolamine contained 12 mg brompheniramine isopropamide, and was marketed under maleate, 15 mg phenylephrine bromodiphenhydramine hydrochloride, Spansules was reformulated as a controlled-release product containing 12 controlled-release form, and was published in the Federal Register of
per 5 milliliters (mL), and was marketed sulfate, marketed under NDA 5–914). In originally formulated, and those a notice published in the Federal
published in the Federal Register of
Register of May 25, 1982 (47 FR 22604), market beyond the time limit
established for DESI. In the notice, FDA December 23, 1983, notice), FDA that permitted these drug products, and also announced the conditions for those products IRS to these products, to marketing Ornade Spansules, as reformulated, and the products IRS to it, those products IRS to these products, to also reclassified the products to lacking and offered an opportunity for a hearing proposal to withdraw approval of the NDA with respect to the old formulation NDAs for the original formulations of In the Federal Register of May 24,
In the Federal Register of December
12, 1984 (49 FR 48387), FDA announced December 23, 1983, notice, the the old, three-ingredient formulation for reformulate Dimetapp Extentabs to Ornade Spansules, effective January 11, contain 12 mg brompheniramine approved. Accordingly, in the Federal
Register of August 24, 1984, FDA
hearing requests under this docket filed phenylpropanolamine hydrochloride announced it was withdrawing approval by Pioneer Pharmaceuticals, Inc., 209 40th Street, Irvington, NJ 07111, for its company as a generic version of Ornade 1984, respectively. In the December 23, VerDate Mar<15>2010 16:47 Mar 02, 2011 Jkt 223001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\03MRN1.SGM 03MRN1 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
to Sakineh Walther (see ADDRESSES).
of their products under section 510(j) of the FD&C Act to reflect discontinuation Laboratories, Inc. In the January 7, 2011, of unapproved products. FDA plans to Pharmaceutical, Inc., 101 East Main St., opportunity to affirm or withdraw their Little Falls, NJ 07424, for its IRS product hearing requests. Requests that were not information, when it targets violations aware that, after the effective date of this II. Final Resolution of Docket Nos.
Inc., 65 Horse Hill Rd., Cedar Knolls, NJ FDA–1981–N–0077 (formerly 81N–
0393), FDA–1981–N–0248 (formerly
81N–0396), FDA–1982–N–0046
(formerly 82N–0095), FDA–1982–N–264 not the subject of an ongoing DESI
(formerly 82N–0096), and FDA–1983–
N–0137 (formerly 83N–0095)
The time period for responding to the IV. Reformulated Products
January 7, 2011, notice has elapsed, and HC, Ban-Tuss C Expectorant, Tuss-Delay Because no outstanding hearing requests are included in the OTC monograph in were affirmed in response to the January 21 CFR part 341, ‘‘Cold, Cough, Allergy, 7, 2011, notice (or in response to FDA’s previous attempts to contact companies Products for Over-the-Counter Human Use.’’ OTC products that comply with Mayrand Inc., 4 Dundas Circle, P.O. Box N–0077 (formerly 81N–0393), FDA– products IRS to Dimetapp Extentabs and FDA–1982–N–0046 (formerly 82N– Elixir; Pharmaceutical Basics, Inc., 301 approved NDA or ANDA, is unlawful as ingredient or combination of active of the effective date of this notice. This notice is not applicable to OTC products confuse health care practitioners and Edison St., Amityville, NY 11701, for its (21 CFR 310.6(f)). Any person who 502 and 505 of the FD&C Act (21 U.S.C. product is covered by this notice should 352 and 355), and under authority Extentab Tablets; United States Trading and Research (see ADDRESSES).
III. Discontinued Products
Leslie Kux,
Ave. North, Minneapolis, MN 55441, for distribution of products covered by this Acting Assistant Commissioner for Policy. [FR Doc. 2011–4702 Filed 3–2–11; 8:45 am] BILLING CODE 4160–01–P
Cosmetic Act (the FD&C Act) (21 U.S.C. executive officer, fully identifying the South San Francisco, CA 94080; Copley number(s), and stating that the VerDate Mar<15>2010 16:47 Mar 02, 2011 Jkt 223001 PO 00000 Frm 00043 Fmt 4703 Sfmt 9990 E:\FR\FM\03MRN1.SGM 03MRN1

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