Federal Register / Vol. 77, No. 142 / Tuesday, July 24, 2012 / Notices 43337

TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1—Continued

Number of Number of disclosures Total annual Average burden Citation respondents per disclosures per disclosure Total hours respondent

21 CFR 101.105 ...... 12 2 24 0 .5 12 Section 403(w)(1) of the FD&C Act ...... 12 2 24 1 24 Guidance document entitled ‘‘Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration’’ ...... 12 1 12 1 12

Total ...... 186 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA’s estimate of the number of The draft guidance also refers to DEPARTMENT OF HEALTH AND respondents in table 1 is based on the previously approved collections of HUMAN SERVICES number of regulatory submissions information found in FDA regulations. submitted to TTB for beers that do not The collections of information in Food and Drug Administration meet the definition of a ‘‘malt beverage’’ §§ 101.3, 101.4, 101.5, 101.9, 101.22, [Docket Nos. FDA–1975–N–0336 (Formerly under the FAA Act. Based on its records and 101.105 have been approved under 75N–0184), FDA–1975–N–0355 (Formerly of submissions received from OMB control number 0910–0381. 75N–0185), FDA–1976–N–0272 (Formerly manufacturers of such products, TTB 76N–0056), FDA–1976–N–0344 (Formerly estimates the number of respondents to II. References 76N–0057), FDA–1978–N–0701 (Formerly be 12 and the number of disclosures 78N–0070), FDA–1979–N–0224 (Formerly annually to be 24. Thus, FDA adopts The following references have been 79N–0169), FDA–1983–N–0297 (Formerly TTB’s estimate of 12 respondents, and placed on display in the Division of 83N–0030), and FDA–1988–N–0004 an annual number of disclosures per Dockets Management (HFA–305), Food (Formerly 88N–0242); DESI 597, 1626, 3265, 10837, 12283, and 50213, and respondent of 2, in table 1 of this and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, Hydrocortisone Acetate and Pramoxine document. Hydrochloride] FDA’s estimate of the average burden and may be seen by interested persons per disclosure for each regulation are between 9 a.m. and 4 p.m., Monday Drugs for Human Use; Drug Efficacy based on FDA’s experience with food through Friday. (FDA has verified the Study Implementation; Certain labeling under the Agency’s Web site addresses, but we are not Prescription Drugs Offered for Various jurisdiction. The estimated average responsible for any subsequent changes Indications; Opportunity To Affirm burden per disclosure for §§ 101.3, to the Web sites after this document Outstanding Hearing Request 101.4, 101.5, 101.9, 101.22, and 101.105 publishes in the Federal Register.) in table 1 are equal to, and based upon, ACTION: Notice. the estimated average burden per 1. Memorandum of Understanding disclosure approved by OMB in OMB 225–88–2000 between FDA and Bureau SUMMARY: The Food and Drug control number 0910–0381. FDA further of Alcohol, Tobacco and Firearms, Administration (FDA) is offering an estimates that the labeling burden of available at http://www.fda.gov/ opportunity to affirm outstanding section 403(w)(1) of the FD&C Act, AboutFDA/PartnershipsCollaborations/ hearing requests pertaining to several which specifies requirements for the MemorandaofUnderstandingMOUs/ dockets. FDA will assume that declaration of food allergens, will be 1 DomesticMOUs/ucm116370.htm. companies with outstanding hearing requests that do not respond to this hour based upon the similarity of the 2. TTB Ruling 2008–3 dated July 7, notice are no longer interested in requirements to that of § 101.4. Finally, 2008, available at http://www.ttb.gov/ pursuing their requests, and will deem FDA estimates that a respondent will rulings/2008-3.pdf. spend 1 hour reading the guidance the requests withdrawn. document. Dated: July 16, 2012. DATES: Effective Date: This notice is Thus, FDA estimates that 12 Leslie Kux, effective August 23, 2012. respondents will each label 2 products Assistant Commissioner for Policy. Hearing Requests: Hearing requests annually, for a total of 24 labels. FDA [FR Doc. 2012–18028 Filed 7–23–12; 8:45 am] must be affirmed by notifying FDA by estimates that the manufacturers will August 23, 2012. Hearing requests not BILLING CODE 4160–01–P spend 7.25 hours (0.5 hours + 1 hour + affirmed within that timeframe will be 0.25 hour + 4 hours + 0.5 hour + 1 hour deemed withdrawn. = 7.25 hours) on each label to comply ADDRESSES: Requests to affirm or with FDA’s labeling regulations and the withdraw outstanding hearing requests, requirements of section 403(w)(1) of the as well as all other communications in FD&C Act, for a total of 174 hours (24 response to this notice, should be labels × 7.25 hours = 174 hours). In identified with the appropriate docket addition, 12 respondents will each number, and directed to Pamela Lee, spend 1 hour reading the guidance Office of Unapproved Drugs and document, for a total of 12 hours. Thus, Labeling Compliance, Center for Drug FDA estimates the total hour burden of Evaluation and Research, Food and the proposed collection of information Drug Administration, 10903 New to be 186 hours (174 hours + 12 hours Hampshire Ave., Bldg. 51, rm. 5173, = 186 hours). Silver Spring, MD 20993–0002.

