[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6574-6575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4482]


Regulation of Mosquito-Related Products; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry (GFI) #236 entitled 
``Regulation of Mosquito-Related Products.'' This draft guidance 
provides information regarding regulatory oversight of mosquito-related 
products, defined as those articles for use in or on mosquitoes. We are 
clarifying circumstances under which such products are regulated by FDA 
as new animal drugs under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) and other circumstances under which such products are 
regulated by the Environmental Protection Agency (EPA) as pesticides 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 21, 2017.

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-4482 for ``Regulation of Mosquito-Related Products.'' 
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 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 https://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

[[Page 6575]]

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 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
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: Laura R. Epstein, Center for 
Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-796-8558, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(GFI) #236 entitled ``Regulation of Mosquito-Related Products.'' This 
draft guidance provides information for industry and other stakeholders 
regarding regulatory oversight of mosquito-related products, defined as 
those articles for use in or on mosquitoes. Given the public health 
implications of mosquito control, FDA is providing this draft guidance 
to clarify the regulatory oversight of mosquito-related products, 
including but not limited to those produced through biotechnology. This 
guidance is important in light of the public health urgency of 
countering the spread of mosquito-borne disease, such as that caused by 
the Zika virus. Vector control is a critical element of the effort to 
combat the spread of mosquito-borne disease. Novel mosquito control 
technologies have gained greater attention as an element of this 
effort; however, there has been some confusion with respect to FDA's 
and EPA's respective jurisdiction over such mosquito-related products. 
We are clarifying circumstances under which such products are regulated 
by FDA as new animal drugs under the FD&C Act and other circumstances 
under which such products are regulated by the EPA as pesticides under 
FIFRA. FDA is clarifying that the phrase ``articles (other than food) 
intended to affect the structure or any function of the body of man or 
other animals'' in the FD&C Act's drug definition (21 U.S.C. 
321(g)(1)(C)) does not include articles intended to function as 
pesticides by preventing, destroying, repelling, or mitigating 
mosquitoes for population control purposes. FDA believes that this 
interpretation is consistent with congressional intent and provides a 
rational approach for dividing responsibilities between FDA and EPA in 
regulating mosquito-related products.

II. Significance of Guidance

    This level 1 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 
Regulation of Mosquito-Related Products. 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 with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00838 Filed 1-18-17; 8:45 am]
 BILLING CODE 4164-01-P