[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46500-46501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21494]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Clarification of the Food and Drug Administration and 
Environmental Protection Agency Jurisdiction Over Mosquito-Related 
Products; 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 guidance for industry #236 entitled 
``Clarification of FDA and EPA Jurisdiction Over Mosquito-Related 
Products.'' This 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 the Food and Drug Administration (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: The announcement of the guidance is published in the Federal 
Register on October 5, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time 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-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 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 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

[[Page 46501]]

the information at: https://www.gpo.gov/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 guidance document.

FOR FURTHER INFORMATION CONTACT: Laura R. Epstein, Center for 
Veterinary Medicine (HFV-1), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-796-8558, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of January 19, 2017 (82 FR 6574), FDA 
published the notice of availability for a draft guidance entitled 
``Regulation of Mosquito-Related Products'' giving interested persons 
until February 21, 2017, to comment on the draft guidance. FDA has 
finalized that draft guidance and is issuing final guidance entitled 
``Clarification of FDA and EPA Jurisdiction over Mosquito-Related 
Products.'' This 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 guidance to clarify the regulatory jurisdiction 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 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.
    FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. Some comments 
on the draft guidance expressed confusion about how the intended use of 
a product can determine whether a product is a drug or a pesticide. The 
definition of ``drug'' in the FD&C Act depends upon the ``intended 
use'' of a product. A product is a drug if it is intended to do certain 
things (i.e., if it is ``intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease . . .'' and ``to affect 
the structure or any function of the body . . .'' and for use as a 
component of such a product. (21 U.S.C. 321(g)(1)). Even when 
considering products subject only to the FD&C Act, the same product may 
be classified differently depending on the intended use. For example, 
an article that is intended to treat disease in an animal is an animal 
drug, while the same article if intended to control mold growth in 
animal feed could be a food additive (i.e., a substance ``the intended 
use of which results . . . in its becoming a component or otherwise 
affecting the characteristics of any food . . . if such substance is 
not generally recognized among experts qualified by scientific training 
and experience to evaluate its safety as having been adequately been 
shown . . . to be safe. . . .''). Similarly, whether a product is a 
``pesticide'' under FIFRA also depends upon intended use (``pesticide'' 
means, among other things, any substance or mixture of substances 
intended for preventing, destroying, repelling, or mitigating any 
pest). As a commenter pointed out, this means that the same product can 
be a drug when intended for one use (i.e., diagnosing, curing, 
mitigating, treating, or preventing disease) and a pesticide when 
intended for another use (i.e., preventing, destroying, repelling, or 
mitigating a pest). We have updated the guidance document in response 
to these comments (see section III.C. of the guidance document). We 
have also revised the title of the guidance document to better reflect 
the scope of the document.

II. Significance of Guidance

    This level 1 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 ``Clarification of FDA and EPA 
Jurisdiction Over 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. This guidance clarifies regulatory 
jurisdiction and is not a significant regulatory action subject to 
Executive Order 12866. Because FDA is clarifying that the definition of 
``drug'' in the FD&C Act does not include articles intended to function 
as pesticides by preventing, destroying, repelling, or mitigating 
mosquitoes for population control purposes, it is a deregulatory action 
on the part of FDA in that it clarifies that the manufacturers of such 
articles will no longer be subject to FDA's regulatory jurisdiction.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: October 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21494 Filed 10-4-17; 8:45 am]
 BILLING CODE 4164-01-P