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FOR FURTHER INFORMATION CONTACT: DESI covered the approximately 3,400 Drug Evaluation and Research is Pamela Lee, Center for Drug Evaluation products specifically reviewed by the reviewing proceedings that remain open and Research, Food and Drug NAS/NRC, as well as the even larger under DESI. According to FDA’s Administration, 10903 New Hampshire number of IRS products that entered the records, the dockets discussed in this Ave., Bldg. 51, rm. 5173, Silver Spring, market without FDA approval. document contain pending hearing MD 20993–0002, 301–796–3297, email: All drugs covered by the DESI review requests. [email protected]. are ‘‘new drugs’’ under the FD&C Act. This Federal Register notice identifies SUPPLEMENTARY INFORMATION: The Food If FDA’s final DESI determination the products that are the subjects of and Drug Administration (FDA) is classifies a drug product as lacking hearing requests to the extent possible offering an opportunity to affirm substantial evidence of effectiveness for based on the information contained in outstanding hearing requests pertaining one or more indications, that drug the hearing requests. In some cases, the to FDA Docket Nos. FDA–1975–N–0336 product and those IRS to it may no companies requesting hearings (formerly 75N–0184) (DESI 597); FDA– longer be marketed for the indications identified the product that was the 1976–N–0272 (formerly 76N–0056), and are subject to enforcement action as subject of the hearing request by name. unapproved new drugs. If FDA’s final In other cases, the company simply FDA–1976–N–0344 (formerly 76N– DESI determination classifies the drug identified the subject of its hearing 0057), and FDA–1978–N–0701 (formerly product as effective for one or more of request as a product that is IRS to one 78N–0070) (DESI 1626); FDA–1975–N– its labeled indications, the drug can be of the products reviewed under DESI. In 0355 (formerly 75N–0185) (DESI 3265); marketed for those indications, yet other cases, there is no information FDA–1975–N–0336 (formerly 75N– provided it is the subject of an provided by the requester about the 0184) (DESI 10837); FDA–1979–N–0224 application approved for safety and product that is the subject of its hearing (formerly 79N–0169) (DESI 12283); effectiveness. Sponsors of drug products request. FDA–1983–N–0297 (formerly 83N– that have been found to be effective for In cases where FDA was able to obtain 0030) (DESI 50213); and FDA–1988–N– one or more indications through the current contact information for a 0004 (formerly 88N–0242). DESI process may rely on FDA’s company (or its successor-in-interest) or I. Background effectiveness determinations, but its representative, FDA sent letters typically must update their labeling to directly to the companies (or their When initially enacted in 1938, the conform to the indications found to be successors-in-interest) and/or their Federal Food, Drug, and Cosmetic Act effective by FDA and to include any representatives requesting that (the FD&C Act) required that ‘‘new additional safety information required outstanding hearing requests be drugs’’ (see 21 U.S.C. 321(p)) be by FDA. Those drug products with withdrawn or affirmed within a approved for safety by FDA before they NDAs approved before 1962 for safety specified timeframe. In some cases, could legally be sold in interstate therefore require approved supplements however, FDA was unable to find commerce. To this end, the FD&C Act to their original applications if found to current contact information for the made it the sponsor’s responsibility, be effective under DESI; IRS drug companies that requested hearings. before marketing a new drug, to submit products require an approved NDA or Because many of the products that are a new drug application (NDA) to FDA abbreviated new drug application the subjects of these hearing requests to prove that its drug was safe. Between (ANDA), as appropriate. Furthermore, may no longer be marketed and some of 1938 and 1962, if a drug obtained labeling for drug products classified as the companies that requested hearings approval, FDA considered drugs that effective may contain only those may no longer be in business, FDA is were identical, related, or similar (IRS) indications for which the review found seeking to determine whether there is (see (21 CFR 310.6(b)(1)) to the the product effective unless the firm continued interest in pursuing these approved drug to be ‘‘covered’’ by that marketing the product has received an outstanding hearing requests. It should approval, and allowed those IRS drugs approval for the additional be noted that the discussion of DESI to be marketed without independent indication(s). dockets does not provide a approval. comprehensive historical record of each In 1962, Congress amended the FD&C II. Outstanding Hearing Requests docket and, therefore, will not identify Act to require that new drugs be proven Pertaining to Docket Nos. FDA–1975– every request that had been previously effective for their labeled indications, as N–0336 (Formerly 75N–0184) (DESI addressed. well as safe, to obtain FDA approval. 