81 FR 43212 - Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 127 (July 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43212-43214 | |
| FR Document | 2016-15661 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43212-43214] From the Federal Register Online [www.thefederalregister.org] [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Food and Drug Administration [Docket No. FDA-2016-D-1662] Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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[[Page 43213]] SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Vulvovaginal Candidiasis: Developing Drugs for Treatment.''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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 29, 2016.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: 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-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 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. 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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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
![43212 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
Instructions: All submissions received Food and Drug Administration, 10903 must comply with USP–NF
must include the Docket No. FDA– New Hampshire Ave., Bldg. 71, Rm. requirements. This draft guidance
2016–D–1692 for Elemental Impurities 3128, Silver Spring, MD 20993–0002. outlines approaches for implementation
in Drug Products. Received comments Send one self-addressed adhesive label of USP, and ICH Q3D in new and
will be placed in the docket and, except to assist that office in processing your existing products.
for those submitted as ‘‘Confidential requests. See the SUPPLEMENTARY This draft guidance is being issued
Submissions,’’ publicly viewable at INFORMATION section for electronic consistent with FDA’s good guidance
http://www.regulations.gov or at the access to the draft guidance document. practices regulation (21 CFR 10.115).
Division of Dockets Management FOR FURTHER INFORMATION CONTACT: John The draft guidance, when finalized, will
between 9 a.m. and 4 p.m., Monday Kauffman, Center for Drug Evaluation represent the current thinking of FDA
through Friday. and Research (HFD–920), Food and on elemental impurities in drug
• Confidential Submissions—To Drug Administration, 645 S. Newstead products. It does not establish any rights
submit a comment with confidential Ave., St. Louis, MO 63110, 314–539– for any person and is not binding on
information that you do not wish to be 2168; or Stephen Ripley, Center for FDA or the public. You can use an
made publicly available, submit your Biologics Evaluation and Research, alternative approach if it satisfies the
comments only as a written/paper Food and Drug Administration, 10903 requirements of the applicable statutes
submission. You should submit two New Hampshire Ave., Bldg. 71, Rm. and regulations.
copies total. One copy will include the 7301, Silver Spring, MD 20993–0002,
information you claim to be confidential II. The Paperwork Reduction Act of
240–402–7911. 1995
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS SUPPLEMENTARY INFORMATION:
This draft guidance refers to
CONFIDENTIAL INFORMATION’’. The I. Background previously approved collections of
Agency will review this copy, including information that are subject to review by
FDA is announcing the availability of
the claimed confidential information, in the Office of Management and Budget
its consideration of comments. The a draft guidance for industry entitled
‘‘Elemental Impurities in Drug (OMB) under the Paperwork Reduction
second copy, which will have the Act of 1995 (44 U.S.C. 3501–3520). The
claimed confidential information Products.’’ This draft guidance provides
recommendations regarding the control collections of information in 21 CFR
redacted/blacked out, will be available part 314 for submitting NDAs and
for public viewing and posted on http:// of elemental impurities of human drug
products marketed in the United States ANDAs, including supplemental
www.regulations.gov. Submit both applications and annual reports, have
copies to the Division of Dockets consistent with implementation of ICH
Q3D. The draft guidance will also assist been approved under OMB control
Management. If you do not wish your number 0910–0001. The collections of
name and contact information to be manufacturers of compendial drug
products in responding to the issuance information in 21 CFR part 211 and part
made publicly available, you can 212 (CGMPs) have been approved under
provide this information on the cover of the USP requirement for the control
of elemental impurities. OMB control numbers 0910–0139 and
sheet and not in the body of your 0910–0667.
comments and you must identify this USP introduced new limits and
information as ‘‘confidential.’’ Any analytical procedures for elemental III. Electronic Access
information marked as ‘‘confidential’’ impurities in General Chapters
Elemental Impurities—Limits and Persons with access to the Internet
will not be disclosed except in may obtain the document at http://www.
accordance with 21 CFR 10.20 and other Elemental Impurities—Procedures.
