46500 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 

P140003) was initially submitted on 

March 20, 2014. 

3. The date the application was 

approved: March 23, 2015. FDA has 

verified the applicant’s claim that PMA 

P140003 was approved on March 23, 

2015. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,796 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21436 Filed 10–4–17; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


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Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 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 selfaddressed 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, 

Laura.Epstein@fda.hhs.gov. 

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 MosquitoRelated 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 mosquitorelated 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 


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