597); FDA–1976–N–0272 (Formerly Through this Federal Register notice, This amendment also necessitated that 76N–0056), FDA–1976–N–0344 FDA seeks to have any company with an FDA conduct a retrospective evaluation (Formerly 76N–0057), and FDA–1978– outstanding hearing request covered by of the effectiveness of the drug products N–0701 (Formerly 78N–0070) (DESI this notice that has not already that FDA had approved as safe between 1626); FDA–1975–N–0355 (Formerly responded to a direct communication 1938 and 1962. FDA contracted with the 75N–0185) (DESI 3265); FDA–1975–N– from FDA either withdraw or affirm its National Academy of Sciences/National 0336 (Formerly 75N–0184) (DESI hearing request. FDA will assume that Research Council (NAS/NRC) to make 10837); FDA–1979–N–0224 (Formerly companies with outstanding hearing an initial evaluation of the effectiveness 79N–0169) (DESI 12283); FDA–1983–N– requests that do not respond to this of over 3,400 products that had been 0297 (Formerly 83N–0030) (DESI notice are no longer in business and/or approved only for safety between 1938 50213); and FDA–1988–N–0004 do not have a continuing interest in the and 1962. The NAS/NRC reports for (Formerly 88N–0242) hearings, and FDA will deem their these drug products were submitted to In 2006, FDA announced a new drug requests withdrawn. FDA in the late 1960s and early 1970s. safety initiative to address unapproved To withdraw an outstanding hearing The Agency reviewed and reevaluated drugs currently being marketed in the request, a company (or its successor-in- the reports and published its findings in United States, and to facilitate a rational interest) or its representative should Federal Register notices. FDA’s process to bring all such unapproved send a letter stating its intention to do administrative implementation of the drugs into the approval process. As part so to Pamela Lee (see ADDRESSES). The NAS/NRC reports was called the Drug of the Unapproved Drugs Initiative, the letter should include the docket number Efficacy Study Implementation (DESI). Office of Compliance of the Center for of the proceeding, as well as the name

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and National Drug Code (NDC) number 902 Carnegie Center, Suite 360, requesting that they withdraw or affirm of the product that is the subject of the Princeton, NJ 08540), regarding Levsin their outstanding hearing requests under hearing request. with Phenobarbital Tablets (ANDA 86– this docket within 30 days: Pfizer, Inc.; To affirm an outstanding hearing 640); Lemmon Co. (now part of Teva B.F. Ascher & Co., Inc.; Glaxo request, a company (or its successor-in- Pharmaceuticals, 1090 Horsham Rd., SmithKline; Meda Pharmaceuticals, interest) or its representative should P.O. Box 1090, North Wales, PA 19454– Inc.; Ferndale Pharma Group, Inc.; send a letter stating its intention to do 1090), regarding Belladonna Alkaloids Acura Pharmaceutical Co.; Kremers- so to Pamela Lee (see ADDRESSES). The and Phenobarbital Tablets (ANDA 86– Urban Pharmaceuticals, Inc.; Teva letter should include the docket number 591); McNeil Pharmaceutical (now part Pharmaceuticals; Ortho-McNeil-Janssen of the proceeding, as well as the name of Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Actavis US; and NDC number of the product that is Pharmaceuticals, Inc., 1125 Trenton- Abbott Laboratories; Impax the subject of the hearing request. Harbourton Rd., P.O. Box 200, Laboratories, Inc.; Sandoz, Inc.; Letters affirming outstanding hearing Titusville, NJ 08568), regarding Butibel AstraZeneca Pharmaceuticals LP; West- requests must be postmarked or emailed Tablets and Butibel Elixir (ANDA 86– ward Pharmaceutical Corp.; and Sanofi- by the date specified in this notice (see 664); National Pharmaceutical Aventis U.S. DATES). Only currently outstanding Manufacturing Co. (now part of Actavis On May 24, 2011, Actavis US hearing requests may be affirmed; this US, 60 Columbia Rd., Bldg. B, withdrew the hearing request filed by notice does not provide a new Morristown, NJ 07960), regarding National Pharmaceutical Manufacturing opportunity to request a hearing under Barophen Elixir (ANDA 86–546) and Co. On May 26, 2011, Teva any of these dockets. Butabar Belladonna Elixir (ANDA 86– Pharmaceuticals and Impax Laboratories, Inc., withdrew the hearing A. Certain Drug Products Containing an 561); Purepac Pharmaceutical (now part requests filed by Lemmon Co. and Anticholinergic in Combination With a of Actavis US, 60 Columbia Rd., Bldg. Richlyn Laboratories, Inc., respectively. Barbituate; Docket No. FDA–1975–N– B, Morristown, NJ 07960), regarding On June 2, 2011, Ferndale Pharma 0336 (Formerly 75N–0184) (DESI 597) Belladonna Alkaloids with Phenobarbital Tablets and Elixir; Reid- Group, Inc., withdrew its hearing Under Docket No. FDA–1975–N–0336 Provident Laboratories, Inc. (now part of request. On June 3, 2011, AstraZeneca (formerly 75N–0184), FDA determined Abbott Laboratories, 100 Abbott Park Pharmaceuticals, LP, withdrew the that certain drug products containing an Rd., Abbott