81 FR 45509 - Bacterial Vaginosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 135 (July 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 135 (July 14, 2016)
| Page Range | 45509-45510 | |
| FR Document | 2016-16636 |
[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)] [Notices] [Pages 45509-45510] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16636] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1659] Bacterial Vaginosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bacterial Vaginosis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of bacterial vaginosis (BV). 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 12, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-1659 for ``Bacterial Vaginosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, 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 draft guidance document. [[Page 45510]] FOR FURTHER INFORMATION CONTACT: Edward Weinstein, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6382, Silver Spring, MD 20993-0002, 301- 796-1400. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Bacterial Vaginosis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of BV. This draft guidance helps define enrollment criteria for BV trials and recommends that such trials be superiority trials. The draft guidance reflects recent developments in scientific information that pertain to drugs being developed for the treatment of BV, including the characterization of the primary efficacy endpoint. 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. In 1998, FDA published a draft guidance entitled ``Bacterial Vaginosis--Developing Antimicrobial Drugs for Treatment'' (the 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 guidance. 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 current thinking of FDA on this topic. 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. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: July 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-16636 Filed 7-13-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices 45509
importers, who will have more Treatment.’’ The purpose of this Guidance for Industry; Availability.’’
responsibility for the safety of imported guidance is to assist sponsors in the Received comments will be placed in
foods. clinical development of drugs for the the docket and, except for those
Beyond FSMA’s implementation, the treatment of bacterial vaginosis (BV). submitted as ‘‘Confidential
FVM Program Strategic Plan provides DATES: Although you can comment on Submissions,’’ publicly viewable at
details on our goals of protecting and any guidance at any time (see 21 CFR http://www.regulations.gov or at the
enhancing the health of people and 10.115(g)(5)), to ensure that the Agency Division of Dockets Management
animals. The active engagement of all considers your comment on this draft between 9 a.m. and 4 p.m., Monday
stakeholders and partners, both internal guidance before it begins work on the through Friday.
and external, is critical to the successful final version of the guidance, submit • Confidential Submissions—To
implementation of this plan. either electronic or written comments submit a comment with confidential
on the draft guidance by October 12, information that you do not wish to be
II. Electronic Access made publicly available, submit your
2016.
Persons with access to the Internet comments only as a written/paper
ADDRESSES: You may submit comments submission. You should submit two
may obtain the FVM Program Strategic
as follows: copies total. One copy will include the
Plan at http://www.regulations.gov.
Electronic Submissions information you claim to be confidential
III. References with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
The following references have been
following way: CONFIDENTIAL INFORMATION.’’ The
placed on display in the Division of
• Federal eRulemaking Portal: http:// Agency will review this copy, including
Dockets Management (see ADDRESSES)
www.regulations.gov. Follow the the claimed confidential information, in
and may be seen by interested persons
instructions for submitting comments. its consideration of comments. The
between 9 a.m. and 4 p.m., Monday
Comments submitted electronically, second copy, which will have the
through Friday, and are available
including attachments, to http:// claimed confidential information
electronically at http://
www.regulations.gov will be posted to redacted/blacked out, will be available
www.regulations.gov. (FDA has verified
the docket unchanged. Because your for public viewing and posted on http://
the Web site addresses in this reference
comment will be made public, you are www.regulations.gov. Submit both
section, but we are not responsible for
solely responsible for ensuring that your copies to the Division of Dockets
any subsequent changes to the Web sites
comment does not include any Management. If you do not wish your
after this document publishes in the
confidential information that you or a name and contact information to be
Federal Register.)
third party may not wish to be posted, made publicly available, you can
1. FDA Foods and Veterinary Medicine such as medical information, your or provide this information on the cover
Program Strategic Plan, FY 2016–2025, anyone else’s Social Security number, or
available at http://www.fda.gov/
sheet and not in the body of your
confidential business information, such comments and you must identify this
aboutfda/centersoffices/officeoffoods/
ucm273269.htm.
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
2. Partnership for Food Protection (PFP) that if you include your name, contact information marked as ‘‘confidential’’
Strategic Plan FY 2015 through 2020, information, or other information that will not be disclosed except in
available at http://www.fda.gov/ identifies you in the body of your accordance with 21 CFR 10.20 and other
downloads/ForFederalStateand comments, that information will be applicable disclosure law. For more
LocalOfficials/FoodSafetySystem/ posted on http://www.regulations.gov. information about FDA’s posting of
PartnershipforFoodProtectionPFP/ • If you want to submit a comment comments to public dockets, see 80 FR
UCM423834.pdf. with confidential information that you 56469, September 18, 2015, or access
Dated: July 11, 2016. do not wish to be made available to the the information at: http://www.fda.gov/
Leslie Kux, public, submit the comment as a regulatoryinformation/dockets/
Associate Commissioner for Policy. written/paper submission and in the default.htm.
[FR Doc. 2016–16684 Filed 7–13–16; 8:45 am]
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
BILLING CODE 4164–01–P
electronic and written/paper comments
Written/Paper Submissions
received, go to http://
DEPARTMENT OF HEALTH AND Submit written/paper submissions as www.regulations.gov and insert the
HUMAN SERVICES follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
Food and Drug Administration written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food and/or go to the Division of Dockets
[Docket No. FDA–2016–D–1659] and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
Bacterial Vaginosis: Developing Drugs
• For written/paper comments Submit written requests for single
for Treatment; Draft Guidance for
submitted to the Division of Dockets copies of the draft guidance to the
Industry; Availability
Management, FDA will post your Division of Drug Information, Center for
comment, as well as any attachments, Drug Evaluation and Research, Food
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration,
HHS. except for information submitted, and Drug Administration, 10001 New
ACTION: Notice of availability. marked and identified, as confidential, Hampshire Ave., Hillandale Building,
if submitted as detailed in 4th Floor, Silver Spring, MD 20993–
SUMMARY: The Food and Drug ‘‘Instructions.’’ 0002. Send one self-addressed adhesive
Administration (FDA or Agency) is Instructions: All submissions received label to assist that office in processing
announcing the availability of a draft must include the Docket No. FDA– your requests. See the SUPPLEMENTARY
guidance for industry entitled ‘‘Bacterial 2016–D–1659 for ‘‘Bacterial Vaginosis: INFORMATION section for electronic
Vaginosis: Developing Drugs for Developing Drugs for Treatment; Draft access to the draft guidance document.
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![45510 Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
FOR FURTHER INFORMATION CONTACT: II. The Paperwork Reduction Act of Reauthorization Act of 2010 (Pub. L.
Edward Weinstein, Center for Drug 1995 111–358).
Evaluation and Research, Food and This guidance refers to previously DATES:
Drug Administration, 10903 New approved collections of information that • Submission period begins: July 7,
Hampshire Ave., Bldg. 22, Rm. 6382, are subject to review by the Office of 2016.
Silver Spring, MD 20993–0002, 301– Management and Budget (OMB) under • Submission period ends: August 8,
796–1400. the Paperwork Reduction Act of 1995 2016.
SUPPLEMENTARY INFORMATION: (44 U.S.C. 3501–3520). The collections • Evaluation begins: August 9, 2016.
of information in 21 CFR parts 312 and • Evaluation ends: August 19, 2016.
I. Background 314 have been approved under OMB • Winners notified: August 22, 2016.
control numbers 0910–0014 and 0910– • Winners Announced: August 29,
FDA is announcing the availability of 2016.
a draft guidance for industry entitled 0001, respectively.
• Winner Presentation: September
‘‘Bacterial Vaginosis: Developing Drugs III. Electronic Access 26–27, 2016.
for Treatment.’’ The purpose of this Persons with access to the Internet
guidance is to assist sponsors in the FOR FURTHER INFORMATION CONTACT:
may obtain the draft guidance at either Debbie Bucci, debbie.bucci@hhs.gov
development of drugs for the treatment http://www.fda.gov/Drugs/Guidance
of BV. This draft guidance helps define (preferred), (202) 690–0213.
ComplianceRegulatoryInformation/
enrollment criteria for BV trials and SUPPLEMENTARY INFORMATION:
Guidances/default.htm or http://
recommends that such trials be www.regulations.gov. Subject of Challenge
superiority trials. The draft guidance
Dated: July 8, 2016. A Blockchain is a data structure that
reflects recent developments in
scientific information that pertain to Leslie Kux, can be timed-stamped and signed using
drugs being developed for the treatment Associate Commissioner for Policy. a private key to prevent tampering.
of BV, including the characterization of [FR Doc. 2016–16636 Filed 7–13–16; 8:45 am] There are generally three types of
the primary efficacy endpoint. BILLING CODE 4164–01–P Blockchain: Public, private and
consortium. Potential uses include:
Issuance of this guidance fulfills a • Digitally sign information,
portion of the requirements of Title VIII, • Computable enforcement of policies
DEPARTMENT OF HEALTH AND
section 804, of the Food and Drug and contracts (smart contracts),
HUMAN SERVICES
Administration Safety and Innovation • Management of Internet of Things
Act (Pub. L. 112–144), which requires Office of the National Coordinator for devices,
FDA to review and, as appropriate, Health Information Technology; • Distributed encrypted storage, and
revise not fewer than three guidance Announcement of Requirements and • Distributed trust.
documents per year for the conduct of Registration for ‘‘Blockchain and its This Ideation Challenge solicits White
clinical trials with respect to Emerging Role in Health IT and Health- Papers on the topic of Blockchain
antibacterial and antifungal drugs. In related Research’’; Amendment Technology and the Potential for Its Use
1998, FDA published a draft guidance in Health IT and/or Healthcare Related
entitled ‘‘Bacterial Vaginosis— AGENCY: Office of the National
Coordinator for Health Information Research Data. This nationwide call
Developing Antimicrobial Drugs for may be addressed by an individual
Treatment’’ (the 1998 draft guidance). In Technology, HHS. Award Approving
Official: Karen DeSalvo, National investigator or an investigator team.
a Federal Register notice dated August Interested parties should submit a White
7, 2013 (78 FR 48175), FDA announced Coordinator for Health Information
Technology. Paper no longer than 10 pages
an initiative in the Center for Drug describing the proposed subject.
Evaluation and Research involving the ACTION: Notice; Amendment.
Investigators or co-investigators may
review of draft guidance documents SUMMARY: This document amends the only participate in one submission. Up
issued before 2010 to determine their notice published in Federal Register, to 15 of these submissions will be
status and to decide whether those Friday July 8, 2016, volume 81, pages selected as winners. The selection of a
guidances should be withdrawn, 44639–44640. This notice updates and White Paper may also result in an
revised, or finalized with only minor extends the submission period to invitation to present at an upcoming
changes. In the August 7, 2013, Federal August 8, 2016, limits an investigator or industry-wide workshop on September
Register notice, FDA announced that co-investigator to one submission and 26th–27th, 2016, at NIST Headquarters
the 1998 draft guidance, as well as other adds prize details. The ‘‘Use of in Gaithersburg, MD.
draft guidances, was being withdrawn Blockchain in Health IT and Health-
(78 FR 48175). FDA is now issuing a related Research’’ Ideation Challenge Objective
new draft guidance that revises the solicits white papers on the topic of The goal of this Ideation Challenge is
recommendations in the 1998 draft Blockchain Technology and the to solicit White Papers that investigate
guidance. potential use in Health IT to address the relationship between Blockchain
This draft guidance is being issued privacy, security and scalability technology and its use in Health IT and/
consistent with FDA’s good guidance challenges of managing electronic or Health Related research. The paper
practices regulation (21 CFR 10.115). health record and resources. Up to 15 should discuss the cryptography and
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The draft guidance, when finalized, will winners will be awarded a cash prize underlying fundamentals of Blockchain
represent the current thinking of FDA and up to 8 winners may be invited to technology, examine how the use of
on this topic. It does not establish any present their papers at an upcoming Blockchain can advance industry
rights for any person and is not binding industry-wide workshop co-hosted with interoperability needs expressed in the
on FDA or the public. You can use an the National Institute of Standards and ONC’s Shared Nationwide
alternative approach if it satisfies the Technology (NIST). The statutory Interoperability Roadmap, as well as for
requirements of the applicable statutes authority for this Challenge is section Patient Centered Outcomes Research
and regulations. 105 of the America COMPETES (PCOR), the Precision Medicine
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Document Created: 2016-07-14 01:54:44
Document Modified: 2016-07-14 01:54:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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 October 12, 2016. | |
| Contact | Edward Weinstein, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6382, Silver Spring, MD 20993-0002, 301- 796-1400. | |
| FR Citation | 81 FR 45509 |
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