Determination That MINOCIN (Minocycline Hydrochloride) Capsules Equivalent to 75 Milligrams Base Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 11121-11122 [E8-3879]

Download as PDF Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices duration of oral presentations to the time available. Your comments should consider the list of topics that we have proposed to the Committee and should focus on issues specific to those topics. The list of research topics to be discussed at the meeting will be available on the following Web site prior to the meeting: https:// www.cms.hhs.gov/mcd/ index_list.asp?list_type=mcac. We require that you declare at the meeting whether you have any financial involvement with manufacturers of any items or services being discussed (or with their competitors). The Committee will deliberate openly on the topics under consideration. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. 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We note that all items brought to CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: 5 U.S.C. App. 2, section 10(a). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program). Dated: February 14, 2008. Barry M. Straube, Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services. [FR Doc. E8–3829 Filed 2–28–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA–2008–P–0125] (formerly Docket No. 2007P–0172) Determination That MINOCIN (Minocycline Hydrochloride) Capsules Equivalent to 75 Milligrams Base Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its determination that MINOCIN (minocycline hydrochloride) Capsules equivalent to (EQ) 75 milligrams (mg) base was not withdrawn from sale for reasons of safety or effectiveness. This PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 11121 determination will allow FDA to approve abbreviated new drug applications (ANDAs) for minocycline hydrochloride capsules if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Regulations also provide that the agency must make a determination as to whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved (§ 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that does not refer to a listed drug. On May 1, 2007, Kendle International, on behalf of Aurobindo Pharmaceuticals, Ltd., submitted a citizen petition (Docket No. 2007P– 0172/CP1) to FDA under 21 CFR 10.30. The petition requests that the agency determine whether MINOCIN E:\FR\FM\29FEN1.SGM 29FEN1 11122 Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices (minocycline hydrochloride) Capsules EQ 75 mg base (NDA 050–649), manufactured by Triax Pharmaceuticals, Ltd. (Triax), was withdrawn from sale for reasons of safety or effectiveness. MINOCIN is a tetracycline-class antibiotic medicine used to treat certain infections caused by bacteria. MINOCIN Capsules EQ 75 mg base was approved on February 12, 2001. Our records show that the 75 mg strength of this product was marketed for a short period of time in 2001. MINOCIN Capsules EQ 75 mg base were discontinued in September 2001 and the drug product was moved from the prescription drug product list to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. FDA has reviewed its records and, under § 314.161, has determined that MINOCIN Capsules EQ 75 mg base was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that MINOCIN Capsules EQ 75 mg base was withdrawn for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list MINOCIN (minocycline hydrochloride) Capsules EQ 75 mg base in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to minocycline hydrochloride capsules EQ 75 mg base may be approved by the agency if all other legal and regulatory requirements for the approval of ANDAs are met. If FDA determines that labeling for this drug product should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: February 21, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–3879 Filed 2–28–08; 8:45 am] rwilkins on PROD1PC63 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 19:22 Feb 28, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Cancer Care for Uninsured Individuals: A Feasibility Study (NCI) Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 21, 2007 (Vol. 72, No. 245, p. 72741 and allowed 60-days for public comment. One public comment was received that questioned why the study was not funded by University of Alabama (UAB) funds. A response was made on February 8, 2008, that indicated that UAB was funding this study. The 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. Proposed Collection: Title: Cancer Care For Uninsured Individuals: A Feasibility Study. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this information collection is to assess the feasibility of obtaining health insurance information for participants of the Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial participants from health care providers and self reports. The ultimate objective is to compare the health care utilization of insured and uninsured PLCO participants. The PLCO data provides a unique opportunity to study health care seeking behavior after an abnormal cancer screening test and the effect of lack of health insurance. Participants who had positive cancer screening tests were referred to their doctors for followup care. No additional care was provided by the trial. The study collected detailed information on tests received for diagnosis, clinical presentation of disease, and cancer treatment. Since the PLCO original data collection had not recorded the health insurance of participants at the time of their screening, it is necessary to collect PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 it retrospectively. This feasibility study will request information from 50 physicians and 150 participants. The aims are to determine the: (1) Total number of physicians to be contacted to obtain insurance information on all PLCO participants who had a positive cancer screening test; (2) Percentage of physicians willing and able to provide insurance information; (3) Percentage of participants with and without insurance; (4) Number of participants for whom insurance status can be only determined by self report; (5) Percentage of PLCO participants who accept to respond to the survey; (6) Percentage of individuals who are willing to provide information on insurance status; and, (7) Potential proportion of PLCO participants without health insurance. These results will be used to design a study to examine the health care behavior of insured and uninsured PLCO participants. This is relevant to understand the results of the PLCO Cancer Screening Trial and other screening trials currently being conducted in the U.S. The success of these trials is conditional on participants’ access to care following a recommendation for follow-up. Uninsured individuals may be more likely to join these trials than insured ones in order to get free preventive care. They may also be more likely to not seek, or delay seeking, care after an abnormal screening test even though they are encouraged to get care and they may be highly motivated to receive the best care possible. It is relevant for other decision makers to understand whether uninsured persons are receiving appropriate care after abnormal screening results. The efforts to control cancer disease and the loss of life associated with it are concentrated on population wide screening. These endeavors may be compromised if a significant proportion of the population does not get appropriate follow-up after screening or does not get the care known to be effective for their disease. Frequency of Response: One time. Affected Public: Individuals and households; businesses or other forprofit. Type of Respondents: Individuals older than 55 who participated in the PLCO Screening trial and physicians who provided care for them. The annual reporting burden is shown in the following table. E:\FR\FM\29FEN1.SGM 29FEN1

Agencies

[Federal Register Volume 73, Number 41 (Friday, February 29, 2008)]
[Notices]
[Pages 11121-11122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3879]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2008-P-0125] (formerly Docket No. 2007P-0172)


Determination That MINOCIN (Minocycline Hydrochloride) Capsules 
Equivalent to 75 Milligrams Base Was Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
determination that MINOCIN (minocycline hydrochloride) Capsules 
equivalent to (EQ) 75 milligrams (mg) base was not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDAs) for 
minocycline hydrochloride capsules if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162). Regulations also provide that the 
agency must make a determination as to whether a listed drug was 
withdrawn from sale for reasons of safety or effectiveness before an 
ANDA that refers to that listed drug may be approved (Sec.  
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that 
does not refer to a listed drug.
    On May 1, 2007, Kendle International, on behalf of Aurobindo 
Pharmaceuticals, Ltd., submitted a citizen petition (Docket No. 2007P-
0172/CP1) to FDA under 21 CFR 10.30. The petition requests that the 
agency determine whether MINOCIN

[[Page 11122]]

(minocycline hydrochloride) Capsules EQ 75 mg base (NDA 050-649), 
manufactured by Triax Pharmaceuticals, Ltd. (Triax), was withdrawn from 
sale for reasons of safety or effectiveness. MINOCIN is a tetracycline-
class antibiotic medicine used to treat certain infections caused by 
bacteria. MINOCIN Capsules EQ 75 mg base was approved on February 12, 
2001. Our records show that the 75 mg strength of this product was 
marketed for a short period of time in 2001. MINOCIN Capsules EQ 75 mg 
base were discontinued in September 2001 and the drug product was moved 
from the prescription drug product list to the ``Discontinued Drug 
Product List'' section of the Orange Book.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that MINOCIN Capsules EQ 75 mg base was not withdrawn from 
sale for reasons of safety or effectiveness. The petitioner identified 
no data or other information suggesting that MINOCIN Capsules EQ 75 mg 
base was withdrawn for reasons of safety or effectiveness. FDA has 
independently evaluated relevant literature and data for possible 
postmarketing adverse events and has found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness. Accordingly, the agency will continue to list 
MINOCIN (minocycline hydrochloride) Capsules EQ 75 mg base in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' delineates, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness. ANDAs that refer to minocycline 
hydrochloride capsules EQ 75 mg base may be approved by the agency if 
all other legal and regulatory requirements for the approval of ANDAs 
are met. If FDA determines that labeling for this drug product should 
be revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.

    Dated: February 21, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3879 Filed 2-28-08; 8:45 am]
BILLING CODE 4160-01-S

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