Park, IL 60064–3500), hearing request filed by Stuart anticholinergic in combination with a regarding Spalix Elixir (ANDA 86–652) Pharmaceuticals. On June 6, 2011, barbiturate lacked substantial evidence and Spalix Tablets (ANDA 86–653); Acura Pharmaceutical Co. withdrew the of effectiveness for various Richlyn Laboratories, Inc. (now part of hearing request filed by Halsey Drug gastrointestinal disorders, and offered Impax Laboratories, Inc., 30831 Co., Inc. On June 7, 2011, Johnson & an opportunity for hearing regarding its Johnson Pharmaceutical Research & conclusion (48 FR 20495, May 6, 1983). Huntwood Ave., Hayward, CA 94544), regarding Bellophen (ANDA 86–687) Development, LLC, responded to the In response to the May 1983 notice, the letter sent to Ortho-McNeil-Janssen following companies filed timely and Spasmolin (ANDA 86–655); Sandoz, Inc., 506 Carnegie Center, Suite Pharmaceuticals, Inc., stating that the hearing requests: A.H. Robins Co. (now rights to Butibel Elixir had been part of Pfizer, Inc., 235 East 42nd St., 400, Princeton, NJ 08540, regarding Belladenal Tablets (ANDA 86–668) and transferred to Carter Wallace in 1982. New York, NY 10017), regarding On June 20, 2011, B.F. Ascher & Co., Belladenal S Tablets (ANDA 87–198); Donnatal Tablets (ANDA 86–676), Inc., withdrew its hearing request. On Stuart Pharmaceuticals, Division of ICI Capsules (ANDA 86–677), and Elixir June 22, 2011, Novartis Pharmaceuticals Americas, Inc. (now part of AstraZeneca (ANDA 86–661); B.F. Ascher & Co., Inc., Corp., the successor-in-interest by Pharmaceuticals LP, 1800 Concord Pike, 15501 W. 109th St., Lenexa, KS 66219, merger to Sandoz, Inc., withdrew P.O. Box 15437, Wilmington, DE 19850– regarding Anaspaz-PB; Bay Laboratories, Sandoz, Inc.’s hearing request. On July 5437), regarding Kinesed Tablets; Vale Inc., 3654 West Jarvis, Skokie, IL 60076, 7, 2011, Meda Pharmaceuticals, Inc., Chemical Co., Inc., 1201 Liberty St., regarding Bay-Ase Elixir (ANDA 86– withdrew the hearing request filed by Allentown, PA 18102, regarding 673); Beecham Laboratories, a Division Carter-Wallace, Inc., as well as the Barbeloid Tablets, Green (NDA 85–532) of Beecham, Inc. (now part of Glaxo hearing request filed by McNeil SmithKline, 200 N 16th St., #1, and Barbeloid Tablets, Yellow (NDA Pharmaceutical for Butibel Tablets and Philadelphia, PA 19102), regarding 86–549); West-ward Pharmaceutical Elixir. On July 27, 2011, Kremers-Urban Hybephen (ANDA 86–573); Carter- Corp., 401 Industrial Way West, Co. withdrew its hearing request. On Wallace, Inc. (now part of Meda Eatontown, NJ 07724–2206, regarding August 11, 2011, GlaxoSmithKline Pharmaceuticals, Inc., 265 Davidson Belladonna Alkaloid with Phenobarbital withdrew the hearing request filed by Ave., Suite 300, Somerset, NJ 08873– Tablets; William P. Poythress & Co., Beecham Laboratories. On August 24, 4120), regarding Barbidonna Tablets Inc., 16 N. 22nd St., P.O. Box 26946, 2011, Abbott Laboratories withdrew the (ANDA 86–589), Barbidonna Elixir Richmond, VA 23261, regarding hearing request filed by Reid-Provident (ANDA 86–590), and Barbidonna No. 2 unidentified products composed of Laboratories, Inc. Tablets (ANDA 87–572); Ferndale atropine sulfate 0.195 milligrams (mg) On July 6, 2011, West-ward Laboratories, Inc. (now part of Ferndale in combination with phenobarbital 16 Pharmaceutical Corp. affirmed its Pharma Group, Inc., 780 W. Eight Mile mg; William Rorer, Inc. (now part of hearing request and PBM Rd., Ferndale, MI 48220), regarding Sanofi-Aventis U.S., 55 Corporate Dr., Pharmaceuticals, Inc., affirmed the Bellkatal Tablets and Pheno-Bella Bridgewater, NJ 08807), regarding hearing request filed by A.H. Robins Tablets; Halsey Drug Co., Inc. (now part Chardonna-2 Tablets (ANDA 86–585); Co., as the asserted successor-in-interest of Acura Pharmaceuticals, Inc., 616 N. and Wharton Laboratories, Inc., 48th to A.H. Robins Co.’s hearing request. A North Court, Suite 120, Palatine, IL Ave., Long Island City, NY 11101, Federal Register notice issued on June 60067), regarding Susano Elixir (ANDA regarding Bellastal Capsules (ANDA 86– 8, 2011 (76 FR 33310), withdrew the 86–587) and Susano Tablets (ANDA 86– 657). approval of 70 NDAs and 97 ANDAs. 588); Kremers-Urban Co. (now part of In May, June, and July 2011, FDA sent This included the withdrawal of the Kremers-Urban Pharmaceuticals, Inc., letters to the following companies approval for Donnatal Capsules and

