82 FR 6574 - Regulation of Mosquito-Related Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6574-6575 | |
| FR Document | 2017-00838 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Notices] [Pages 6574-6575] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00838] ----------------------------------------------------------------------- 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AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-4482] Regulation of Mosquito-Related Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #236 entitled ``Regulation of Mosquito-Related Products.'' This draft guidance provides information regarding regulatory oversight of mosquito-related products, defined as those articles for use in or on mosquitoes.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.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
![6574 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices
Review on the FDA–EPA’s Technical Dated: January 11, 2017. confidential information that you or a
Information on the Development of Fish Jeremy Sharp, third party may not wish to be posted,
Consumption Advice, available at http:// Deputy Commissioner for Policy, Planning, such as medical information, your or
www.fda.gov/fishadvice and http:// Legislation, and Analysis. anyone else’s Social Security number, or
www.fda.gov/ScienceResearch/Special
[FR Doc. 2017–01073 Filed 1–18–17; 8:45 am] confidential business information, such
Topics/PeerReviewofScientific
InformationandAssessments/ BILLING CODE 4164–01–P as a manufacturing process. Please note
ucm079120.htm. that if you include your name, contact
5. Institute of Medicine, Committee on information, or other information that
Nutrient Relationships in Seafood: DEPARTMENT OF HEALTH AND identifies you in the body of your
‘‘Selections to Balance Benefits and HUMAN SERVICES comments, that information will be
Risks,’’ (2007). Seafood Choices, posted on https://www.regulations.gov.
Balancing Benefits and Risks. The Food and Drug Administration • If you want to submit a comment
National Academies Press, Washington, with confidential information that you
DC. [Docket No. FDA–2016–D–4482]
do not wish to be made available to the
6. ‘‘Mercury Levels in Commercial Fish and public, submit the comment as a
Shellfish 1990–2010,’’ available at http:// Regulation of Mosquito-Related
Products; Draft Guidance for Industry; written/paper submission and in the
www.fda.gov/Food/FoodborneIllness
Availability manner detailed (see ‘‘Written/Paper
Contaminants/Metals/ucm115644.htm.
7. Karimi, R., Fitzgerald, T.P., and Fisher,
Submissions’’ and ‘‘Instructions’’).
N.S. (2012). ‘‘A Quantitative Synthesis of
AGENCY: Food and Drug Administration,
HHS. Written/Paper Submissions
Mercury in Commercial Seafood and
Implications for Exposure in the United ACTION: Notice of availability. Submit written/paper submissions as
States.’’ Environ Health Perspect 120, follows:
1512–1519, available at http:// SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
ehp.niehs.nih.gov/1205122/. Administration (FDA or Agency) is written/paper submissions): Division of
8. U.S. Environmental Protection Agency announcing the availability of a draft Dockets Management (HFA–305), Food
(U.S. EPA) 2003. Mercury in Marine Life guidance for industry (GFI) #236 and Drug Administration, 5630 Fishers
Database. Office of Wetlands, Oceans entitled ‘‘Regulation of Mosquito- Lane, Rm. 1061, Rockville, MD 20852.
and Watersheds, available at https:// Related Products.’’ This draft guidance • For written/paper comments
cfpub.epa.gov/si/si_public_record_ provides information regarding submitted to the Division of Dockets
Report.cfm?dirEntryId=58213. Management, FDA will post your
regulatory oversight of mosquito-related
9. U.S. Environmental Protection Agency. comment, as well as any attachments,
(U.S. EPA) (2016). National Coastal products, defined as those articles for
use in or on mosquitoes. We are except for information submitted,
Assessment (NCA): Northeast 2000–2006
Summary Data, available at https:// clarifying circumstances under which marked and identified, as confidential,
archive.epa.gov/emap/archive-emap/ such products are regulated by FDA as if submitted as detailed in
web/html/index-124.html. new animal drugs under the Federal ‘‘Instructions.’’
10. U.S. Environmental Protection Agency Food, Drug, and Cosmetic Act (the Instructions: All submissions received
(U.S. EPA). (2016). National Coastal FD&C Act) and other circumstances must include the Docket No. FDA–
Condition Assessment (NCCA) Office of under which such products are 2016–D–4482 for ‘‘Regulation of
Water & Office of Research Development, regulated by the Environmental Mosquito-Related Products.’’ Received
EPA 841–R–15–006, Washington, DC. comments will be placed in the docket
Protection Agency (EPA) as pesticides
2010 Results, available at https:// and, except for those submitted as
www.epa.gov/national-aquatic-resource- under the Federal Insecticide,
Fungicide, and Rodenticide Act ‘‘Confidential Submissions,’’ publicly
surveys/national-coastal-condition-
(FIFRA). viewable at https://www.regulations.gov
assessment-2010-results.
