81 FR 69535 - Head Lice Infestation: Developing Drugs for Topical Treatment; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 194 (October 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 194 (October 6, 2016)
| Page Range | 69535-69537 | |
| FR Document | 2016-24233 |
[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)] [Notices] [Pages 69535-69537] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24233] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4561] Head Lice Infestation: Developing Drugs for Topical Treatment; 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 guidance for industry entitled ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information [[Page 69536]] presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials. This guidance finalizes the draft guidance of the same name issued on December 15, 2015. DATES: Submit either electronic or written comments on Agency guidances at any time. 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-2015-D-4561 for ``Head Lice infestation: Developing Drugs for Topical Treatment.'' 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 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. FOR FURTHER INFORMATION CONTACT: Strother D. Dixon, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301- 796-1015. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials. This guidance finalizes the draft guidance of the same name issued on December 15, 2015 (80 FR 77636). No changes were made from the draft guidance. 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 topical treatment of head lice infestation. 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. The collections of information for prescription drug product labeling in 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910-0572. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. [[Page 69537]] Dated: September 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-24233 Filed 10-5-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices 69535
and volume of solvent used for meeting will be available at http:// Meeting’’ if you make your reservation
extraction? www.fda.gov/Drugs/NewsEvents/ by calling 1–800–676–6137, or book
• How can FDA standardize in vitro ucm509853.htm following the meeting. your reservation at http://
testing to help substantiate appropriate FDA has verified the Web site www.marriott.com/meeting-event-
and consistent product manufacture that addresses, as of the date this document hotels/group-corporate-travel/
assures abuse deterrence at release and publishes in the Federal Register, but groupCorp.mi?resLinkData
through a drug product’s shelf life? Web sites are subject to change over =FDA%20Opioid%20Drug%20Meeting
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measured by in vitro testing be Requests for Oral Presentations: If you GA%60231.00%60USD%60
quantified and linked to their impact on wish to present at the public meeting, false%602%6010/30/16%6011/1/
abuse deterrence? For example, discuss you must register and indicate which 16%6010/12/16&app=resvlink&stop_
what amount of time delay in defeating topic(s) you wish to address: approach mobi=yes.
an abuse-deterrent property should be to testing FDA recommended in its draft If you need special accommodations
considered significant and the basis for guidance ‘‘General Principles for because of a disability, please contact
the recommendation. Evaluating the Abuse Deterrence of La’Shaune Morant, 240–316–3206,
• How can FDA build flexibility into Generic Solid Oral Opioid Drug lashaune@tepgevents.com no later than
standardized testing so that it may be Products,’’ new technologies for October 12, 2016.
suitable for application to emerging deterring abuse of oral opioid drug
technologies? Are there any specific III. Transcript Request
products, or standardization of in vitro
emerging technologies that might testing methodologies for evaluating Transcripts of the meeting will be
require new types of testing? purportedly abuse-deterrent available for review at the Division of
formulations of opioid drug products. Dockets Management (HFA–305), Food
II. Registration and Accommodations and Drug Administration, 5630 Fishers
This will help FDA organize the
Registration: Registration is free and presentations. FDA will do its best to Lane, Rm. 1061, Rockville, MD 20850,
available on a first-come, first-served accommodate requests to make public and on the Internet at http://
basis. Persons interested in attending comments. Individuals and www.regulations.gov approximately 30
this public meeting must register by organizations with common interests are days after the meeting. A transcript will
close of business on October 17, 2016. urged to consolidate or coordinate their also be available in either hard copy or
If you need special accommodations presentations, and request time for a on CD–ROM, after submission of a
because of a disability, please contact joint presentation. Following the close Freedom of Information request. The
La’Shaune Morant, 240–316–3206, of the registration, FDA will determine Freedom of Information office address is
email: lashaune@tepgevents.com no the amount of time allotted to each available on the Agency’s Web site at
later than October 12, 2016. presenter and the approximate time http://www.fda.gov.
