82 FR 34680 - Consumer Antiseptic Wash Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 142 (July 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 142 (July 26, 2017)
| Page Range | 34680-34681 | |
| FR Document | 2017-15653 |
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)] [Notices] [Pages 34680-34681] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15653] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-3906] Consumer Antiseptic Wash Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Consumer Antiseptic Wash Final Rule Questions and Answers.'' We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to assist small businesses in better understanding and complying with the consumer antiseptic wash final rule, which established that certain active ingredients, including triclosan, used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE). This guidance explains the scope of the final rule, how and when manufacturers must comply with the final rule, and which consumer antiseptic wash active ingredients were deferred from the final rule. 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: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-3906 for ``Consumer Antiseptic Wash Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 [[Page 34681]] https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 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: Pranvera Ikonomi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240- 402-0272. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Consumer Antiseptic Wash Final Rule Questions and Answers.'' We are issuing this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-28) \1\ to assist small businesses in better understanding and complying with the consumer antiseptic wash final rule (September 6, 2016, 81 FR 61106), which established that certain active ingredients used in OTC consumer antiseptic wash products are not GRASE. This guidance explains the scope of the final rule and identifies which active ingredients were found not to be GRASE for use in consumer antiseptic wash products. This guidance explains when and how manufacturers must comply with the final rule. This guidance also explains the significance of triclosan and triclocarban under this final rule. In addition, this guidance identifies which consumer antiseptic wash active ingredients were deferred from the final rule and explains what the effectiveness and safety criteria are for these deferred consumer antiseptic wash active ingredients. --------------------------------------------------------------------------- \1\ 5 U.S.C. 601 (note). --------------------------------------------------------------------------- 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 how small businesses can better understand and comply with the consumer antiseptic wash final rule. 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: July 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15653 Filed 7-25-17; 8:45 am] BILLING CODE 4164-01-P
![34680 Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices
Administration, 10001 New Hampshire II. Electronic Access the docket unchanged. Because your
Ave., Hillandale Building, 4th Floor, Persons with access to the Internet comment will be made public, you are
Silver Spring, MD 20993–0002, 240– may obtain the guidance at either solely responsible for ensuring that your
402–5118. https://www.fda.gov/Drugs/Guidance comment does not include any
SUPPLEMENTARY INFORMATION: ComplianceRegulatoryInformation/ confidential information that you or a
Guidances/default.htm or https:// third party may not wish to be posted,
I. Background such as medical information, your or
www.regulations.gov.
GDUFA (Pub. L. 112–144, Title III) anyone else’s Social Security number, or
Dated: July 20, 2017. confidential business information, such
was signed into law by the President on
Anna K. Abram, as a manufacturing process. Please note
July 9, 2012. GDUFA is designed to
speed the delivery of safe and effective Deputy Commissioner for Policy, Planning, that if you include your name, contact
Legislation, and Analysis. information, or other information that
generic drugs to the public and to
improve the review process for ANDAs. [FR Doc. 2017–15654 Filed 7–25–17; 8:45 am] identifies you in the body of your
GDUFA enables FDA to assess user fees BILLING CODE 4164–01–P comments, that information will be
to support critical and measurable posted on https://www.regulations.gov.
enhancements to FDA’s generic drugs • If you want to submit a comment
program. DEPARTMENT OF HEALTH AND with confidential information that you
On August 27, 2012, FDA announced HUMAN SERVICES do not wish to be made available to the
the availability of a draft guidance for public, submit the comment as a
Food and Drug Administration written/paper submission and in the
industry entitled ‘‘Generic Drug User
Fee Amendments of 2012: Questions [Docket No. FDA–2017–D–3906] manner detailed (see ‘‘Written/Paper
and Answers’’ (77 FR 51814). On Submissions’’ and ‘‘Instructions’’).
September 10, 2013, FDA announced Consumer Antiseptic Wash Final Rule Written/Paper Submissions
the availability of a revised version of Questions and Answers; Guidance for
Industry; Small Entity Compliance Submit written/paper submissions as
this guidance (78 FR 55261). The follows:
comment period on the revised draft Guide; Availability
• Mail/Hand delivery/Courier (for
guidance ended on December 11, 2013 AGENCY: Food and Drug Administration, written/paper submissions): Dockets
(78 FR 70953). FDA received several HHS. Management Staff (HFA–305), Food and
comments on the draft guidance, and ACTION: Notice of availability. Drug Administration, 5630 Fishers
these comments as well as FDA’s Lane, Rm. 1061, Rockville, MD 20852.