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withdrawal of the conditional approval proposed withdrawing associated In March and April 2011, FDA sent for the Donnatal Tablets and Elixir. This NDAs, and offered an opportunity for letters to Abbott Laboratories, Actavis withdrawal notice was subsequently hearing regarding its proposal (41 FR US, Mead Johnson Nutrition, and Pfizer, corrected to note that the approval and 15051, April 9, 1976). The group of Inc., requesting that these companies conditional approvals for these products products addressed in the April 1976 withdraw or affirm their outstanding were still in effect, because PBM notice contained more than 2 grains of hearing requests under this docket Pharmaceuticals, Inc., had acquired the xanthine derivative, a barbiturate in within 30 days. rights to the ANDAs and had informed higher strength than the equivalent of On April 25, 2011, Mead Johnson FDA before the withdrawal would have 8 mg of phenobarbital, and/or an Nutrition withdrew the hearing request become effective that it did not want the ingredient not considered as part of the filed by Mead Johnson Laboratories. On ANDAs withdrawn (76 FR 79701, OTC drug review (Docket No. FDA– May 3, 2011, Pfizer, Inc. withdrew the December 22, 2011). 1976–N–0272 (formerly 76N–0056)) hearing request filed by Warner Lambert As of April 1, 2012, Actavis U.S. (with (id.). The holders of the NDAs listed in Co. On May 9, 2011, Actavis US respect to the hearing request filed by the April 1976 notice did not request withdrew the hearing request filed by Purepac Pharmaceutical) and Sanofi- hearings, and those NDAs were National Pharmaceutical Manufacturing Aventis U.S. had not responded to FDA. withdrawn in October 1977 (42 FR Co. On June 21, 2011, Abbott FDA was unable to find current contact 54620, October 7, 1977). However, in Laboratories withdrew the hearing information for Bay Laboratories, Inc.; response to the April 1976 notice, the request filed by Knoll Pharmaceutical Vale Chemical Co., Inc.; William P. following companies filed timely Co. Poythress & Co., Inc.; and Wharton hearing requests: Knoll Pharmaceutical FDA was unable to find current Laboratories, Inc. If any of these Co. (now part of Abbott Laboratories, contact information for William P. companies, or any successor-in-interest, 100 Abbott Park Rd., Abbott Park, IL Poythress & Co. If this company, or its continues to have an interest in 60064–3500), regarding Quadrinal successor-in-interest, continues to have pursuing its hearing request under this Tablets and Suspension, and Mead an interest in pursuing its hearing docket, the companies (or their Johnson Laboratories (now Mead request under this docket, the company successors-in-interest) must affirm their Johnson Nutrition, 4th Floor, 2701 (or its successor-in-interest) must affirm hearing requests in writing by the date Patriot Blvd., Glenview, IL 60026), its hearing request in writing by the date specified in this notice (see DATES). FDA regarding Quibron Plus Capsules and specified in this notice (see DATES). FDA will assume that hearing requests that Elixir. will assume that hearing requests that are not affirmed within that timeframe are not affirmed within that timeframe are no longer being pursued, and will In 1984, FDA amended the April 1976 are no longer being pursued, and will deem them withdrawn. notice to include its analysis of new deem them withdrawn. information regarding combination B. Combination Drugs Containing a products containing a xanthine C. Certain Single Entity Antispasmodic Xanthine Derivative; Docket No. FDA– derivative (49 FR 7454, February 29, Drugs; Docket No. FDA–1975–N–0355 1976–N–0272 (Formerly 76N–0056), 1984). Based on its analysis of the new (Formerly 75N–0185) (DESI 3265) FDA–1976–N–0344 (Formerly 76N– information, FDA concluded that there In 1971, FDA published DESI efficacy 0057), and FDA–1978–N–0701 is a lack of substantial evidence that: findings for single-ingredient (Formerly 78N–0070) (DESI 1626) (1) Each ingredient contributes to the anticholinergic drugs for oral or In 1972, FDA classified certain claimed effect of such combination drug injectable use containing dicyclomine combination drug products containing a products, and (2) the dosage of each HCl and piperidolate HCl, among other xanthine derivative as less than effective component is such that the ingredients (36 FR 11754, June 18, for some labeled indications and combinations are safe and effective for 1971). In a notice published on possibly effective for other labeled a significant patient population (id.). November 11, 1975 (40 FR 52644), FDA indications (37 FR 14895, July 26, 1972). Therefore, FDA proposed in the 1984 determined that the June 18, 1971, As described in a Federal Register notice to withdraw approval of the Federal Register notice should not have notice of February 29, 1984, FDA applications for combination products included drugs containing certain subsequently handled these products in containing a xandine derivative, and specified ingredients, including three groups: (1) Combinations offered an opportunity for hearing dicyclomine HCl and piperidolate HCl, containing more than 2 grains of regarding its proposal. In response to because the drugs containing those xanthine derivative, more than 8 mg of the February 1984 notice, the following ingredients were not anticholinergic phenobarbital, and/or an ingredient not companies filed timely hearing requests: drugs. Also on November 11, 1975, FDA considered as part of the over-the- National Pharmaceutical Manufacturing published a notice of opportunity for counter (OTC) drug review (Docket No. Co. (now part of Actavis US, 60 hearing regarding these drugs (40 FR FDA–1976–N–0272 (formerly 76N– Columbia Rd., Bldg. B, Morristown, NJ 