Draft Guidance for Industry on Uncomplicated Gonorrhea: Developing Drugs for Treatment; Availability, 35172-35173 [2014-14303]

Download as PDF 35172 Federal Register / Vol. 79, No. 118 / Thursday, June 19, 2014 / Notices TABLE 1—Continued Application No. Drug Applicant ANDA 089420 ............................. ANDA 090183 ............................. ANDA 090196 ............................. ANDA 090464 ............................. Azdone Tablets (hydrocodone bitartrate 5 mg and aspirin 500 mg). Cetirizine HCl Syrup, 5 mg/5mL .................................. Letrozole Tablets USP, 2.5 mg ................................... Mycophenolate Mofetil Tablets, 500 mg ..................... ANDA 090567 ............................. Polyethylene Glycol 3350 Powder for Oral Solution ... ANDA 090712 ............................. Polyethylene Glycol 3350 and Electrolytes for Oral Solution. Clenz-Lyte (polyethylene glyol 3350 and electrolytes for oral solution). Mycophenolalte Mofetil Capsules USP, 250 mg ......... Schwarz Pharma, Inc., c/o UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080. Ranbaxy Laboratories Limited, c/o Ranbaxy Inc. Synthon Pharmaceuticals, Inc. Dr. Reddy’s Laboratories Limited, c/o Dr. Reddy’s Laboratories, Inc., 200 Somerset Corporate Blvd., 7th Floor, Bridgewater, NJ 08807. Paddock Laboratories, LLC, a Perrigo Co., 3940 Quebec Ave. North, Minneapolis, MN 55427. Do. ANDA 090769 ............................. ANDA 091315 ............................. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective July 21, 2014. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: June 13, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–14288 Filed 6–18–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0640] emcdonald on DSK67QTVN1PROD with NOTICES Draft Guidance for Industry on Uncomplicated Gonorrhea: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Uncomplicated SUMMARY: VerDate Mar<15>2010 17:25 Jun 18, 2014 Jkt 232001 Do. Dr. Reddy’s Laboratories Limited, c/o Dr. Reddy’s Laboratories, Inc. Gonorrhea: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 17, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993–0002, 301– 796–1300. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Uncomplicated Gonorrhea: Developing Drugs for Treatment.’’ The purpose of PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 this draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea. This draft guidance describes approaches for trial designs for the evaluation of new drugs for the treatment of uncomplicated gonorrhea. The draft guidance focuses on the noninferiority trial design and describes an efficacy endpoint for which there is a well-defined treatment effect. The draft guidance also provides the justification for the noninferiority margin. In addition, this guidance reflects recent developments in scientific information that pertain to drugs being developed for the treatment of uncomplicated gonorrhea. Issuance of this draft guidance fulfills a portion of the requirements of Title VIII, section 804, of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) that requires FDA to ‘‘. . . review and, as appropriate, revise not fewer than 3 guidance documents per year . . . for the conduct of clinical trials with respect to antibacterial and antifungal drugs. . . .’’ In 1998, FDA published a draft guidance entitled ‘‘Uncomplicated Gonorrhea: Developing Drugs for Treatment’’ (1998 draft guidance). In a Federal Register notice dated August 7, 2013 (78 FR 48175), FDA announced an initiative in the Center for Drug Evaluation and Research involving the review of draft guidance documents issued before 2010 to determine their status and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. In the August 7, 2013, Federal Register notice, FDA announced that the 1998 draft guidance, as well as other draft guidances, was being withdrawn (78 FR 48175). FDA is now issuing a new draft guidance that revises the recommendations in the 1998 draft E:\FR\FM\19JNN1.SGM 19JNN1 Federal Register / Vol. 79, No. 118 / Thursday, June 19, 2014 / Notices guidance. Issuance of the new draft guidance constitutes a revision of a previously published draft guidance and fulfills a portion of the requirements of Public Law 112–144. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on developing drugs for the treatment of uncomplicated gonorrhea. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910–0001, respectively. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access emcdonald on DSK67QTVN1PROD with NOTICES Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: June 12, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–14303 Filed 6–18–14; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:25 Jun 18, 2014 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Biological Data Management and Analysis. Date: June 25, 2014. Time: 10 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Mark Caprara, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5156, MSC 7844, Bethesda, MD 20892, 301–435– 1042, capraramg@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Single Cell Analysis. Date: July 1–2, 2014. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Amy L. Rubinstein, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5152, MSC 7844, Bethesda, MD 20892, 301–408– 9754, rubinsteinal@csr.nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group; AIDSassociated Opportunistic Infections and Cancer Study Section. Date: July 11, 2014. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: The St. Regis Washington DC, 923 16th Street NW., Washington, DC 20006. Contact Person: Eduardo A. Montalvo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 35173 Health, 6701 Rockledge Drive, Room 5108, MSC 7852, Bethesda, MD 20892, (301) 435– 1168, montalve@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Omnibus Solicitation of the NIH for Small Business. Date: July 11, 2014. Time: 10 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Rebecca Henry, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3222, MSC 7808, Bethesda, MD 20892, 301–435– 1717, henryrr@mail.nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group; HIV/ AIDS Vaccines Study Section. Date: July 15, 2014. Time: 8:30 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Row Hotel, 2015 Massachusetts Avenue NW., Washington, DC 20036. Contact Person: Mary Clare Walker, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435– 1165, walkermc@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Oncology. Date: July 16–17, 2014. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Michael L. Bloom, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD 20892, 301–451– 0132, bloomm2@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Nutrition, Obesity and Diabetes. Date: July 16, 2014. Time: 10 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Nancy Sheard, SCD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6046–E, MSC 7892, Bethesda, MD 20892, 301–408– 9901, sheardn@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Shared Instrumentation: Flow Cytometry. Date: July 16, 2014. Time: 11 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). E:\FR\FM\19JNN1.SGM 19JNN1

Agencies

[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Pages 35172-35173]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14303]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0640]


Draft Guidance for Industry on Uncomplicated Gonorrhea: 
Developing Drugs for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Uncomplicated 
Gonorrhea: Developing Drugs for Treatment.'' The purpose of this draft 
guidance is to assist sponsors in the development of new antibacterial 
drugs for the treatment of uncomplicated gonorrhea.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 17, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' 
The purpose of this draft guidance is to assist sponsors in the 
development of new antibacterial drugs for the treatment of 
uncomplicated gonorrhea.
    This draft guidance describes approaches for trial designs for the 
evaluation of new drugs for the treatment of uncomplicated gonorrhea. 
The draft guidance focuses on the noninferiority trial design and 
describes an efficacy endpoint for which there is a well-defined 
treatment effect. The draft guidance also provides the justification 
for the noninferiority margin. In addition, this guidance reflects 
recent developments in scientific information that pertain to drugs 
being developed for the treatment of uncomplicated gonorrhea.
    Issuance of this draft guidance fulfills a portion of the 
requirements of Title VIII, section 804, of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) that 
requires FDA to ``. . . review and, as appropriate, revise not fewer 
than 3 guidance documents per year . . . for the conduct of clinical 
trials with respect to antibacterial and antifungal drugs. . . .'' In 
1998, FDA published a draft guidance entitled ``Uncomplicated 
Gonorrhea: Developing Drugs for Treatment'' (1998 draft guidance). In a 
Federal Register notice dated August 7, 2013 (78 FR 48175), FDA 
announced an initiative in the Center for Drug Evaluation and Research 
involving the review of draft guidance documents issued before 2010 to 
determine their status and to decide whether those guidances should be 
withdrawn, revised, or finalized with only minor changes. In the August 
7, 2013, Federal Register notice, FDA announced that the 1998 draft 
guidance, as well as other draft guidances, was being withdrawn (78 FR 
48175). FDA is now issuing a new draft guidance that revises the 
recommendations in the 1998 draft

[[Page 35173]]

guidance. Issuance of the new draft guidance constitutes a revision of 
a previously published draft guidance and fulfills a portion of the 
requirements of Public Law 112-144.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on developing 
drugs for the treatment of uncomplicated gonorrhea. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14303 Filed 6-18-14; 8:45 am]
BILLING CODE 4160-01-P
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