Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, 43212-43214 [2016-15661]
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
43212
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–1692 for Elemental Impurities
in Drug Products. Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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 https://
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: https://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 https://
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copies of the draft guidance to the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; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
VerDate Sep<11>2014
19:05 Jun 30, 2016
Jkt 238001
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, 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.
FOR FURTHER INFORMATION CONTACT: John
Kauffman, Center for Drug Evaluation
and Research (HFD–920), Food and
Drug Administration, 645 S. Newstead
Ave., St. Louis, MO 63110, 314–539–
2168; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Elemental Impurities in Drug
Products.’’ This draft guidance provides
recommendations regarding the control
of elemental impurities of human drug
products marketed in the United States
consistent with implementation of ICH
Q3D. The draft guidance will also assist
manufacturers of compendial drug
products in responding to the issuance
of the USP requirement for the control
of elemental impurities.
USP introduced new limits and
analytical procedures for elemental
impurities in General Chapters
Elemental Impurities—Limits and
Elemental Impurities—Procedures.
Their primary goals are to (1) set limits
for acceptable levels of elemental
impurities in finished drug products,
and (2) update the methodology used to
test for elemental impurities in drug
products to include modern analytical
procedures. ICH Q3D contains
recommendations for manufacturers of
human drugs and biologics on applying
a risk-based approach to control
elemental impurities and permitted
daily exposure. USP worked closely
with ICH to align its new General
Chapters with ICH Q3D.
Because elemental impurities pose
toxicological concerns and do not
provide any therapeutic benefit to the
patient, their levels in drug products
should be controlled within acceptable
limits. In general, FDA recommends that
the manufacturer of any U.S. marketed
drug product follow ICH Q3D
recommendations to establish
appropriate procedures for identifying
and controlling elemental impurities in
the drug product based on risk
assessment and product-specific
considerations, unless the drug product
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
must comply with USP–NF
requirements. This draft guidance
outlines approaches for implementation
of USP, and ICH Q3D in new and
existing products.
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 elemental impurities in drug
products. 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 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
part 314 for submitting NDAs and
ANDAs, including supplemental
applications and annual reports, have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 211 and part
212 (CGMPs) have been approved under
OMB control numbers 0910–0139 and
0910–0667.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.regulations.gov.
Dated: June 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–15704 Filed 6–30–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1662]
Vulvovaginal Candidiasis: Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\01JYN1.SGM
Notice.
01JYN1
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Vulvovaginal Candidiasis: Developing
Drugs for Treatment.’’ The purpose of
this guidance is to assist sponsors in the
clinical development of drugs for the
treatment of uncomplicated
vulvovaginal candidiasis (VVC).
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 29,
2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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’’).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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,
VerDate Sep<11>2014
19:05 Jun 30, 2016
Jkt 238001
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–1662 for ‘‘Vulvovaginal
Candidiasis: 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
https://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 https://
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: https://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 https://
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,
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
43213
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.
FOR FURTHER INFORMATION CONTACT:
Shrimant Mishra, 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.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Vulvovaginal Candidiasis: Developing
Drugs for Treatment.’’ The purpose of
this guidance is to assist sponsors in the
development of drugs for the treatment
of uncomplicated VVC.
This guidance helps define
enrollment criteria for VVC trials, and
recommends that such trials be
superiority trials against placebo or
active control. The recommended
efficacy endpoint is resolution of
clinical signs and symptoms. In
addition, this guidance reflects recent
developments in scientific information
that pertain to drugs being developed
for the treatment of VVC.
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 ‘‘Vulvovaginal Candidiasis:
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 2013 Federal
Register notice, FDA announced that
the 1998 draft guidance, as well as other
draft guidances, was being withdrawn
because new information, scientific
developments, and emerging
technologies required a revision. 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).
E:\FR\FM\01JYN1.SGM
01JYN1
43214
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
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 part 312 have
been approved under OMB control
number 0910–0014.
III. Electronic Access
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 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–15661 Filed 6–30–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Lists of Designated Primary Medical
Care, Mental Health, and Dental Health
Professional Shortage Areas
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
This notice advises the public
of the published lists of all geographic
areas, population groups, and facilities
designated as primary medical care,
mental health, and dental health
professional shortage areas (HPSAs) as
of May 13, 2016, available on the Health
Resources and Services Administration
(HRSA) Web site at https://
www.hrsa.gov/shortage/. HPSAs are
designated or withdrawn by the
Secretary of Health and Human Services
(HHS) under the authority of section
332 of the Public Health Service (PHS)
Act and 42 CFR part 5.
FOR FURTHER INFORMATION CONTACT:
Requests for further information on the
HPSA designations listed on the HRSA
Web site below should be submitted to
Kae Brickerd, Ph.D., Director, Shortage
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:05 Jun 30, 2016
Jkt 238001
Designation Branch, Division of Policy
and Shortage Designation, Bureau of
Health Workforce (BHW), HRSA, Mail
Stop 11SWH03, 5600 Fishers Lane,
Rockville, Maryland 20857, (301) 594–
5168 or KBrickerd@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Background
Section 332 of the PHS Act, 42 U.S.C.