52649). In response to the November 0056)); (2) combinations containing 2 07960), regarding Brondelate Elixir, 1975 notice, the following companies grains or less of a xanthine derivative, Ferdinal Suspension, Guiaphed Elixir, filed timely hearing requests: Carnrick ephedrine, and 8 mg or less of Hydroxyzine Compound Syrup, Laboratories, Inc., 65 Horsehill Rd., phenobarbital (Docket No. FDA–1976– Iophylline Elixir, Isolate Compound Cedar Knolls, NJ 07927, regarding N–0344 (formerly 76N–0057)); and (3) Elixir, and Theofed Suspension and Midrin, and Merrell-National combinations containing theophylline, Liquid; Warner Lambert Co. (now part Laboratories, 110 Amity Rd., Cincinnati, ephedrine, and hydroxyzine of Pfizer, Inc., 235 East 42nd St., New OH 45215, regarding Bentyl Capsules hydrochloride (HCl) (Docket No. FDA– York, NY 10017), regarding Tedral SA; (NDA 7–409), Bentyl Injection (NDA 8– 1978–N–0701 (formerly 78N–0070)) (49 and William P. Poythress & Co., Inc., 16 370), Bentyl Syrup (NDA 7–961), and FR 7454, February 29, 1984). N. 22nd St., P.O. Box 26946, Richmond, Dactil Tablets (NDA 8–907). In 1976, FDA reclassified certain VA 23261, regarding an unidentified In September 2011, FDA sent letters combination preparations containing a product containing a xanthine to counsel for Carnrick Laboratories, xanthine derivative to lacking derivative, ephedrine, and 8 mg or less Inc., which FDA believed operated as a substantial evidence of effectiveness, of phenobarbital. subsidiary of Elan Corporation PLC, and

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to Sanofi-Aventis U.S., which FDA Laboratories, Inc. (now part of Teva chlorthalidone because of safety believes to be the successor-in-interest Pharmaceuticals, 1090 Horsham Rd., concerns at that dosage level (id. at to Merrell-National Laboratories. In P.O. Box 1090, North Wales, PA 19454– 54126). The 1979 notice proposed to September 2011, Carnrick Laboratories, 1090), regarding Meprohex 200 (ANDA withdraw approval of the 100-mg Inc.’s former counsel informed FDA that 86–674), Meprohex 400 (ANDA 86– strength and offered an opportunity for it did not represent Carnrick 658), and chlordinium capsules (ANDA hearing regarding its proposal. In Laboratories, Inc., or Elan Corporation 86–667). response to the 1979 notice, the PLC with respect to the hearing request FDA sent letters to Genentech, Inc., in following companies filed timely under DESI 3265. In October 2011, FDA November 2010, and to Sandoz, Inc., hearing requests: Generics International sent a letter to Sun Pharmaceutical and counsel of record for Premo Division of Apotex, Inc., 2400 North Industries, Inc., believing it to be the Pharmaceutical Laboratories, Inc., in Commerce Pkwy., suite 400, Weston, FL successor-in-interest to Carnrick January 2011, requesting that these 33326, regarding Chlorthalidone, and Laboratories, Inc.’s hearing request. On companies withdraw or affirm their USV Pharmaceutical Corp. (now part of November 3, 2011, a representative from outstanding hearing requests under this Sanofi-Aventis U.S., 55 Corporate Dr., Sun Pharmaceutical Industries, Inc., docket within 30 days. At the time, FDA Bridgewater, NJ 08807), regarding verbally informed FDA that it was was unable to find a current address for Hygroton (NDA 12–283). withdrawing the hearing request filed Premo Pharmaceutical Laboratories, FDA sent letters to Sanofi-Aventis by Carnrick Laboratories, Inc., and Inc., and did not know that the U.S. and Apotex, Inc., in May 2011 and stated they would be submitting their company is part of Teva July 2011, respectively, requesting that withdrawal of the hearing request in Pharmaceuticals. the companies withdraw or affirm their writing. On February 4, 2011, Genentech, Inc., outstanding hearing requests under this As of April 1, 2012, Sanofi-Aventis informed FDA that it was no longer docket within 30 days. U.S. has not responded to FDA. If this interested in pursuing the hearing On August 12, 2011, Sanofi-Aventis company, or the successor-in-interest, request filed by Roche Laboratories, but U.S. withdrew the outstanding hearing continues to have an interest in noted that it had sold the rights of the request filed by USV Pharmaceutical pursuing the hearing request filed by product that was the subject of the Corp. As of April 1, 2012, Apotex, Inc., Merrell-National Laboratories under this hearing request to Valeant had not responded to FDA. If this docket, the company (or its successor- Pharmaceuticals International, Inc. On company, or its successor-in-interest, in-interest) must affirm the hearing February 28, 2011, Sandoz, Inc., continues to have an interest in request in writing by the date specified withdrew the hearing request filed by pursuing its hearing request under this in this notice (see DATES). FDA will Cord Laboratories. On March 15, 2011, docket, the company (or its successor- assume that hearing requests that are Teva Pharmaceuticals withdrew the in-interest) must affirm its hearing not affirmed within that timeframe are hearing request filed by Premo request in writing by the date specified no longer being pursued, and will deem Pharmaceutical Laboratories, Inc. in this notice (see DATES). FDA will them withdrawn. In March 2011, FDA sent a letter to assume that hearing requests that are Valeant Pharmaceuticals International, not affirmed within that timeframe are D. Certain Anticholinergics/ Inc., requesting that the company no longer being pursued, and will deem Antispasmodics in Combination With a withdraw or affirm the outstanding them withdrawn. Sedative, and Single-Entity hearing request filed by Roche Antispasmodics, in Conventional Laboratories under this docket within F. Chlortetracycline and Tetracycline; Dosage Form; Docket No. FDA–1975–N– 30 days. As of April 1, 2012, Valeant Docket No. FDA–1983–N–0297 0336 (Formerly 75N–0184) (DESI 10837) Pharmaceuticals International, Inc., had (Formerly 83N–0030) (DESI 50213) Through DESI review, FDA not responded to FDA. If this company, Through DESI review, FDA determined that two products, or its successor-in-interest, continues to determined that certain fixed- Pathibamate and Milpath Tablets, both have an interest in pursuing its hearing combination drugs containing containing tridihexethyl chloride and request under this docket, the company antibiotics and sulfonamides lack meprobamate, were possibly effective as (or its successor-in-interest) must affirm substantial evidence of effectiveness (34 adjunctive therapy in peptic ulcer and its hearing request in writing by the date FR 6008, April 2, 1969). The April 1969 in the irritable bowel syndrome, specified in this notice (see DATES). FDA Federal Register notice proposed to functional diarrhea, drug-induced will assume that hearing requests that revoke provisions for certification of diarrhea, ulcerative colitis, urinary are not affirmed within that timeframe these products and offered interested bladder spasm, and urethral spasm (36 are no longer being pursued, and will persons 30 days to submit data FR 11875, June 22, 1971). In 1981, FDA deem them withdrawn. concerning the proposal. Data submitted reclassified these products to lacking in response to the April 1969 notice did substantial evidence of effectiveness, E. Chlorthalidone; Docket No. FDA– not provide substantial evidence of proposed withdrawing associated 1979–N–0224 (Formerly 79N–0169) effectiveness, so FDA amended the NDAs, and offered an opportunity for (DESI 12283) antibiotic regulations on June 30, 1970, hearing regarding its proposal (46 FR In 1979, as part of the DESI review, by revoking provisions for the 3977, January 16, 1981). In response to FDA announced its conclusions certification of these drugs (35 FR the January 1981 notice, the following regarding the effectiveness of 10587, June 30, 1970). The order was to companies filed timely hearing requests: chlorthalidone for the treatment of become effective in 40 days, and Cord Laboratories (now part of Sandoz, hypertension and certain types of edema allowed 30 days for interested persons Inc., 2555 West Midway Blvd., (44 FR 54124, September 18, 1979). to file objections and request a hearing. Broomfield, CO 80020), regarding Specifically, FDA determined that there The time for responding to the June Chlordinium Capsules (ANDA 86–667); was substantial evidence to support the 1970 order was subsequently extended Roche Laboratories (now part of effectiveness of the 25- and 50-mg until August 17, 1970 (35 FR 12653, Genentech, Inc., 1 DNA Way, South San strengths for use in hypertension, but August 8, 1970). Francisco, CA 94080–4990), regarding that there was no longer justification for In response to the June 1970 order, Librax; and Premo Pharmaceutical the 100-mg dosage form of Pfizer, Inc., submitted data regarding its

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affected product, Urobiotic 250 83–213), Pramosone cream (0.5% DEPARTMENT OF HEALTH AND Capsules, and requested a hearing. hydrocortisone acetate) (ANDA 83–778), HUMAN SERVICES Despite the filing of timely objections, Pramosone cream (1.0% hydrocortisone the amendments were inadvertently not acetate) (ANDA 85–368), Pramosone Health Resources and Services stayed, and succeeding codifications of lotion (1.0% hydrocortisone acetate) Administration the antibiotic regulations did not (ANDA 85–979), Pramosone lotion Notice Regarding Section 340B of the explicitly provide for certification of (2.5% hydrocortisone acetate) (ANDA Urobiotic 250 Capsules. However, FDA Public Health Service Act Registration 85–980), Pramosone ointment (1% Period permitted Pfizer, Inc., to continue hydrocortisone acetate), Pramosone distribution of its product pending ointment (2.5% hydrocortisone acetate), AGENCY: Department of Health and resolution of the firm’s hearing request. Pramosone cream (2.5% hydrocortisone Human Services, Health Resources and In July 2010, Pfizer, Inc., voluntarily Services Administration. withdrew its application for Urobiotic acetate), Enzone cream, Zone-A lotion, (see 75 FR 42455, July 21, 2010), but its Zone-A Forte lotion, Zone-A cream, FEP ACTION: Notice. hearing request remains pending. cream, Dibucort cream, and Procto- SUMMARY: The Health Resources and In October 2010, FDA sent Pfizer, Inc., cream HC; and Reed & Carnrick (now Services Administration (HRSA) is a letter requesting that it withdraw or part of Meda Pharmaceuticals, Inc., 265 issuing this notice to inform affirm its outstanding hearing request Davidson Ave., suite 300, Somerset, NH stakeholders of the revised deadlines for under this docket within 30 days. As of 08873–4120), regarding its topical April 1, 2012, Pfizer, Inc., had not aerosol foam hydrocortisone and registration of new covered entities and for adding outpatient facilities and responded to FDA. If Pfizer, Inc. (or its pramoxine HCl products (ANDAs 86– contract pharmacy arrangements to the successor-in-interest), continues to have 195 and 86–457). 340B Drug Pricing Program (340B an interest in pursuing its hearing In November 2010, FDA sent letters to request under this docket, the company Program). Copley Pharmaceutical, Inc.; Ferndale (or its successor-in-interest) must affirm DATES: Effective Date: October 1, 2012. Pharma Group, Inc.; and Meda its hearing request in writing by the date Pharmaceuticals, Inc., requesting that FOR FURTHER INFORMATION CONTACT: CDR specified in this notice (see DATES). FDA these companies (or their successors-in- Krista Pedley, Director, OPA, HSB, will assume that hearing requests that HRSA, 5600 Fishers Lane, Parklawn are not affirmed within that timeframe interest) withdraw or affirm their outstanding hearing requests under this Building, Room 10C–03, Rockville, MD are no longer being pursued, and will 20857, or by telephone at 301–594– docket within 30 days. On January 3, deem them withdrawn. 4353. 2011, counsel for Ferndale Laboratories, G. Hydrocortisone Acetate and Inc., and Meda Pharmaceutical, Inc., SUPPLEMENTARY INFORMATION: Pramoxine HCl; Docket No. FDA–1988– sent a letter affirming the hearing N–0004 (Formerly 88N–0242) I. Background requests made by both companies. Through DESI review, FDA Section 340B(a)(4) of the Public As of April 1, 2012, Copley determined that topical corticosteroids, Health Service Act (PHS) Act (42 U.S.C. Pharmaceutical, Inc., had not responded including hydrocortisone acetate, were 256b) lists the various types of effective for symptomatic relief and to FDA. If this company (or its organizations eligible to participate in adjunctive management of various successor-in-interest) continues to have and purchase discounted drugs under steroid-responsive dermatoses (36 FR an interest in pursuing its hearing the 340B Program. For a complete list of 7982, April 28, 1971). In the mid-1970s, request under this docket, the company eligible entities, visit the OPA Web site FDA approved several products under (or its successor-in-interest) must affirm at http://www.hrsa.gov/ ANDAs listing hydrocortisone acetate as its hearing request in writing by the date opa.introduction.htm. Eligibility for their sole active ingredient. specified in this notice (see DATES). FDA participation in the 340B Program is Subsequently, FDA determined that will assume that hearing requests that limited to the categories of entities these products also contained an are not affirmed within that timeframe specified in this section of the statute. anesthetic active ingredient, pramoxine are no longer being pursued, and will Section 340B(a)(9) of the PHS Act HCl. FDA evaluated the effectiveness of deem them withdrawn. requires the Secretary to notify the fixed-combination and found no This notice is issued under the participating manufacturers of the evidence that the pramoxine HCl Federal Food, Drug, and Cosmetic Act identity of those entities that meet the component contributes an effect to the definition of covered entity under (sections 502 and 505 (21 U.S.C. 352 combination drug (53 FR 25013, July 1, 340B(a)(4). HRSA published final and 355)). 1988). Thus, FDA proposed to withdraw guidelines on the participation of the ANDAs for these products and Dated: July 18, 2012. outpatient facilities in the Federal offered an opportunity for hearing on its Leslie Kux, Register at 59 FR 47884 (Sept. 19, 1994). proposal (id). Assistant Commissioner for Policy. HRSA published final guidelines on the In response to the July 1988 notice, [FR Doc. 2012–18015 Filed 7–23–12; 8:45 am] utilization of Contract Pharmacy the following companies filed timely Arrangements in the Federal Register at hearing requests: Copley BILLING CODE 4160–01–P 75 FR 10272 (March 5, 2010). Pharmaceutical, Inc., 398 West Second St., Boston, MA 02127, regarding a II. Registration Deadlines topical aerosol foam hydrocortisone and This notice replaces all previous 340B pramoxine HCl product (ANDA 89– Program guidance documents 440); Ferndale Laboratories, Inc. (now addressing the deadline and enrollment part of Ferndale Pharma Group, Inc., period for the 340B Program registration 780 W. Eight Mile Rd., Ferndale, MI of new covered entities, addition of 48220), regarding Pramosone lotion outpatient facilities and contract (0.5% hydrocortisone acetate) (ANDA pharmacies, including any individual

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