Clarification of the Food and Drug Administration and Environmental Protection Agency Jurisdiction Over Mosquito-Related Products; Guidance for Industry; Availability, 46500-46501 [2017-21494]
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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
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However, the USPTO applies several
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of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,796 days of patent
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III. Petitions
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Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
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regarding whether the applicant for
extension acted with due diligence
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meet its burden, the petition must
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must be timely (see DATES), must be
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Petitions should be in the format
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Submit petitions electronically to
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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]
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19:52 Oct 04, 2017
Jkt 244001
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.
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:
SUMMARY:
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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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
E:\FR\FM\05OCN1.SGM
05OCN1
Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
ethrower on DSK3G9T082PROD with NOTICES
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
VerDate Sep<11>2014
19:52 Oct 04, 2017
Jkt 244001
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
PO 00000
Frm 00026
Fmt 4703
Sfmt 9990
46501
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
E:\FR\FM\05OCN1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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
[[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,
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 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