80 FR 77636 - Head Lice Infestation: Developing Drugs for Topical Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 240 (December 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77636-77637 | |
| FR Document | 2015-31406 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Notices] [Pages 77636-77637] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31406] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4561] Head Lice Infestation: Developing Drugs for Topical Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This draft guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for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. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 14, 2016.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-2015-D-4561 for ``Head Lice Infestation: Developing Drugs for Topical 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 Bldg., 4th Floor, Silver Spring, MD 20993. 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: Strother D. Dixon, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5168, [[Page 77637]] Silver Spring, MD 20993-0002, 301-796-1015. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This draft 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 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 developing drugs for the 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 document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: December 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31406 Filed 12-14-15; 8:45 am] BILLING CODE 4164-01-P
![77636 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
number 1400049 to identify the considers your comment on this draft Management between 9 a.m. and 4 p.m.,
guidance you are requesting. guidance before it begins work on the Monday through Friday.
final version of the guidance, submit • Confidential Submissions: To
IV. Paperwork Reduction Act of 1995
either electronic or written comments submit a comment with confidential
The guidance document ‘‘Premarket on the draft guidance by March 14, information that you do not wish to be
Studies of Implantable Minimally 2016. made publicly available, submit your
Invasive Glaucoma Surgical (MIGS) comments only as a written/paper
ADDRESSES: You may submit comments
Devices’’ refers to previously approved submission. You should submit two
as follows:
information collections found in FDA copies total. One copy will include the
regulations and guidance. These Electronic Submissions information you claim to be confidential
collections of information are subject to Submit electronic comments in the with a heading or cover note that states
review by the Office of Management and following way: ‘‘THIS DOCUMENT CONTAINS
Budget (OMB) under the Paperwork • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
Reduction Act of 1995 (44 U.S.C. 3501– www.regulations.gov. Follow the Agency will review this copy, including
3520). The collections of information in instructions for submitting comments. the claimed confidential information, in
21 CFR part 814, subparts B and E are Comments submitted electronically, its consideration of comments. The
approved under OMB control number including attachments, to http:// second copy, which will have the
0910–0231 and the collections of www.regulations.gov will be posted to claimed confidential information
information in the guidance document the docket unchanged. Because your redacted/blacked out, will be available
entitled ‘‘Requests for Feedback on comment will be made public, you are for public viewing and posted on
Medical Device Submissions: The Pre- solely responsible for ensuring that your http://www.regulations.gov. Submit
Submission Program and Meetings with comment does not include any both copies to the Division of Dockets
Food and Drug Administration Staff’’ confidential information that you or a Management. If you do not wish your
are approved under OMB control third party may not wish to be posted, name and contact information to be
number 0910–0756. such as medical information, your or made publicly available, you can
Dated: December 8, 2015. anyone else’s Social Security number, or provide this information on the cover
Leslie Kux, confidential business information, such sheet and not in the body of your
Associate Commissioner for Policy. as a manufacturing process. Please note comments and you must identify this
[FR Doc. 2015–31407 Filed 12–14–15; 8:45 am] that if you include your name, contact information as ‘‘confidential.’’ Any
BILLING CODE 4164–01–P
information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
DEPARTMENT OF HEALTH AND posted on http://www.regulations.gov. applicable disclosure law. For more
HUMAN SERVICES • If you want to submit a comment information about FDA’s posting of
with confidential information that you comments to public dockets, see 80 FR
Food and Drug Administration do not wish to be made available to the 56469, September 18, 2015, or access
[Docket No. FDA–2015–D–4561] public, submit the comment as a the information at: http://www.fda.gov/
written/paper submission and in the regulatoryinformation/dockets/
Head Lice Infestation: Developing manner detailed (see ‘‘Written/Paper default.htm.
Drugs for Topical Treatment; Draft Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Guidance for Industry; Availability Written/Paper Submissions read background documents or the
electronic and written/paper comments
AGENCY: Food and Drug Administration, Submit written/paper submissions as received, go to http://
HHS. follows: www.regulations.gov and insert the
ACTION: Notice of availability. • Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Division of heading of this document, into the
SUMMARY: The Food and Drug Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
Administration (FDA) is announcing the and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
availability of a draft guidance for Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
industry entitled ‘‘Head Lice Infestation: • For written/paper comments 1061, Rockville, MD 20852.
Developing Drugs for Topical submitted to the Division of Dockets
Treatment.’’ The purpose of this draft Submit written requests for single
Management, FDA will post your
guidance is to assist sponsors in the copies of the draft guidance to the
comment, as well as any attachments,
clinical development of drugs for the Division of Drug Information, Center for
except for information submitted,
treatment of head lice infestation. This Drug Evaluation and Research, Food
marked and identified, as confidential,
draft guidance addresses the Agency’s and Drug Administration, 10001 New
if submitted as detailed in
current thinking regarding the overall Hampshire Ave., Hillandale Bldg., 4th
‘‘Instructions.’’
development program and clinical trial Floor, Silver Spring, MD 20993. Send
Instructions: All submissions received
designs of drugs to support approval of one self-addressed adhesive label to
must include the Docket No. FDA–
an indication for topical treatment of assist that office in processing your
2015–D–4561 for ‘‘Head Lice
asabaliauskas on DSK5VPTVN1PROD with NOTICES
head lice infestation. The information requests. See the SUPPLEMENTARY
Infestation: Developing Drugs for
presented will help sponsors plan INFORMATION section for electronic
Topical Treatment; Draft Guidance for
clinical trials, design clinical protocols, Industry; Availability.’’ Received access to the draft guidance document.
