80_FR_50168 80 FR 50009 - Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability

80 FR 50009 - Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

Page Range50009-50010
FR Document2015-20306

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated gonorrhea. This guidance finalizes the draft guidance of the same name issued on June 19, 2014.

Federal Register, Volume 80 Issue 159 (Tuesday, August 18, 2015) 
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50009-50010]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Uncomplicated 
Gonorrhea: Developing Drugs for Treatment.'' The purpose of this 
guidance is to assist sponsors in the clinical development of drugs for 
the treatment of uncomplicated gonorrhea. This guidance finalizes the 
draft guidance of the same name issued on June 19, 2014.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, 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 guidance document.
    Submit electronic comments on the guidance to http://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: Maria Allende or Joseph Toerner, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-
0002, 301-796-1400.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' 
The purpose of this guidance is to assist sponsors in the development 
of drugs for the treatment of uncomplicated gonorrhea.
    This guidance describes approaches for trial designs for the 
evaluation of new drugs for the treatment of uncomplicated gonorrhea. 
The guidance focuses on the noninferiority trial design and describes 
an efficacy endpoint for which there is a well-defined treatment 
effect. The guidance also provides the justification for the 
noninferiority margin. After careful consideration of comments received 
in response to the draft guidance issued on June 19, 2014 (79 FR 
35172), we added a brief discussion of the potential for pregnant women 
to be included in specific populations for drug development. In 
addition, this guidance

[[Page 50010]]

reflects recent developments in scientific information that pertain to 
drugs being developed for the treatment of uncomplicated gonorrhea.
    Issuance of this guidance fulfills a portion of the requirements of 
Title VIII, section 804, of the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-144), which requires FDA to review and, as 
appropriate, revise not fewer than three guidance documents per year 
for the conduct of clinical trials with respect to antibacterial and 
antifungal drugs.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on developing drugs for the treatment of 
uncomplicated gonorrhea. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This 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 http://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 http://www.regulations.gov.