experience implementing GDUFA were SUMMARY: The Food and Drug • For written/paper comments
considered as the guidance was Administration (FDA, the Agency, or submitted to the Dockets Management
finalized. we) is announcing the availability of a Staff, FDA will post your comment, as
This guidance is intended to provide guidance for industry entitled well as any attachments, except for
answers to common questions from ‘‘Consumer Antiseptic Wash Final Rule information submitted, marked, and
generic drug industry participants and Questions and Answers.’’ We are identified as confidential, if submitted
other interested parties involved in the issuing this guidance in accordance as detailed in ‘‘Instructions.’’
development and/or testing of generic with the Small Business Regulatory Instructions: All submissions received
drug products regarding FDA’s Enforcement Fairness Act to assist small must include the Docket No. FDA–
implementation of GDUFA. This businesses in better understanding and 2017–D–3906 for ‘‘Consumer Antiseptic
guidance includes three categories of complying with the consumer antiseptic Wash Final Rule Questions and
questions and answers: Self- wash final rule, which established that Answers; Guidance for Industry; Small
identification of facilities, sites, and certain active ingredients, including Entity Compliance Guide.’’ Received
organizations; review of generic drug triclosan, used in over-the-counter comments will be placed in the docket
submissions; and inspections and (OTC) consumer antiseptic wash and, except for those submitted as
compliance. The draft versions of this products are not generally recognized as ‘‘Confidential Submissions,’’ publicly
guidance also addressed the subject of safe and effective (GRASE). This viewable at https://www.regulations.gov
fees. The portion of the draft guidance guidance explains the scope of the final or at the Dockets Management Staff
relating to fees was updated and rule, how and when manufacturers must between 9 a.m. and 4 p.m., Monday
finalized in November 2016 (81 FR comply with the final rule, and which through Friday.
81774, November 18, 2016). consumer antiseptic wash active • Confidential Submissions—To
This guidance is being issued ingredients were deferred from the final submit a comment with confidential
consistent with FDA’s good guidance rule. information that you do not wish to be
practices regulation (21 CFR 10.115). DATES: Submit either electronic or made publicly available, submit your
The guidance represents the current written comments on Agency guidances comments only as a written/paper
thinking of FDA on ‘‘Generic Drug User at any time. submission. You should submit two
Fee Amendments of 2012: Questions ADDRESSES: You may submit comments copies total. One copy will include the
and Answers Related to Self- as follows: information you claim to be confidential
Identification of Facilities, Review of with a heading or cover note that states
Generic Drug Submissions, and Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Inspections and Compliance.’’ It does Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
mstockstill on DSK30JT082PROD with NOTICES
not establish any rights for any person following way: Agency will review this copy, including
and is not binding on FDA or the public. • Federal eRulemaking Portal: the claimed confidential information, in
You can use an alternative approach if https://www.regulations.gov. Follow the its consideration of comments. The
it satisfies the requirements of the instructions for submitting comments. second copy, which will have the
applicable statutes and regulations. This Comments submitted electronically, claimed confidential information
guidance is not subject to Executive including attachments, to https:// redacted/blacked out, will be available
Order 12866. www.regulations.gov will be posted to for public viewing and posted on
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![Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices 34681
https://www.regulations.gov. Submit GRASE. This guidance explains the meeting will be open to the public. This
both copies to the Dockets Management scope of the final rule and identifies meeting will be the inaugural meeting of
Staff. If you do not wish your name and which active ingredients were found not a new advisory committee.
contact information to be made publicly to be GRASE for use in consumer DATES: The meeting will be held on
available, you can provide this antiseptic wash products. This guidance October 11, 2017, from 1 p.m. to 5 p.m.
information on the cover sheet and not explains when and how manufacturers and October 12, 2017, from 8 a.m. to 5
in the body of your comments and you must comply with the final rule. This p.m.
must identify this information as guidance also explains the significance
ADDRESSES: Hilton Washington DC
‘‘confidential.’’ Any information marked of triclosan and triclocarban under this
North/Gaithersburg, Grand Ballroom,
as ‘‘confidential’’ will not be disclosed final rule. In addition, this guidance
620 Perry Pkwy., Gaithersburg, MD
except in accordance with 21 CFR 10.20 identifies which consumer antiseptic
20877. The hotel’s telephone number is
and other applicable disclosure law. For wash active ingredients were deferred
301–977–8900. Answers to commonly
more information about FDA’s posting from the final rule and explains what
asked questions including information
of comments to public dockets, see 80 the effectiveness and safety criteria are
regarding special accommodations due
FR 56469, September 18, 2015, or access for these deferred consumer antiseptic
to a disability, visitor parking, and
the information at: https://www.gpo.gov/ wash active ingredients.
This guidance is being issued transportation may be accessed at:
fdsys/pkg/FR-2015-09-18/pdf/2015- http://www.fda.gov/Advisory
23389.pdf. consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). Committees/AboutAdvisoryCommittees/
Docket: For access to the docket to ucm408555.htm.
read background documents or the The guidance represents the current
electronic and written/paper comments thinking of FDA on how small FOR FURTHER INFORMATION CONTACT:
received, go to https:// businesses can better understand and Letise Williams, Center for Devices and
www.regulations.gov and insert the comply with the consumer antiseptic Radiological Health, Food and Drug
docket number, found in brackets in the wash final rule. It does not establish any Administration, 10903 New Hampshire
heading of this document, into the rights for any person and is not binding Ave., Bldg. 66, Rm. 5441, Silver Spring,
‘‘Search’’ box and follow the prompts on FDA or the public. You can use an MD 20993–0002, 301–796–8398, or FDA
and/or go to the Dockets Management alternative approach if it satisfies the Advisory Committee Information Line,
Staff, 5630 Fishers Lane, Rm. 1061, requirements of the applicable statutes 1–800–741–8138 (301–443–0572 in the
Rockville, MD 20852. and regulations. This guidance is not Washington, DC area). A notice in the
Submit written requests for single subject to Executive Order 12866. Federal Register about last minute
copies of this guidance to the Division modifications that impact a previously
II. Electronic Access
of Drug Information, Center for Drug announced advisory committee meeting
Evaluation and Research, Food and Persons with access to the Internet cannot always be published quickly
Drug Administration, 10001 New may obtain the guidance at either enough to provide timely notice.
Hampshire Ave., Hillandale Building, https://www.fda.gov/Drugs/Guidance Therefore, you should always check the
4th Floor, Silver Spring, MD 20993– ComplianceRegulatoryInformation/ Agency’s Web site at http://
0002. Send one self-addressed adhesive Guidances/default.htm or https:// www.fda.gov/AdvisoryCommittees/
label to assist that office in processing www.regulations.gov. default.htm and scroll down to the
your requests. See the SUPPLEMENTARY Dated: July 20, 2017. appropriate advisory committee meeting
INFORMATION section for electronic Anna K. Abram, link, or call the advisory committee
access to the guidance document. Deputy Commissioner for Policy, Planning, information line to learn about possible
FOR FURTHER INFORMATION CONTACT: Legislation, and Analysis. modifications before coming to the
Pranvera Ikonomi, Center for Drug [FR Doc. 2017–15653 Filed 7–25–17; 8:45 am] meeting.
Evaluation and Research, Food and BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION:
Drug Administration, 10903 New Agenda: On October 11 and 12, 2017,
Hampshire Ave., Bldg. 22, Rm. 5418, the committee will discuss and make
Silver Spring, MD 20993–0002, 240– DEPARTMENT OF HEALTH AND recommendations on the topic of patient
402–0272. HUMAN SERVICES input into medical device clinical trials.
SUPPLEMENTARY INFORMATION: This meeting will provide the
Food and Drug Administration
opportunity to bring patients, patient
I. Background [Docket No. FDA–2017–N–0001] organization, FDA, industry, and other
FDA is announcing the availability of medical and scientific experts together
a guidance for industry entitled Patient Engagement Advisory for a broader discussion on this
‘‘Consumer Antiseptic Wash Final Rule Committee; Notice of Meeting important patient-related issue.
Questions and Answers.’’ We are AGENCY: Food and Drug Administration, This meeting is a key part of FDA’s
issuing this guidance in accordance HHS. goal to help assure the needs and
with section 212 of the Small Business ACTION: Notice. experiences of patients are included as
Regulatory Enforcement Fairness Act part of FDA’s deliberations involving
(Pub. L. 104–121, as amended by Pub. SUMMARY: The Food and Drug the regulation of medical devices and
L. 110–28) 1 to assist small businesses in Administration (FDA) announces a their use by patients. For this meeting,
better understanding and complying forthcoming public advisory committee FDA is seeking input from the PEAC
mstockstill on DSK30JT082PROD with NOTICES
with the consumer antiseptic wash final meeting of the Patient Engagement and the public on topics such as to: (1)
rule (September 6, 2016, 81 FR 61106), Advisory Committee (PEAC). The Better understand challenges for
which established that certain active general function of the committee is to patients in medical device clinical
ingredients used in OTC consumer provide advice and recommendations to trials, (2) better understand how patient
antiseptic wash products are not the Agency on complex issues relating input and engagement is being used to
to medical devices, the regulation of overcome these challenges (potential
15 U.S.C. 601 (note). devices, and their use by patients. The solutions), and (3) receive
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Document Created: 2017-07-26 01:29:56
Document Modified: 2017-07-26 01:29:56
| 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 | Pranvera Ikonomi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240- 402-0272. | |
| FR Citation | 82 FR 34680 |
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