To register for the public meeting, each oral presentation is to begin, and Dated: September 30, 2016.
please visit http://www.cvent.com/d/ will select and notify participants by Leslie Kux,
wvq0sm/4W (FDA has verified the Web October 24, 2016. All requests to make
address, but FDA is not responsible for Associate Commissioner for Policy.
oral presentations must be received by
subsequent changes to the Web site after [FR Doc. 2016–24234 Filed 10–5–16; 8:45 am]
the close of registration, October 17,
this document publishes in the Federal 2016. If you are selected, any BILLING CODE 4164–01–P
Register) by October 17, 2016. Those presentation materials must be emailed
without Internet access may register by to Michelle Eby (see FOR FURTHER
contacting La’Shaune Morant, 240–316– DEPARTMENT OF HEALTH AND
INFORMATION CONTACT) no later than
3206. Early registration is recommended HUMAN SERVICES
October 27, 2016. No commercial or
because facilities are limited and, promotional material will be permitted Food and Drug Administration
therefore, FDA may limit the number of to be presented or distributed at the
participants from each organization. public meeting. [Docket No. FDA–2015–D–4561]
You will receive confirmation after you FDA is holding this public meeting to
have registered and been accepted or Head Lice Infestation: Developing
obtain information on scientific and
you will be notified if you are on a technical issues relating to formulation Drugs for Topical Treatment; Guidance
waiting list. FDA may allow onsite development and pre-market evaluation for Industry; Availability
registration if space is available. If of opioid drug products with abuse- AGENCY: Food and Drug Administration,
registration reaches maximum capacity, deterrent properties. In order to permit HHS.
FDA will post a notice closing the widest possible opportunity for ACTION: Notice of availability.
registration at http://www.fda.gov/ public comment, FDA is soliciting
Drugs/NewsEvents/ucm509853.htm. either electronic or written comments SUMMARY: The Food and Drug
Streaming Webcast of the Public on all aspects of the public meeting Administration (FDA or Agency) is
Meeting: The meeting will also be topics. The deadline for submitting announcing the availability of a
Webcast. Persons interested in viewing comments related to this public meeting guidance for industry entitled ‘‘Head
the Webcast must register online by is December 1, 2016. Lice Infestation: Developing Drugs for
October 17, 2016. Early registration is Accommodations: Attendees are Topical Treatment.’’ The purpose of this
recommended because Webcast responsible for their own hotel guidance is to assist sponsors in the
connections may be limited. accommodations. Attendees making clinical development of drugs for the
sradovich on DSK3GMQ082PROD with NOTICES
Organizations are requested to register reservations at the College Park Marriott treatment of head lice infestation. This
all participants, but to view using one Hotel and Conference Center, 3501 guidance addresses the Agency’s current
connection per location. A link to the University Blvd. East, Hyattsville, MD thinking regarding the overall
live Webcast will be available at http:// 20783, are eligible for a reduced rate of development program and clinical trial
www.fda.gov/Drugs/NewsEvents/ $231/night, not including applicable designs of drugs to support approval of
ucm509853.htm on the day of the public taxes. To receive the reduced rate, an indication for topical treatment of
meeting. A video record of the public please reference ‘‘FDA Opioid Drug head lice infestation. The information
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![Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices 69537
Dated: September 30, 2016. that if you include your name, contact will not be disclosed except in
Leslie Kux, information, or other information that accordance with 21 CFR 10.20 and other
Associate Commissioner for Policy. identifies you in the body of your applicable disclosure law. For more
[FR Doc. 2016–24233 Filed 10–5–16; 8:45 am] comments, that information will be information about FDA’s posting of
BILLING CODE 4164–01–P posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND do not wish to be made available to the regulatoryinformation/dockets/
HUMAN SERVICES public, submit the comment as a default.htm.
written/paper submission and in the Docket: For access to the docket to
Food and Drug Administration manner detailed (see ‘‘Written/Paper read background documents or the
[Docket No. FDA–2008–D–0530]
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Written/Paper Submissions received, go to http://
Tropical Disease Priority Review www.regulations.gov and insert the
Vouchers; Guidance for Industry; Submit written/paper submissions as docket number, found in brackets in the
Availability follows: heading of this document, into the
• Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, written/paper submissions): Division of
and/or go to the Division of Dockets
HHS. Dockets Management (HFA–305), Food
Management, 5630 Fishers Lane, Rm.
ACTION: Notice of availability. and Drug Administration, 5630 Fishers
1061, Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single
SUMMARY: The Food and Drug • For written/paper comments
Administration (FDA or Agency) is submitted to the Division of Dockets copies of this guidance to the Division
announcing the availability of a Management, FDA will post your of Drug Information, Center for Drug
guidance for industry entitled ‘‘Tropical comment, as well as any attachments, Evaluation and Research, Food and
Disease Priority Review Vouchers.’’ except for information submitted, Drug Administration, 10001 New
There has been significant outside marked and identified, as confidential, Hampshire Ave., Hillandale Building,
interest in FDA’s interpretation of the if submitted as detailed in 4th Floor, Silver Spring, MD 20993–
priority review voucher section in the ‘‘Instructions.’’ 0002, or the Office of Communication,
Federal Food, Drug, and Cosmetic Act Instructions: All submissions received Outreach and Development, Center for
(the FD&C Act) added by the Food and must include the Docket No. FDA– Biologics Evaluation and Research,
Drug Administration Amendments Act 2008–D–0530 for Tropical Disease Food and Drug Administration, 10903
(FDAAA). This section makes Priority Review Vouchers; Guidance for New Hampshire Ave., Bldg. 71, Rm.
provisions for awarding priority review Industry; Availability. Received 3128, Silver Spring, MD 20993–0002.
vouchers for future applications to comments will be placed in the docket Send one self-addressed adhesive label
sponsors of tropical disease product and, except for those submitted as to assist that office in processing your
applications that meet the criteria ‘‘Confidential Submissions,’’ publicly requests. See the SUPPLEMENTARY
specified by the FD&C Act. This viewable at http://www.regulations.gov INFORMATION section for electronic
guidance explains to internal and or at the Division of Dockets access to the guidance document.
external stakeholders how FDA is Management between 9 a.m. and 4 p.m., FOR FURTHER INFORMATION CONTACT:
implementing the provisions of this Monday through Friday. Katherine Schumann, Center for Drug
section. This guidance finalizes the draft • Confidential Submissions—To Evaluation and Research, Food and
guidance of the same name issued submit a comment with confidential Drug Administration, 10903 New
October 2008. information that you do not wish to be Hampshire Ave., Bldg. 22, Rm. 6360,
DATES: Submit either electronic or made publicly available, submit your Silver Spring, MD 20993–0002, 301–
written comments on Agency guidances comments only as a written/paper 796–1182; or Stephen Ripley, Center for
at any time. submission. You should submit two Biologics Evaluation and Research,
ADDRESSES: You may submit comments copies total. One copy will include the Food and Drug Administration, 10903
as follows: information you claim to be confidential New Hampshire Ave., Bldg. 71, Rm.
with a heading or cover note that states 3128, Silver Spring, MD 20993–0002,
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS 240–402–7911.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
following way: Agency will review this copy, including
• Federal eRulemaking Portal: http:// the claimed confidential information, in I. Background
www.regulations.gov. Follow the its consideration of comments. The FDA is announcing the availability of
instructions for submitting comments. second copy, which will have the a guidance for industry entitled
Comments submitted electronically, claimed confidential information ‘‘Tropical Disease Priority Review
including attachments, to http:// redacted/blacked out, will be available Vouchers.’’ Section 1102 of FDAAA
www.regulations.gov will be posted to for public viewing and posted on http:// added section 524 to the FD&C Act.
the docket unchanged. Because your www.regulations.gov. Submit both Section 524 is designed to encourage
comment will be made public, you are copies to the Division of Dockets development of new drug or biological
solely responsible for ensuring that your Management. If you do not wish your products for prevention and treatment
sradovich on DSK3GMQ082PROD with NOTICES
comment does not include any name and contact information to be of certain tropical diseases affecting
confidential information that you or a made publicly available, you can millions of people throughout the
third party may not wish to be posted, provide this information on the cover world. By enacting section 524,
such as medical information, your or sheet and not in the body of your Congress intended to stimulate new
anyone else’s Social Security number, or comments and you must identify this drug development for drug products to
confidential business information, such information as ‘‘confidential.’’ Any treat certain tropical diseases by offering
as a manufacturing process. Please note information marked as ‘‘confidential’’ additional incentives for obtaining FDA
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Document Created: 2016-10-06 02:38:01
Document Modified: 2016-10-06 02:38:01
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Strother D. Dixon, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301- 796-1015. | |
| FR Citation | 81 FR 69535 |
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