11. Health Canada, (2007) Human Health or at the Division of Dockets
DATES: Although you can comment on Management between 9 a.m. and 4 p.m.,
Risk Assessment of Mercury in Fish and any guidance at any time (see 21 CFR
Health Benefits of Fish Consumption, Monday through Friday.
10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To
Bureau of Chemical Safety Food
Directorate Health Products and Food considers your comment on this draft submit a comment with confidential
Branch, Ottawa, Ontario, Canada. guidance before it begins work on the information that you do not wish to be
12. Cladis, D.P., Kleiner, A.C., and Santerre, final version of the guidance, submit made publicly available, submit your
C.R. (2014). ‘‘Mercury Content in either electronic or written comments comments only as a written/paper
Commercially Available Finfish in the on the draft guidance by February 21, submission. You should submit two
United States.’’ J Food Prot 77, 1361– 2017. copies total. One copy will include the
1366, available at http://
ADDRESSES: You may submit comments information you claim to be confidential
www.ncbi.nlm.nih.gov/pubmed/
25198598. as follows: with a heading or cover note that states
13. FDA–EPA Fish Advice: Technical ‘‘THIS DOCUMENT CONTAINS
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Information, available at http://
www.fda.gov/fishadvice. Submit electronic comments in the Agency will review this copy, including
14. Lando, A.M., S.B. Fein, and C.J. following way: the claimed confidential information, in
Choinière, ‘‘Awareness of • Federal eRulemaking Portal: its consideration of comments. The
Methylmercury in Fish and Fish https://www.regulations.gov. Follow the second copy, which will have the
Consumption Among Pregnant and instructions for submitting comments. claimed confidential information
mstockstill on DSK3G9T082PROD with NOTICES
Postpartum and Women of Childbearing Comments submitted electronically, redacted/blacked out, will be available
Age in the United States,’’
including attachments, to https:// for public viewing and posted on
Environmental Research, vol. 116, pp.
85–92, 2012. www.regulations.gov will be posted to https://www.regulations.gov. Submit
15. U.S. Environmental Protection Agency’s the docket unchanged. Because your both copies to the Division of Dockets
Integrated Risk Information System comment will be made public, you are Management. If you do not wish your
(IRIS), available at http://www.epa.gov/ solely responsible for ensuring that your name and contact information to be
iris/subst/0073.htm. comment does not include any made publicly available, you can
VerDate Sep<11>2014 21:20 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/82_FR_6586/page/1.svg)
![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6575
provide this information on the cover attention as an element of this effort; DEPARTMENT OF HEALTH AND
sheet and not in the body of your however, there has been some confusion HUMAN SERVICES
comments and you must identify this with respect to FDA’s and EPA’s
information as ‘‘confidential.’’ Any respective jurisdiction over such Food and Drug Administration
information marked as ‘‘confidential’’ mosquito-related products. We are [Docket No. FDA–2016–D–2285]
will not be disclosed except in clarifying circumstances under which
accordance with 21 CFR 10.20 and other such products are regulated by FDA as Medical Product Communications That
applicable disclosure law. For more new animal drugs under the FD&C Act Are Consistent With the Food and
information about FDA’s posting of and other circumstances under which Drug Administration-Required
comments to public dockets, see 80 FR such products are regulated by the EPA Labeling—Questions and Answers;
56469, September 18, 2015, or access as pesticides under FIFRA. FDA is Draft Guidance for Industry;
the information at: http://www.fda.gov/ clarifying that the phrase ‘‘articles (other Availability
regulatoryinformation/dockets/
than food) intended to affect the AGENCY: Food and Drug Administration,
default.htm.
structure or any function of the body of HHS.
Docket: For access to the docket to
read background documents or the man or other animals’’ in the FD&C ACTION: Notice of availability.
electronic and written/paper comments Act’s drug definition (21 U.S.C.
