81 FR 11810 - Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 44 (March 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 44 (March 7, 2016)
| Page Range | 11810-11811 | |
| FR Document | 2016-04946 |
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)] [Notices] [Pages 11810-11811] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04946] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1849] Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Guidance for Industry and Food and Drug Administration Staff; 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 the guidance entitled ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' This guidance is intended to provide recommendations regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome 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-2014-D-1849 for ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' 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. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Shlomit Halachmi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G439, Silver Spring, MD 20993-0002, 301- 796-6338. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and FDA staff [[Page 11811]] entitled ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' This guidance is intended to provide recommendations regarding clinical trial design for medical devices intended either (1) to provide improvement in the appearance of nails affected by onychomycosis, or (2) to treat onychomycosis (fungal nail infection). In the Federal Register on January 27, 2015 (80 FR 4281), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by April 27, 2015. II. Significance of 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 medical devices and clinical trial design for the treatment or improvement in the appearance of fungally-infected nails. 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. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400009 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 are approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814, subparts B and E are approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H are approved under OMB control number 0910-0332; the collections of information regarding adverse events have been approved under OMB control number 0910-0471; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. The labeling recommendations of this guidance are not subject to review by the Office of Management and Budget because they do not constitute a ``collection of information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the recommended labeling is a ``public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public'' (see 5 CFR 1320.3(c)(2)). Dated: March 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04946 Filed 3-4-16; 8:45 am] BILLING CODE 4164-01-P
![11810 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
II. Paperwork Reduction Act of 1995 • Federal eRulemaking Portal: http:// Agency will review this copy, including
This guidance refers to previously www.regulations.gov. Follow the the claimed confidential information, in
approved collections of information instructions for submitting comments. its consideration of comments. The
found in FDA regulations. These Comments submitted electronically, second copy, which will have the
collections of information are subject to including attachments, to http:// claimed confidential information
review by the Office of Management and www.regulations.gov will be posted to redacted/blacked out, will be available
Budget (OMB) under the Paperwork the docket unchanged. Because your for public viewing and posted on
Reduction Act of 1995 (44 U.S.C. 3501– comment will be made public, you are http://www.regulations.gov. Submit
3520). The collections of information in solely responsible for ensuring that your both copies to the Division of Dockets
part 1271 have been approved under comment does not include any Management. If you do not wish your
OMB control number 0910–0543. confidential information that you or a name and contact information to be
third party may not wish to be posted, made publicly available, you can
III. Electronic Access such as medical information, your or provide this information on the cover
Persons with access to the Internet anyone else’s Social Security number, or sheet and not in the body of your
may obtain the guidance at either http:// confidential business information, such comments and you must identify this
www.fda.gov/BiologicsBloodVaccines/ as a manufacturing process. Please note information as ‘‘confidential.’’ Any
GuidanceComplianceRegulatory that if you include your name, contact information marked as ‘‘confidential’’
Information/Guidances/default.htm or information, or other information that will not be disclosed except in
http://www.regulations.gov. identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
Dated: March 1, 2016. posted on http://www.regulations.gov. information about FDA’s posting of
Leslie Kux, • If you want to submit a comment comments to public dockets, see 80 FR
Associate Commissioner for Policy. with confidential information that you 56469, September 18, 2015, or access
[FR Doc. 2016–04893 Filed 3–4–16; 8:45 am] do not wish to be made available to the the information at: http://www.fda.gov/
BILLING CODE 4164–01–P public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). read background documents or the
HUMAN SERVICES electronic and written/paper comments
Written/Paper Submissions
Food and Drug Administration received, go to http://
Submit written/paper submissions as
www.regulations.gov and insert the
[Docket No. FDA–2014–D–1849] follows:
docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
heading of this document, into the
Medical Devices and Clinical Trial written/paper submissions): Division of
‘‘Search’’ box and follow the prompts
Design for the Treatment or Dockets Management (HFA–305), Food
and/or go to the Division of Dockets
Improvement in the Appearance of and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
Fungally-Infected Nails; Guidance for Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 1061, Rockville, MD 20852.
Industry and Food and Drug An electronic copy of the guidance
Administration Staff; Availability submitted to the Division of Dockets
Management, FDA will post your document is available for download
AGENCY: Food and Drug Administration, comment, as well as any attachments, from the Internet. See the
HHS. SUPPLEMENTARY INFORMATION section for
except for information submitted,
ACTION: Notice of availability. marked and identified, as confidential, information on electronic access to the
if submitted as detailed in guidance. Submit written requests for a
SUMMARY: The Food and Drug ‘‘Instructions.’’ single hard copy of the guidance
Administration (FDA or Agency) is Instructions: All submissions received document entitled ‘‘Medical Devices
announcing the availability of the must include the Docket No. FDA– and Clinical Trial Design for the
guidance entitled ‘‘Medical Devices and 2014–D–1849 for ‘‘Medical Devices and Treatment or Improvement in the
Clinical Trial Design for the Treatment Clinical Trial Design for the Treatment Appearance of Fungally-Infected Nails’’
or Improvement in the Appearance of or Improvement in the Appearance of to the Office of the Center Director,
Fungally-Infected Nails.’’ This guidance Fungally-Infected Nails.’’ Received Guidance and Policy Development,
is intended to provide recommendations comments will be placed in the docket Center for Devices and Radiological
regarding clinical trial design for and, except for those submitted as Health, Food and Drug Administration,
medical devices intended either to ‘‘Confidential Submissions,’’ publicly 10903 New Hampshire Ave., Bldg. 66,
provide improvement in the appearance viewable at http://www.regulations.gov Rm. 5431, Silver Spring, MD 20993–
of nails affected by onychomycosis or to or at the Division of Dockets 0002. Send one self-addressed adhesive
treat onychomycosis (fungal nail Management between 9 a.m. and 4 p.m., label to assist that office in processing
infection). Monday through Friday. your request.
DATES: Submit either electronic or • Confidential Submissions—To FOR FURTHER INFORMATION CONTACT:
written comments on this guidance at submit a comment with confidential Shlomit Halachmi, Center for Devices
any time. General comments on Agency information that you do not wish to be and Radiological Health, Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
guidance documents are welcome at any made publicly available, submit your Administration, 10903 New Hampshire
time. comments only as a written/paper Ave., Bldg. 66, Rm. G439, Silver Spring,
ADDRESSES: You may submit comments submission. You should submit two MD 20993–0002, 301–796–6338.
as follows: copies total. One copy will include the SUPPLEMENTARY INFORMATION:
information you claim to be confidential
Electronic Submissions with a heading or cover note that states I. Background
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS FDA is announcing the availability of
following way: CONFIDENTIAL INFORMATION.’’ The a guidance for industry and FDA staff
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![Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 11811
entitled ‘‘Medical Devices and Clinical 0910–0078; the collections of ADDRESSES: You may submit comments
Trial Design for the Treatment or information in 21 CFR part 814, as follows:
Improvement in the Appearance of subparts B and E are approved under
Electronic Submissions
Fungally-Infected Nails.’’ This guidance OMB control number 0910–0231; the
is intended to provide recommendations collections of information in 21 CFR Submit electronic comments in the
regarding clinical trial design for part 814, subpart H are approved under following way:
medical devices intended either (1) to OMB control number 0910–0332; the • Federal eRulemaking Portal: http://
provide improvement in the appearance collections of information regarding www.regulations.gov. Follow the
of nails affected by onychomycosis, or adverse events have been approved instructions for submitting comments.
(2) to treat onychomycosis (fungal nail under OMB control number 0910–0471; Comments submitted electronically,
infection). and the collections of information in 21 including attachments, to http://
In the Federal Register on January 27, CFR part 801 have been approved under www.regulations.gov will be posted to
2015 (80 FR 4281), FDA announced the OMB control number 0910–0485. the docket unchanged. Because your
availability of the draft guidance The labeling recommendations of this comment will be made public, you are
document. Interested persons were guidance are not subject to review by solely responsible for ensuring that your
invited to comment by April 27, 2015. the Office of Management and Budget comment does not include any
because they do not constitute a confidential information that you or a
II. Significance of Guidance
‘‘collection of information’’ under the third party may not wish to be posted,
This guidance is being issued Paperwork Reduction Act of 1995 (44 such as medical information, your or
consistent with FDA’s good guidance U.S.C. 3501–3520). Rather, the anyone else’s Social Security number, or
practices regulation (21 CFR 10.115). recommended labeling is a ‘‘public confidential business information, such
The guidance represents the current disclosure of information originally as a manufacturing process. Please note
thinking of FDA on medical devices and supplied by the Federal Government to that if you include your name, contact
clinical trial design for the treatment or the recipient for the purpose of information, or other information that
improvement in the appearance of disclosure to the public’’ (see 5 CFR identifies you in the body of your
fungally-infected nails. It does not 1320.3(c)(2)). comments, that information will be
establish any rights for any person and posted on http://www.regulations.gov.
is not binding on FDA or the public. Dated: March 1, 2016. • If you want to submit a comment
You can use an alternative approach if Leslie Kux, with confidential information that you
it satisfies the requirements of the Associate Commissioner for Policy. do not wish to be made available to the
applicable statutes and regulations. [FR Doc. 2016–04946 Filed 3–4–16; 8:45 am] public, submit the comment as a
III. Electronic Access BILLING CODE 4164–01–P written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Persons interested in obtaining a copy Submissions’’ and ‘‘Instructions’’).
of the guidance may do so by DEPARTMENT OF HEALTH AND
downloading an electronic copy from HUMAN SERVICES Written/Paper Submissions
the Internet. A search capability for all Submit written/paper submissions as
Center for Devices and Radiological Food and Drug Administration follows:
Health guidance documents is available [Docket No. FDA–2015–D–1213] • Mail/Hand delivery/Courier (for
at http://www.fda.gov/MedicalDevices/ written/paper submissions): Division of
DeviceRegulationandGuidance/ Environmental Assessment: Questions Dockets Management (HFA–305), Food
GuidanceDocuments/default.htm. and Answers Regarding Drugs With and Drug Administration, 5630 Fishers
Guidance documents are also available Estrogenic, Androgenic, or Thyroid Lane, Rm. 1061, Rockville, MD 20852.
at http://www.regulations.gov. Persons Activity; Guidance for Industry; • For written/paper comments
unable to download an electronic copy Availability submitted to the Division of Dockets
of ‘‘Medical Devices and Clinical Trial Management, FDA will post your
Design for the Treatment or AGENCY: Food and Drug Administration, comment, as well as any attachments,
Improvement in the Appearance of HHS. except for information submitted,
Fungally-Infected Nails’’ may send an ACTION: Notice of availability. marked and identified, as confidential,
email request to CDRH-Guidance@ if submitted as detailed in
fda.hhs.gov to receive an electronic SUMMARY: The Food and Drug ‘‘Instructions.’’
copy of the document. Please use the Administration (FDA or Agency) is Instructions: All submissions received
document number 1400009 to identify announcing the availability of a must include the Docket No. FDA–
the guidance you are requesting. guidance for industry entitled 2015–D–1213 for Environmental
‘‘Environmental Assessment: Questions Assessment: Questions and Answers
IV. Paperwork Reduction Act of 1995 and Answers Regarding Drugs With Regarding Drugs with Estrogenic,
This guidance refers to previously Estrogenic, Androgenic, or Thyroid Androgenic, or Thyroid Activity.
approved collections of information Activity.’’ It is intended to help Received comments will be placed in
found in FDA regulations. These sponsors of such drugs determine the docket and, except for those
collections of information are subject to whether they should submit submitted as ‘‘Confidential
review by the Office of Management and environmental assessments (EA) for Submissions,’’ publicly viewable at
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Budget (OMB) under the Paperwork drug applications and certain http://www.regulations.gov or at the
Reduction Act of 1995 (44 U.S.C. 3501– supplements, and to clarify what Division of Dockets Management
3520). The collections of information in information such sponsors should between 9 a.m. and 4 p.m., Monday
21 CFR part 807, subpart E have been include if they submit a claim of through Friday.
approved under OMB control number categorical exclusion instead of an EA. • Confidential Submissions—To
0910–0120; the collections of DATES: Submit either electronic or submit a comment with confidential
information in 21 CFR part 812 are written comments on Agency guidances information that you do not wish to be
approved under OMB control number at any time. made publicly available, submit your
VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\07MRN1.SGM 07MRN1](https://thefederalregister.org/doc/81_FR_11854/page/2.svg)
Document Created: 2018-02-02 15:08:08
Document Modified: 2018-02-02 15:08:08
| 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 this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Shlomit Halachmi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G439, Silver Spring, MD 20993-0002, 301- 796-6338. | |
| FR Citation | 81 FR 11810 |
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