254e, provides that the Secretary of HHS
shall designate HPSAs based on criteria
established by regulation. HPSAs are
defined in section 332 to include (1)
urban and rural geographic areas with
shortages of health professionals, (2)
population groups with such shortages,
and (3) facilities with such shortages.
Section 332 further requires that the
Secretary annually publish a list of the
designated geographic areas, population
groups, and facilities. HPSAs are to be
reviewed at least annually and revised
as necessary. HRSA’s BHW has the
responsibility for designating and
updating HPSAs.
Public or private nonprofit entities are
eligible to apply for assignment of
National Health Service Corps (NHSC)
personnel to provide primary care,
mental, or dental health services in or
to these HPSAs. NHSC health
professionals with a service obligation
may enter into service agreements to
serve only in federally designated
HPSAs. Entities with clinical training
sites located in HPSAs are eligible to
receive priority for certain residency
training program grants administered by
BHW. Many other federal programs also
utilize HPSA designations. For example,
under authorities administered by the
Centers for Medicare & Medicaid
Services, certain qualified providers in
geographic area HPSAs are eligible for
increased levels of Medicare
reimbursement.
Development of the Designation and
Withdrawal Lists
Criteria for designating HPSAs were
published as final regulations (42 CFR
part 5) in 1980. Criteria then were
defined for each of seven health
professional types (primary medical
care, dental, psychiatric, vision care,
podiatric, pharmacy, and veterinary
care). The criteria for correctional
facility HPSAs were revised and
published on March 2, 1989 (54 FR
8735). The criteria for psychiatric
HPSAs were expanded to mental health
HPSAs on January 22, 1992 (57 FR
2473). Currently funded PHS Act
programs use only the primary medical
care, mental health, or dental HPSA
designations.
Individual requests for designation or
withdrawal of a particular geographic
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
area, population group, or a facility as
a HPSA are received and reviewed
continuously by BHW. The majority of
the requests come from the Primary Care
Offices (PCO) in the State Health
Departments, who have access to the online application and review system.
Requests that come from other sources
are referred to the PCOs for their review
and concurrence. In addition, interested
parties, including the Governor, the
State Primary Care Association and state
professional associations are notified of
each request submitted for their
comments and recommendations.
Recommendations for possible
additions, continuations, revisions, or
withdrawals from a HPSA list are
reviewed by BHW, and the review
findings are provided by letter to the
agency or individual requesting action
or providing data, with copies to other
interested organizations and
individuals. These letters constitute the
official notice of designation as a HPSA,
rejection of recommendations for HPSA
designation, revision of a HPSA
designation, and/or advance notice of
pending withdrawals from the HPSA
list. Designations (or revisions of
designations) are effective as of the date
on the notification letter from BHW.
Proposed withdrawals become effective
only after interested parties in the area
affected have been afforded the
opportunity to submit additional
information to BHW in support of its
continued or revised designation. If no
new data are submitted, or if BHW
review confirms the proposed
withdrawal, the withdrawal becomes
effective upon publication of the lists of
designated HPSAs in the Federal
Register. In addition, lists of HPSAs are
updated daily on the HRSA Web site,
https://www.hrsa.gov/shortage/, so that
interested parties can access the most
accurate and timely information.
Publication and Format of Lists
Due to the large volume of
designations, a printed version of the
list is no longer distributed. This notice
serves to inform the public of the
availability of the complete listings of
designated HPSAs on the HRSA Web
site. The three lists (primary medical
care, mental health, and dental) of
designated HPSAs are available at a link
on the HRSA Web site at https://
www.hrsa.gov/shortage/ and include a
snapshot of all geographic areas,
population groups, and facilities that
were designated HPSAs as of May 13,
2016. This notice incorporates the most
recent annual reviews of designated
HPSAs and supersedes the HPSA lists
published in the Federal Register on
July 1, 2015 (Federal Register/Vol. 80,
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43212-43214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15661]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1662]
Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 43213]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Vulvovaginal Candidiasis: Developing Drugs for Treatment.'' The
purpose of this guidance is to assist sponsors in the clinical
development of drugs for the treatment of uncomplicated vulvovaginal
candidiasis (VVC).
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 29, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-1662 for ``Vulvovaginal Candidiasis: 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 https://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 https://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: https://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 https://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.
FOR FURTHER INFORMATION CONTACT: Shrimant Mishra, 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.
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Vulvovaginal Candidiasis: Developing Drugs for Treatment.''
The purpose of this guidance is to assist sponsors in the development
of drugs for the treatment of uncomplicated VVC.
This guidance helps define enrollment criteria for VVC trials, and
recommends that such trials be superiority trials against placebo or
active control. The recommended efficacy endpoint is resolution of
clinical signs and symptoms. In addition, this guidance reflects recent
developments in scientific information that pertain to drugs being
developed for the treatment of VVC.
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
``Vulvovaginal Candidiasis: 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 2013 Federal Register
notice, FDA announced that the 1998 draft guidance, as well as other
draft guidances, was being withdrawn because new information,
scientific developments, and emerging technologies required a revision.
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).
[[Page 43214]]
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 part 312 have been
approved under OMB control number 0910-0014.
III. 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 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15661 Filed 6-30-16; 8:45 am]
BILLING CODE 4164-01-P