321(g)(1)(C)) does not include articles SUMMARY: The Food and Drug
received, go to https:// Administration (FDA or Agency) is
www.regulations.gov and insert the intended to function as pesticides by
preventing, destroying, repelling, or announcing the availability of a draft
docket number, found in brackets in the guidance for industry entitled ‘‘Medical
heading of this document, into the mitigating mosquitoes for population
Product Communications That Are
‘‘Search’’ box and follow the prompts control purposes. FDA believes that this Consistent With the FDA-Required
and/or go to the Division of Dockets interpretation is consistent with Labeling—Questions and Answers.’’
Management, 5630 Fishers Lane, Rm. congressional intent and provides a This draft guidance provides
1061, Rockville, MD 20852. rational approach for dividing information for manufacturers, packers,
Submit written requests for single responsibilities between FDA and EPA and distributors and their
copies of the guidance to the Policy and in regulating mosquito-related products. representatives (collectively ‘‘firms’’) of
Regulations Staff (HFV–6), Center for drugs and medical devices for humans,
Veterinary Medicine, Food and Drug II. Significance of Guidance
including those that are licensed as
Administration, 7519 Standish Pl., This level 1 draft guidance is being biological products, and animal drugs
Rockville, MD 20855. Send one self- issued consistent with FDA’s good (collectively ‘‘medical products’’), about
addressed adhesive label to assist that guidance practices regulation (21 CFR how FDA evaluates their medical
office in processing your requests. See product communications, including
10.115). The draft guidance, when
the SUPPLEMENTARY INFORMATION section their promotional materials, that present
finalized, will represent the current
for electronic access to the draft information that is not contained in the
thinking of FDA on Regulation of
guidance document. FDA-required labeling for the product
Mosquito-Related Products. It does not
FOR FURTHER INFORMATION CONTACT: but that may be consistent with the
establish any rights for any person and
Laura R. Epstein, Center for Veterinary FDA-required labeling for the product.
is not binding on FDA or the public.
Medicine (HFV–1), Food and Drug The Agency is issuing this draft
You can use an alternative approach if
Administration, 7519 Standish Pl., guidance to explain FDA’s current
Rockville, MD 20855, 301–796–8558, it satisfies the requirements of the
thinking on commonly asked questions
Laura.Epstein@fda.hhs.gov. applicable statutes and regulations.
regarding such communications in order
SUPPLEMENTARY INFORMATION: III. Electronic Access to provide clarity for firms.
DATES: Although you can comment on
I. Background Persons with access to the Internet any guidance at any time (see 21 CFR
FDA is announcing the availability of may obtain the draft guidance at either 10.115(g)(5)), to ensure that the Agency
a draft guidance for industry (GFI) #236 http://www.fda.gov/AnimalVeterinary/ considers your comment on this draft
entitled ‘‘Regulation of Mosquito- GuidanceComplianceEnforcement/ guidance before it begins work on the
Related Products.’’ This draft guidance GuidanceforIndustry/default.htm or final version of the guidance, submit
provides information for industry and https://www.regulations.gov. either electronic or written comments
other stakeholders regarding regulatory Dated: January 11, 2017. on the draft guidance by April 19, 2017.
oversight of mosquito-related products, ADDRESSES: You may submit comments
defined as those articles for use in or on Leslie Kux,
as follows:
mosquitoes. Given the public health Associate Commissioner for Policy.
implications of mosquito control, FDA [FR Doc. 2017–00838 Filed 1–18–17; 8:45 am] Electronic Submissions
is providing this draft guidance to BILLING CODE 4164–01–P Submit electronic comments in the
clarify the regulatory oversight of following way:
mosquito-related products, including • Federal eRulemaking Portal:
but not limited to those produced https://www.regulations.gov. Follow the
through biotechnology. This guidance is instructions for submitting comments.
important in light of the public health Comments submitted electronically,
mstockstill on DSK3G9T082PROD with NOTICES
urgency of countering the spread of including attachments, to https://
mosquito-borne disease, such as that www.regulations.gov will be posted to
caused by the Zika virus. Vector control the docket unchanged. Because your
is a critical element of the effort to comment will be made public, you are
combat the spread of mosquito-borne solely responsible for ensuring that your
disease. Novel mosquito control comment does not include any
technologies have gained greater confidential information that you or a
VerDate Sep<11>2014 21:20 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/82_FR_6586/page/2.svg)
Document Created: 2018-02-01 15:15:52
Document Modified: 2018-02-01 15:15:52
| 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 | 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. | |
| 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] | |
| FR Citation | 82 FR 6574 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR