81 FR 87566 - Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds for Minor Species; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 233 (December 5, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 233 (December 5, 2016)
| Page Range | 87566-87568 | |
| FR Document | 2016-29133 |
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)] [Notices] [Pages 87566-87568] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29133] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-1875] Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds for Minor Species; 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 revised Compliance Policy Guide (CPG) 615.115 entitled ``Extralabel Use of Medicated Feeds for Minor Species.'' In advance of the January 1, 2017, date on which we anticipate that a number of drugs will convert from over-the-counter (OTC) to veterinary feed directive (VFD) status, this revised CPG clarifies policy and regulatory action guidance to FDA staff on the Agency's exercise of regulatory discretion with regard to the extralabel use of medicated feeds containing those drugs in minor species. DATES: The Agency is soliciting public comment, but is implementing this CPG immediately because the Agency has determined that prior public participation is not feasible or appropriate. You may submit either electronic or written comments on Agency guidances at any time. 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 [[Page 87567]] 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-1999-D-1875 for ``Compliance Policy Guide Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species.'' 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 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 CPG 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 request. See the SUPPLEMENTARY INFORMATION section for electronic access to the CPG. FOR FURTHER INFORMATION CONTACT: Amber McCoig, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5556, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The revised CPG is intended to clarify policy and regulatory action guidance to FDA staff on the Agency's exercise of regulatory discretion with regard to the extralabel use of medicated feed in minor species. We are implementing this CPG without prior public comment because we have determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)). Although this CPG is immediately in effect, it remains subject to comment in accordance with FDA's good guidance practices regulation. The treatment of minor species is especially challenging for two reasons. First, many minor species, such as fish and game birds, have very few drugs approved for their use. As a result, veterinarians often times have to treat these species in an extralabel manner, using drugs that are not approved for them. Further, some minor species cannot practically be medicated in any way other than through the use of medicated feeds. Because extralabel use of medicated feeds is not permitted, veterinarians face an additional challenge to prevent unnecessary suffering and death of minor species. In 2001, FDA published CPG 615.115 to provide guidance to FDA staff concerning the Agency's exercise of regulatory discretion with regard to the extralabel use of medicated feeds in minor species. The CPG was silent regarding the different marketing statuses of medicated feeds and did not explicitly address situations involving feeds containing VFD drugs. In the Federal Register of December 12, 2013, FDA announced Guidance for Industry (GFI) #213 entitled ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209'' (78 FR 75570). As a result of GFI #213, FDA anticipates that, beginning January 1, 2017, a number of drugs, including some drugs used in medicated feeds, will convert from OTC marketing status to VFD marketing status. As this conversion occurs, drugs that previously were available OTC for producers and veterinarians for use in medicated feed will become VFD drugs. Because the current CPG is silent regarding the different marketing statuses of medicated feeds, to avoid potential confusion and harm to minor species requiring treatment with certain drug products converting from OTC to VFD, the Agency has decided to revise CPG 615.115 to explicitly clarify our intent to exercise regulatory discretion over both OTC and VFD feeds. In order to inform stakeholders before January 1, 2017, of the Agency's expectations regarding the extralabel use of VFD feeds in minor species, we are implementing this CPG immediately. We are soliciting public comment on this CPG, but immediate implementation will give stakeholders the opportunity to operate under the provisions of this CPG before they submit comments. II. Significance of Guidance This CPG is being issued as a level 1 guidance for FDA staff consistent with FDA's good guidance practices regulation (21 CFR 10.115). The CPG represents the current thinking of FDA on the extralabel use of medicated feeds for minor species. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons with access to the Internet may obtain the CPG at either http://www.fda.gov/AnimalVeterinary/ [[Page 87568]] GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: November 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29133 Filed 12-2-16; 8:45 am] BILLING CODE 4164-01-P
![87566 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
made publicly available, submit your I. Background Dated: November 29, 2016.
comments only as a written/paper FDA is announcing the availability of Leslie Kux,
submission. You should submit two a revised guidance for industry entitled Associate Commissioner for Policy.
copies total. One copy will include the ‘‘Health Document Submission [FR Doc. 2016–29117 Filed 12–2–16; 8:45 am]
information you claim to be confidential Requirements for Tobacco Products.’’ BILLING CODE 4164–01–P
with a heading or cover note that states The revised guidance includes
‘‘THIS DOCUMENT CONTAINS guidance for manufacturers or importers
CONFIDENTIAL INFORMATION.’’ The of newly deemed tobacco products that DEPARTMENT OF HEALTH AND
Agency will review this copy, including are subject to chapter IX of the Federal HUMAN SERVICES
the claimed confidential information, in Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 387). Cigarettes, Food and Drug Administration
its consideration of comments. The
second copy, which will have the cigarette tobacco, roll-your-own, and [Docket No. FDA–1999–D–1875]
claimed confidential information smokeless tobacco were immediately
redacted/blacked out, will be available subject to chapter IX of the FD&C Act, Compliance Policy Guide Sec. 615.115
for public viewing and posted on http:// including section 904(a)(4), which on Extralabel Use of Medicated Feeds
www.regulations.gov. Submit both requires the submission of certain for Minor Species; Availability
copies to the Division of Dockets health documents. Section 901(b) of the AGENCY: Food and Drug Administration,
Management. If you do not wish your FD&C Act grants FDA authority to deem HHS.
all other tobacco products subject to
name and contact information to be ACTION: Notice of availability.
chapter IX of the FD&C Act as well.
made publicly available, you can
Pursuant to that authority, FDA issued SUMMARY: The Food and Drug
provide this information on the cover
a final rule deeming all other products Administration (FDA or Agency) is
sheet and not in the body of your that meet the statutory definition of
comments and you must identify this announcing the availability of a revised
‘‘tobacco product,’’ set forth in section Compliance Policy Guide (CPG) 615.115
information as ‘‘confidential.’’ Any 201(rr) of the FD&C Act (21 U.S.C. entitled ‘‘Extralabel Use of Medicated
information marked as ‘‘confidential’’ 321(rr)), except for accessories of those Feeds for Minor Species.’’ In advance of
will not be disclosed except in products, subject to the Chapter IX of the January 1, 2017, date on which we
accordance with 21 CFR 10.20 and other the FD&C Act (81 FR 28973). FDA anticipate that a number of drugs will
applicable disclosure law. For more published the final rule on May 10, convert from over-the-counter (OTC) to
information about FDA’s posting of 2016 (81 FR 28973) and it became veterinary feed directive (VFD) status,
comments to public dockets, see 80 FR effective on August 8, 2016. Therefore, this revised CPG clarifies policy and
56469, September 18, 2015, or access manufacturers and importers of such regulatory action guidance to FDA staff
the information at: http://www.fda.gov/ tobacco products are now required to on the Agency’s exercise of regulatory
regulatoryinformation/dockets/ comply with chapter IX of the FD&C discretion with regard to the extralabel
default.htm. Act, including section 904(a)(4). use of medicated feeds containing those
Docket: For access to the docket to II. Significance of Guidance drugs in minor species.
read background documents or the FDA is issuing this guidance DATES: The Agency is soliciting public
electronic and written/paper comments consistent with FDA’s good guidance comment, but is implementing this CPG
received, go to http:// practices regulation (21 CFR 10.115). immediately because the Agency has
www.regulations.gov and insert the The guidance represents the current determined that prior public
docket number, found in brackets in the thinking of FDA on health document participation is not feasible or
heading of this document, into the submission requirements. It does not appropriate. You may submit either
‘‘Search’’ box and follow the prompts establish any rights for any person and electronic or written comments on
and/or go to the Division of Dockets is not binding on FDA or the public. Agency guidances at any time.
Management, 5630 Fishers Lane, Rm. You can use an alternative approach if ADDRESSES: You may submit comments
1061, Rockville, MD 20852. it satisfies the requirements of the as follows:
Submit written requests for single applicable statutes and regulations. Electronic Submissions
copies of the guidance to the Center for III. