Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices 48351
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Annual Frequency 21 CFR Section No. of per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Record
106.100 5 10 50 400 20,000
107.50(c)(3) 3 10 30 300 9,000
Total 29,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1
No. of Annual Frequency Total Annual Hours per 21 CFR Section Respondents of Disclosure Disclosures Disclosure Total Hours
107.10(a) and 107.20 5 13 65 8 520 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA Dated: August 5, 2010. 417) (the 1984 amendments), which consulted its records of the number of Leslie Kux, authorized the approval of duplicate infant formula submissions received in Acting Assistant Commissioner for Policy. versions of drug products approved the past. All infant formula submissions [FR Doc. 2010–19640 Filed 8–9–10; 8:45 am] under an ANDA procedure. ANDA to FDA may be provided in electronic BILLING CODE 4160–01–S applicants must, with certain format. The hours per response exceptions, show that the drug for reporting estimates are based on FDA’s which they are seeking approval experience with similar programs and DEPARTMENT OF HEALTH AND contains the same active ingredient in information received from industry. HUMAN SERVICES the same strength and dosage form as the ‘‘listed drug,’’ which is a version of FDA estimates that it will receive 13 Food and Drug Administration the drug that was previously approved. reports from 5 manufacturers annually [Docket No. FDA–2009–P–0218] ANDA applicants do not have to repeat under section 412(d) of the act, for a the extensive clinical testing otherwise total annual response of 65 reports. Each Determination That DECA-DURABOLIN necessary to gain approval of a new report is estimated to take 10 hours per (Nandrolone Decanoate) Injection, 200 drug application (NDA). The only response for a total of 650 hours. FDA Milligrams/Milliliter, 1 Milliliter, Was clinical data required in an ANDA are also estimates that it will receive one Not Withdrawn From Sale for Reasons data to show that the drug that is the notification under § 106.120(b). The of Safety or Effectiveness subject of the ANDA is bioequivalent to notification is expected to take 4 hours the listed drug. per response, for a total of 4 hours. AGENCY: Food and Drug Administration, The 1984 amendments include what HHS. For exempt infant formula, FDA is now section 505(j)(7) of the Federal ACTION: estimates that it will receive 2 reports Notice. Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to from 3 manufacturers annually under SUMMARY: The Food and Drug publish a list of all approved drugs. §§ 107.50(b)(3) and (b)(4), for a total Administration (FDA) is announcing its FDA publishes this list as part of the annual response of 6 reports. Each determination that DECA-DURABOLIN ‘‘Approved Drug Products With report is estimated to take 4 hours per (nandrolone decanoate) Injection, 200 Therapeutic Equivalence Evaluations,’’ response for a total of 24 hours. FDA milligrams/milliliter (mg/mL), 1 mL, which is known generally as the also estimates that it will receive one was not withdrawn from sale for reasons ‘‘Orange Book.’’ Under FDA regulations, notification under § 107.50(e)(2). The of safety or effectiveness. This drugs are removed from the list if the determination will allow FDA to notification is expected to take four agency withdraws or suspends approval approve abbreviated new drug hours per response, for a total of four of the drug’s NDA or ANDA for reasons applications (ANDAs) for nandrolone hours. of safety or effectiveness, or if FDA decanoate, 200 mg/mL, 1 mL, if all other FDA estimates that 5 firms will determines that the listed drug was legal and regulatory requirements are expend approximately 20,000 hours per withdrawn from sale for reasons of met. year to fully satisfy the recordkeeping safety or effectiveness (21 CFR 314.162). requirements in § 106.100. It is FOR FURTHER INFORMATION CONTACT: Under 21 CFR 314.161(a)(1), the agency estimated that 3 firms will expend Nikki Mueller, Center for Drug must determine whether a listed drug approximately 9,000 hours per year to Evaluation and Research, Food and was withdrawn from sale for reasons of fully satisfy the recordkeeping Drug Administration, 10903 New safety or effectiveness before an ANDA requirements in § 107.50(c)(3). Hampshire Ave., Bldg. 51, rm. 6312, that refers to that listed drug may be Silver Spring, MD 20993–0002, 301– approved. FDA may not approve an FDA estimates that compliance with 796–3601. ANDA that does not refer to a listed the labeling requirements of §§ 107.10(a) SUPPLEMENTARY INFORMATION: In 1984, drug. and 107.20 will require 520 hours Congress enacted the Drug Price DECA-DURABOLIN (nandrolone annually by 5 manufacturers. Competition and Patent Term decanoate) Injection is the subject of Restoration Act of 1984 (Public Law 98– NDA 13–132, held by Organon, Inc.
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(Organon), and was initially approved for the approval of ANDAs are met. If exceptions, show that the drug for on October 5, 1962. Under the Drug FDA determines that labeling for this which they are seeking approval Efficacy Study Implementation (DESI), drug product should be revised to meet contains the same active ingredient in FDA concluded that nandrolone current standards, the agency will the same strength and dosage form as decanoate was effective for the advise ANDA applicants to submit such the ‘‘listed drug,’’ which is a version of indications described in the Federal labeling. the drug that was previously approved. Register notice published on July 15, Dated: August 5, 2010. ANDA applicants do not have to repeat 1983 (DESI 7630, 48 FR 32394). DECA- Leslie Kux, the extensive clinical testing otherwise DURABOLIN is an anabolic steroid necessary to gain approval of a new Acting Assistant Commissioner for Policy. indicated for the management of the drug application (NDA). The only anemia of renal insufficiency and has [FR Doc. 2010–19698 Filed 8–9–10; 8:45 am] clinical data required in an ANDA are been shown to increase hemoglobin and BILLING CODE 4160–01–S data to show that the drug that is the red cell mass. Organon notified FDA in subject of the ANDA is bioequivalent to a letter dated May 21, 2002, that it was the listed drug. no longer marketing DECA- DEPARTMENT OF HEALTH AND HUMAN SERVICES The 1984 amendments include what DURABOLIN (nandrolone decanoate) is now section 505(j)(7) of the Federal Injection, 200 mg/mL, 1 mL, and the Food and Drug Administration Food, Drug, and Cosmetic Act (the act) drug product was moved to the (21 U.S.C. 355(j)(7)), which requires ‘‘Discontinued Drug Product List’’ [Docket No. FDA–2010–N–0391] FDA to publish a list of all approved section of the Orange Book. Determination That MOTRIN drugs. FDA publishes this list as part of PharmaForce, Inc., submitted a citizen the ‘‘Approved Drug Products With petition dated May 7, 2009 (Docket No. (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn Therapeutic Equivalence Evaluations,’’ FDA–2009–P–0218), under 21 CFR which is generally known as the 10.30 requesting that the agency From Sale for Reasons of Safety or Effectiveness ‘‘Orange Book.’’ Under FDA regulations, determine whether DECA-DURABOLIN a drug is withdrawn from the list if the (nandrolone decanoate) Injection, 200 AGENCY: Food and Drug Administration, agency withdraws or suspends approval mg/mL, 1 mL, was withdrawn from sale HHS. of the drug’s NDA or ANDA for reasons for reasons of safety or effectiveness. of safety or effectiveness or if FDA FDA has reviewed its records and, ACTION: Notice. determines that the listed drug was under § 314.161, has determined that SUMMARY: The Food and Drug withdrawn from sale for reasons of DECA-DURABOLIN (nandrolone Administration (FDA) has determined safety or effectiveness (21 CFR 314.162). decanoate) Injection, 200 mg/mL, 1 mL, that the five drug products listed in this Under § 314.161(a) (21 CFR was not withdrawn from sale for reasons document were not withdrawn from of safety or effectiveness. The petitioner 314.161(a)), the agency must determine sale for reasons of safety or whether a listed drug was withdrawn identified no data or other information effectiveness. This determination means suggesting that DECA-DURABOLIN from sale for reasons of safety or that FDA will not begin procedures to effectiveness: (1) Before an ANDA that (nandrolone decanoate) Injection, 200 withdraw approval of abbreviated new mg/mL, 1 mL, was withdrawn for refers to that listed drug may be drug applications (ANDAs) that refer to approved; (2) whenever a listed drug is reasons of safety or effectiveness. FDA these drug products, and it will allow has independently evaluated relevant voluntarily withdrawn from sale and FDA to continue to approve ANDAs that ANDAs that refer to the listed drug have literature and data for possible refer to the products as long as they postmarketing adverse events and has been approved; and (3) when a person meet relevant legal and regulatory petitions for such a determination under found no information that would requirements. indicate that this product was 21 CFR 10.25(a) and 10.30. Section withdrawn from sale for reasons of FOR FURTHER INFORMATION CONTACT: 314.161(d) provides that if FDA safety or effectiveness. Accordingly, the Olivia Pritzlaff, Center for Drug determines that a listed drug was agency will continue to list DECA- Evaluation and Research, Food and withdrawn from sale for reasons of DURABOLIN (nandrolone decanoate) Drug Administration, 10903 New safety or effectiveness, the agency will Injection, 200 mg/mL, 1 mL, in the Hampshire Ave., Bldg. 51, rm. 6308, initiate proceedings that could result in ‘‘Discontinued Drug Product List’’ Silver Spring, MD 20993–0002, 301– the withdrawal of approval of the section of the Orange Book. The 796–3601. ANDAs that refer to the listed drug. ‘‘Discontinued Drug Product List’’ SUPPLEMENTARY INFORMATION: In 1984, FDA has become aware that the drug delineates, among other items, drug Congress enacted the Drug Price products listed in the table in this products that have been discontinued Competition and Patent Term document are no longer being marketed. from marketing for reasons other than Restoration Act of 1984 (Public Law 98– (As requested by the applicant, FDA safety or effectiveness. ANDAs that refer 417) (the 1984 amendments), which withdrew approval of NDA 18–354 for to DECA-DURABOLIN (nandrolone authorized the approval of duplicate ORTHO–NOVUM 10/11–21 and 10/11– decanoate) Injection, 200 mg/mL, 1 mL, versions of drug products approved 28 (ethinyl estradiol; norethindrone) may be approved by the agency if all under an ANDA procedure. ANDA Tablets in the Federal Register of other legal and regulatory requirements applicants must, with certain February 11, 2009 (74 FR 6896).)
Application No. Drug Applicant
NDA 17–463 MOTRIN (ibuprofen) Tablets, 300 milligrams (mg), 400 McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort mg, 600 mg, and 800 mg Washington, PA 19034
NDA 18–303 LOPRESSOR HCT (hydrochlorothiazide; metoprolol Novartis Pharmaceuticals Corp., 59 Rte. 10, East tartrate ) Tablets, 50 mg; 100 mg Hanover, NJ 07936–1080
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