and conduct and appropriately monitor comments will be placed in the docket FOR FURTHER INFORMATION CONTACT:
clinical trials. and, except for those submitted as Strother D. Dixon, Center for Drug
DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly Evaluation and Research, Food and
any guidance at any time (see 21 CFR viewable at http://www.regulations.gov Drug Administration, 10903 New
10.115(g)(5)), to ensure that the Agency or at the Division of Dockets Hampshire Ave., Bldg. 22, Rm. 5168,
VerDate Sep<11>2014 17:08 Dec 14, 2015 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\15DEN1.SGM 15DEN1](https://thefederalregister.org/doc/80_FR_77876/page/1.svg)
![Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices 77637
Silver Spring, MD 20993–0002, 301– DEPARTMENT OF HEALTH AND Written/Paper Submissions
796–1015. HUMAN SERVICES Submit written/paper submissions as
SUPPLEMENTARY INFORMATION: follows:
Food and Drug Administration • Mail/Hand delivery/Courier (for
I. Background [Docket No. FDA–2012–0873] written/paper submissions): Division of
FDA is announcing the availability of Dockets Management (HFA–305), Food
Agency Information Collection and Drug Administration, 5630 Fishers
a draft guidance for industry entitled Activities; Proposed Collection;
‘‘Head Lice Infestation: Developing Lane, Rm. 1061, Rockville, MD 20852.
Comment Request; Bar Code Label • For written/paper comments
Drugs for Topical Treatment.’’ The Requirement for Human Drug and submitted to the Division of Dockets
purpose of this draft guidance is to Biological Products Management, FDA will post your
assist sponsors in the clinical
AGENCY: Food and Drug Administration, comment, as well as any attachments,
development of drugs for the treatment
HHS. except for information submitted,
of head lice infestation. This draft
ACTION: Notice. marked and identified, as confidential,
guidance addresses the Agency’s current
if submitted as detailed in
thinking regarding the overall
SUMMARY: The Food and Drug ‘‘Instructions.’’
development program and clinical trial
Administration (FDA) is announcing an Instructions: All submissions received
designs of drugs to support approval of
opportunity for public comment on the must include the Docket No. FDA–
an indication for topical treatment of
proposed collection of certain 2012–N–0873 for ‘‘Agency Information
head lice infestation. The information
information by the Agency. Under the Collection Activities: Proposed
presented will help sponsors plan
Paperwork Reduction Act of 1995 (the Collection; Comment Request; Bar Code
clinical trials, design clinical protocols,
PRA), Federal Agencies are required to Label Requirement for Human Drug and
and conduct and appropriately monitor
publish notice in the Federal Register Biological Products’’. Received
clinical trials.
concerning each proposed collection of comments will be placed in the docket
This draft guidance is being issued information, including each proposed and, except for those submitted as
consistent with FDA’s good guidance extension of an existing collection of ‘‘Confidential Submissions,’’ publicly
practices regulation (21 CFR 10.115). information, and to allow 60 days for viewable at
The draft guidance, when finalized, will public comment in response to the http://www.regulations.gov or at the
represent the current thinking of FDA notice. This notice solicits comments on Division of Dockets Management
on developing drugs for the topical the bar code label requirements for between 9 a.m. and 4 p.m., Monday
treatment of head lice infestation. It human drug and biological products. through Friday.
does not establish any rights for any DATES: Submit either electronic or • Confidential Submissions—To
person and is not binding on FDA or the written comments on the collection of submit a comment with confidential
public. You can use an alternative information by February 16, 2016. information that you do not wish to be
approach if it satisfies the requirements made publicly available, submit your
ADDRESSES: You may submit comments
of the applicable statutes and comments only as a written/paper
as follows:
regulations. submission. You should submit two
Electronic Submissions copies total. One copy will include the
II. The Paperwork Reduction Act of
1995 Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
This guidance refers to previously • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
approved collections of information that www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
are subject to review by the Office of instructions for submitting comments. Agency will review this copy, including
Management and Budget (OMB) under Comments submitted electronically, the claimed confidential information, in
the Paperwork Reduction Act of 1995 including attachments, to http:// its consideration of comments. The
(44 U.S.C. 3501–3520). The collections www.regulations.gov will be posted to second copy, which will have the
of information in 21 CFR parts 312 and the docket unchanged. Because your claimed confidential information
314 have been approved under OMB comment will be made public, you are redacted/blacked out, will be available
control numbers 0910–0014 and 0910– solely responsible for ensuring that your for public viewing and posted on http://
0001, respectively. The collections of comment does not include any www.regulations.gov. Submit both
information for prescription drug confidential information that you or a copies to the Division of Dockets
product labeling in 21 CFR 201.56 and third party may not wish to be posted, Management. If you do not wish your
201.57 have been approved under OMB such as medical information, your or name and contact information to be
control number 0910–0572. anyone else’s Social Security number, or made publicly available, you can
confidential business information, such provide this information on the cover
III. Electronic Access sheet and not in the body of your
as a manufacturing process. Please note
Persons with access to the Internet that if you include your name, contact comments and you must identify this
may obtain the document at either information, or other information that information as ‘‘confidential.’’ Any
http://www.fda.gov/Drugs/Guidance identifies you in the body of your information marked as ‘‘confidential’’
comments, that information will be will not be disclosed except in
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ComplianceRegulatoryInformation/
Guidances/default.htm or http:// posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
www.regulations.gov. • If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
Dated: December 8, 2015. do not wish to be made available to the comments to public dockets, see 80 FR
Leslie Kux, public, submit the comment as a 56469, September 18, 2015, or access
Associate Commissioner for Policy. written/paper submission and in the the information at: http://www.fda.gov/
[FR Doc. 2015–31406 Filed 12–14–15; 8:45 am] manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). default.htm.
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Document Created: 2018-03-02 09:15:50
Document Modified: 2018-03-02 09:15:50
| 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 March 14, 2016. | |
| 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 | 80 FR 77636 |
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