Their primary goals are to (1) set limits fda.gov/Drugs/GuidanceCompliance
applicable disclosure law. For more RegulatoryInformation/Guidances/
information about FDA’s posting of for acceptable levels of elemental
impurities in finished drug products, default.htm, http://www.fda.gov/
comments to public dockets, see 80 FR BiologicsBloodVaccines/Guidance
56469, September 18, 2015, or access and (2) update the methodology used to
test for elemental impurities in drug ComplianceRegulatoryInformation/
the information at: http://www.fda.gov/ Guidances/default.htm, or http://
regulatoryinformation/dockets/ products to include modern analytical
procedures. ICH Q3D contains www.regulations.gov.
default.htm.
Docket: For access to the docket to recommendations for manufacturers of Dated: June 27, 2016.
read background documents or the human drugs and biologics on applying Leslie Kux,
electronic and written/paper comments a risk-based approach to control Associate Commissioner for Policy.
received, go to http:// elemental impurities and permitted [FR Doc. 2016–15704 Filed 6–30–16; 8:45 am]
www.regulations.gov and insert the daily exposure. USP worked closely BILLING CODE 4164–01–P
docket number, found in brackets in the with ICH to align its new General
heading of this document, into the Chapters with ICH Q3D.
‘‘Search’’ box and follow the prompts Because elemental impurities pose DEPARTMENT OF HEALTH AND
and/or go to the Division of Dockets toxicological concerns and do not HUMAN SERVICES
Management, 5630 Fishers Lane, Rm. provide any therapeutic benefit to the
1061, Rockville, MD 20852. patient, their levels in drug products Food and Drug Administration
Submit written requests for single should be controlled within acceptable
copies of the draft guidance to the limits. In general, FDA recommends that [Docket No. FDA–2016–D–1662]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Division of Drug Information, Center for the manufacturer of any U.S. marketed
Drug Evaluation and Research, Food drug product follow ICH Q3D Vulvovaginal Candidiasis: Developing
and Drug Administration, 10001 New recommendations to establish Drugs for Treatment; Draft Guidance
Hampshire Ave., Hillandale Building, appropriate procedures for identifying for Industry; Availability
4th Floor, Silver Spring, MD 20993– and controlling elemental impurities in AGENCY: Food and Drug Administration,
0002; or the Office of Communication, the drug product based on risk HHS.
Outreach and Development, Center for assessment and product-specific
ACTION: Notice.
Biologics Evaluation and Research, considerations, unless the drug product
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![43214 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
The draft guidance, when finalized, will Designation Branch, Division of Policy area, population group, or a facility as
represent the current thinking of FDA and Shortage Designation, Bureau of a HPSA are received and reviewed
on this topic. It does not establish any Health Workforce (BHW), HRSA, Mail continuously by BHW. The majority of
rights for any person and is not binding Stop 11SWH03, 5600 Fishers Lane, the requests come from the Primary Care
on FDA or the public. You can use an Rockville, Maryland 20857, (301) 594– Offices (PCO) in the State Health
alternative approach if it satisfies the 5168 or KBrickerd@hrsa.gov. Departments, who have access to the on-
requirements of the applicable statutes SUPPLEMENTARY INFORMATION: line application and review system.
and regulations. Requests that come from other sources
Background are referred to the PCOs for their review
II. The Paperwork Reduction Act of Section 332 of the PHS Act, 42 U.S.C. and concurrence. In addition, interested
1995 254e, provides that the Secretary of HHS parties, including the Governor, the
This guidance refers to previously shall designate HPSAs based on criteria State Primary Care Association and state
approved collections of information that established by regulation. HPSAs are professional associations are notified of
are subject to review by the Office of defined in section 332 to include (1) each request submitted for their
Management and Budget (OMB) under urban and rural geographic areas with comments and recommendations.
the Paperwork Reduction Act of 1995 shortages of health professionals, (2) Recommendations for possible
(44 U.S.C. 3501–3520). The collections population groups with such shortages, additions, continuations, revisions, or
of information in 21 CFR part 312 have and (3) facilities with such shortages. withdrawals from a HPSA list are
been approved under OMB control Section 332 further requires that the reviewed by BHW, and the review
number 0910–0014. Secretary annually publish a list of the findings are provided by letter to the
designated geographic areas, population agency or individual requesting action
III. Electronic Access groups, and facilities. HPSAs are to be or providing data, with copies to other
Persons with access to the Internet reviewed at least annually and revised interested organizations and
may obtain the document at either as necessary. HRSA’s BHW has the individuals. These letters constitute the
http://www.fda.gov/Drugs/Guidance responsibility for designating and official notice of designation as a HPSA,
ComplianceRegulatoryInformation/ updating HPSAs. rejection of recommendations for HPSA
Guidances/default.htm or http:// Public or private nonprofit entities are designation, revision of a HPSA
www.regulations.gov. eligible to apply for assignment of designation, and/or advance notice of
Dated: June 27, 2016. National Health Service Corps (NHSC) pending withdrawals from the HPSA
Leslie Kux,
personnel to provide primary care, list. Designations (or revisions of
mental, or dental health services in or designations) are effective as of the date
Associate Commissioner for Policy.
to these HPSAs. NHSC health on the notification letter from BHW.
[FR Doc. 2016–15661 Filed 6–30–16; 8:45 am] professionals with a service obligation Proposed withdrawals become effective
BILLING CODE 4164–01–P may enter into service agreements to only after interested parties in the area
serve only in federally designated affected have been afforded the
HPSAs. Entities with clinical training opportunity to submit additional
DEPARTMENT OF HEALTH AND sites located in HPSAs are eligible to information to BHW in support of its
HUMAN SERVICES receive priority for certain residency continued or revised designation. If no
training program grants administered by new data are submitted, or if BHW
Health Resources and Services
BHW. Many other federal programs also review confirms the proposed
Administration
utilize HPSA designations. For example, withdrawal, the withdrawal becomes
Lists of Designated Primary Medical under authorities administered by the effective upon publication of the lists of
Care, Mental Health, and Dental Health Centers for Medicare & Medicaid designated HPSAs in the Federal
Professional Shortage Areas Services, certain qualified providers in Register. In addition, lists of HPSAs are
geographic area HPSAs are eligible for updated daily on the HRSA Web site,
AGENCY: Health Resources and Services increased levels of Medicare http://www.hrsa.gov/shortage/, so that
Administration, HHS. reimbursement. interested parties can access the most
ACTION: Notice. accurate and timely information.
Development of the Designation and
SUMMARY: This notice advises the public Withdrawal Lists Publication and Format of Lists
of the published lists of all geographic Criteria for designating HPSAs were Due to the large volume of
areas, population groups, and facilities published as final regulations (42 CFR designations, a printed version of the
designated as primary medical care, part 5) in 1980. Criteria then were list is no longer distributed. This notice
mental health, and dental health defined for each of seven health serves to inform the public of the
professional shortage areas (HPSAs) as professional types (primary medical availability of the complete listings of
of May 13, 2016, available on the Health care, dental, psychiatric, vision care, designated HPSAs on the HRSA Web
Resources and Services Administration podiatric, pharmacy, and veterinary site. The three lists (primary medical
(HRSA) Web site at http:// care). The criteria for correctional care, mental health, and dental) of
www.hrsa.gov/shortage/. HPSAs are facility HPSAs were revised and designated HPSAs are available at a link
designated or withdrawn by the published on March 2, 1989 (54 FR on the HRSA Web site at http://
Secretary of Health and Human Services 8735). The criteria for psychiatric www.hrsa.gov/shortage/ and include a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
(HHS) under the authority of section HPSAs were expanded to mental health snapshot of all geographic areas,
332 of the Public Health Service (PHS) HPSAs on January 22, 1992 (57 FR population groups, and facilities that
Act and 42 CFR part 5. 2473). Currently funded PHS Act were designated HPSAs as of May 13,
FOR FURTHER INFORMATION CONTACT: programs use only the primary medical 2016. This notice incorporates the most
Requests for further information on the care, mental health, or dental HPSA recent annual reviews of designated
HPSA designations listed on the HRSA designations. HPSAs and supersedes the HPSA lists
Web site below should be submitted to Individual requests for designation or published in the Federal Register on
Kae Brickerd, Ph.D., Director, Shortage withdrawal of a particular geographic July 1, 2015 (Federal Register/Vol. 80,
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Document Created: 2016-07-14 11:37:54
Document Modified: 2016-07-14 11:37:54
| 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. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 43212 |
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