IV. Electronic Access

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

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20306 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50009 sections of the existing ‘‘Non-Clinical Center for Devices and Radiological SUMMARY: The Food and Drug Engineering Tests and Recommended Health guidance documents is available Administration (FDA or Agency) is Labeling for Intravascular Stents and at http://www.fda.gov/MedicalDevices/ announcing the availability of a Associated Delivery Systems’’ guidance. DeviceRegulationandGuidance/ guidance for industry entitled In the Federal Register on August 30, GuidanceDocuments/default.htm. ‘‘Uncomplicated Gonorrhea: Developing 2013 (78 FR 53773), FDA announced the Guidance documents are also available Drugs for Treatment.’’ The purpose of availability of the draft guidance at http://www.regulations.gov. Persons this guidance is to assist sponsors in the document. Interested persons were unable to download an electronic copy clinical development of drugs for the invited to comment by September 30, of ‘‘Select Updates for Non-Clinical treatment of uncomplicated gonorrhea. 2013. Four sets of comments were Engineering Tests and Recommended This guidance finalizes the draft received and, in general, were Labeling for Intravascular Stents and guidance of the same name issued on supportive of the guidance. There were Associated Delivery Systems ’’ may June 19, 2014. multiple comments regarding the need send an email request to CDRH- DATES: Submit either electronic or for clarification of acceptance criteria Guidance@fda.hhs.gov to receive an written comments on Agency guidances and the desire for a flow chart to electronic copy of the document. Please at any time. visualize the overall testing paradigm use the document number 1826 to ADDRESSES: Submit written requests for described in the guidance update. In identify the guidance you are single copies of this guidance to the response to these comments, FDA requesting. Division of Drug Information, Center for revised the guidance document to IV. Paperwork Reduction Act of 1995 Drug Evaluation and Research, Food include more specific information on and Drug Administration, 10001 New acceptance criteria for pitting corrosion This draft guidance refers to Hampshire Ave., Hillandale Building, and surface oxide properties, as well as previously approved collections of 4th Floor, Silver Spring, MD 20993– a flow chart. General concerns were information found in FDA regulations. 0002. Send one self-addressed adhesive noted that the guidance modifications These collections of information are might be interpreted to be more label to assist that office in processing subject to review by the Office of your requests. See the SUPPLEMENTARY burdensome. However, the addition of Management and Budget (OMB) under INFORMATION section for electronic the flowchart is intended to clarify the Paperwork Reduction Act of 1995 when testing beyond pitting corrosion access to the guidance document. (44 U.S.C. 3501–3520). The collections Submit electronic comments on the testing should be considered, and based of information in 21 CFR part 814 have guidance to http://www.regulations.gov. on prior experience, it is anticipated been approved under OMB control Submit written comments to the that few stents will need further number 0910–0231. assessment. In addition, there were Division of Dockets Management (HFA– several comments regarding the lack of V. Comments 305), Food and Drug Administration, utility of post-fatigue pitting corrosion 5630 Fishers Lane, Rm. 1061, Rockville, Interested persons may submit either MD 20852. assessment. In response to these electronic comments regarding this comments, as well as discussions at the FOR FURTHER INFORMATION CONTACT: document to http://www.regulations.gov March 2012 workshop, FDA has Maria Allende or Joseph Toerner, Center or written comments to the Division of removed the suggestion to consider for Drug Evaluation and Research, Food Dockets Management (see ADDRESSES). It post-fatigue pitting corrosion testing and Drug Administration, 10903 New is only necessary to send one set of when damage to samples is noted due Hampshire Ave., Bldg. 22, Rm. 6244, comments. Identify comments with the to fatigue testing. There was also a Silver Spring, MD 20993–0002, 301– docket number found in brackets in the comment that the 60-day suggested 796–1400. heading of this document. Received duration for nickel release may be comments may be seen in the Division SUPPLEMENTARY INFORMATION: unnecessarily long and burdensome, of Dockets Management between 9 a.m. I. Background and in response, FDA has reduced the and 4 p.m., Monday through Friday, and minimum duration to 30 days if the FDA is announcing the availability of will be posted to the docket at http:// release rate falls below a predetermined a guidance for industry entitled www.regulations.gov. level based on toxicological risk ‘‘Uncomplicated Gonorrhea: Developing Dated: August 12, 2015. Drugs for Treatment.’’ The purpose of assessment. Leslie Kux, this guidance is to assist sponsors in the II. Significance of Guidance Associate Commissioner for Policy. development of drugs for the treatment This guidance is being issued [FR Doc. 2015–20308 Filed 8–17–15; 8:45 am] of uncomplicated gonorrhea. consistent with FDA’s good guidance BILLING CODE 4164–01–P This guidance describes approaches practices regulation (21 CFR 10.115). for trial designs for the evaluation of The guidance represents the current new drugs for the treatment of thinking of FDA on certain non-clinical DEPARTMENT OF HEALTH AND uncomplicated gonorrhea. The guidance testing for coronary and peripheral HUMAN SERVICES focuses on the noninferiority trial stents. It does not establish any rights design and describes an efficacy for any person and is not binding on Food and Drug Administration endpoint for which there is a well- FDA or the public. You can use an defined treatment effect. The guidance [Docket No. FDA–2014–D–0640] also provides the justification for the asabaliauskas on DSK5VPTVN1PROD with NOTICES alternative approach if it satisfies the requirements of the applicable statute noninferiority margin. After careful Uncomplicated Gonorrhea: Developing consideration of comments received in and regulations. Drugs for Treatment; Guidance for response to the draft guidance issued on III. Electronic Access Industry; Availability June 19, 2014 (79 FR 35172), we added Persons interested in obtaining a copy AGENCY: Food and Drug Administration, a brief discussion of the potential for of the guidance may do so by HHS. pregnant women to be included in downloading an electronic copy from specific populations for drug ACTION: Notice. the Internet. A search capability for all development. In addition, this guidance VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1

50010 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices reflects recent developments in Dated: August 12, 2015. published in the Federal Register or by scientific information that pertain to Leslie Kux, letter to the person who is the drugs being developed for the treatment Associate Commissioner for Policy. manufacturer or importer of the device, of uncomplicated gonorrhea. [FR Doc. 2015–20306 Filed 8–17–15; 8:45 am] indicated should be subject to part 803 in order to protect the public health— Issuance of this guidance fulfills a BILLING CODE 4164–01–P be submitted in accordance with the portion of the requirements of Title VIII, criteria established by FDA (section section 804, of the Food and Drug 519(a)(1)(B)(ii) of the FD&C Act).1 The Administration Safety and Innovation DEPARTMENT OF HEALTH AND HUMAN SERVICES criteria must require the reports to be in Act (Pub. L. 112–144), which requires summary form and made on a quarterly FDA to review and, as appropriate, Food and Drug Administration basis (section 519(a)(1)(B)(ii) of the revise not fewer than three guidance FD&C Act). documents per year for the conduct of [Docket No. FDA–2015–N–2918] FDA is considering the development clinical trials with respect to Pilot Program for Medical Device of malfunction reporting criteria for antibacterial and antifungal drugs. Reporting on Malfunctions devices subject to section 519(a)(1)(B)(ii) This guidance is being issued of the FD&C Act. In the interim, FDA consistent with FDA’s good guidance AGENCY: Food and Drug Administration, clarified that all manufacturers of class HHS. I devices and those class II devices that practices regulation (21 CFR 10.115). ACTION: Notice. are not permanently implantable, life The guidance represents the current supporting, or life sustaining, must thinking of FDA on developing drugs for SUMMARY: The Food and Drug continue to report in full compliance the treatment of uncomplicated Administration (FDA) is soliciting with part 803 (76 FR 12743 at 12744, gonorrhea. It does not establish any nominations for participation in a pilot March 8, 2011). rights for any person and is not binding program for the submission of medical The malfunction reporting on FDA or the public. You can use an device reports for malfunctions of class requirements for class III devices and alternative approach if it satisfies the I devices and certain class II devices in those class II devices that are requirements of the applicable statutes summary format on a quarterly basis. permanently implantable, life and regulations. Under the Medical Device Reporting on supporting, or life sustaining were not Malfunctions pilot program, FDA altered by FDAAA. Under the amended II. The Paperwork Reduction Act of intends to work with manufacturers to section 519(a) of the FD&C Act, device 1995 identify candidates for the pilot program manufacturers are to continue to submit This guidance refers to previously and intends to continue to accept malfunction reports in accordance with approved collections of information that nominations until candidates for the part 803 for all class III devices and for are subject to review by the Office of pilot program have been selected. those class II devices that are Management and Budget (OMB) under DATES: FDA will begin accepting permanently implantable, life nominations for participation in the supporting, or life sustaining, unless the Paperwork Reduction Act of 1995 voluntary pilot program on September FDA grants an exemption or variance (44 U.S.C. 3501–3520). The collections 1, 2015, and intends to continue to from, or an alternative to, a requirement of information in 21 CFR parts 312 and accept nominations until candidates for under such regulations under § 803.19 314 have been approved under OMB (section 519(a)(1)(B)(i) of the FD&C Act). control numbers 0910–0014 and 0910– the pilot program have been selected. See section II for instructions on how to In addition, under section 519(a) of 0001, respectively. the FD&C Act, as amended by FDAAA, participate in the voluntary pilot III. Comments program. there is no change to the obligation for an importer to submit malfunction FOR FURTHER INFORMATION CONTACT: Interested persons may submit either reports to the manufacturer in William C. Maloney, Center for Devices accordance with part 803 for devices electronic comments regarding this and Radiological Health, 10903 New that it imports into the United States document to http://www.regulations.gov Hampshire Ave., Bldg. 66, Rm. 3236, (section 519(a)(1)(B)(iii) of the FD&C or written comments to the Division of Silver Spring, MD 20993–0002, Act). Dockets Management (see ADDRESSES). It 227pilot@fda.hhs.gov. is only necessary to send one set of FDA intends to use the information SUPPLEMENTARY INFORMATION: learned and experiences gained from the comments. Identify comments with the docket number found in brackets in the I. Background pilot program to develop the heading of this document. Received malfunction reporting criteria for The Food and Drug Administration devices subject to section 519(a)(1)(B)(ii) comments may be seen in the Division Amendments Act of 2007 (FDAAA) of the FD&C Act. of Dockets Management between 9 a.m. (Pub. L. 110–85), amended section and 4 p.m., Monday through Friday and 519(a) of the Federal Food, Drug, and II. Pilot Program for Medical Device will be posted to the docket at http:// Cosmetic Act (the FD&C Act) (21 U.S.C. Reporting (MDR) on Malfunctions www.regulations.gov. 360i(a)), relating to the reporting of FDA has developed this pilot program device malfunctions to FDA under part for manufacturers interested in IV. Electronic Access 803 (21 CFR part 803). Specifically, submitting malfunction reports for asabaliauskas on DSK5VPTVN1PROD with NOTICES Persons with access to the Internet FDAAA amended the FD&C Act to certain devices in a summary format on may obtain the document at either require that medical device reports of a quarterly basis. This notice provides: http://www.fda.gov/Drugs/ malfunctions for class I devices and GuidanceCompliance/ those class II devices that are not 1 In light of section 1003(d) of the FD&C Act (21 permanently implantable, life U.S.C. 393(d)) and the Secretary of Health and RegulatoryInformation/Guidances/ Human Services’ (the Secretary’s) delegation to the default.htm or http:// supporting, or life sustaining—with the Commissioner of Food and Drugs, statutory www.regulations.gov. exception of any type of class I or II references to ‘‘the Secretary’’ have been changed to device which FDA has, by notice, ‘‘FDA’’ or the ‘‘Agency’’ in this document. VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1


Document Created: 2015-12-15 12:05:18
Document Modified: 2015-12-15 12:05:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactMaria Allende or Joseph Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993- 0002, 301-796-1400.
FR Citation80 FR 50009 
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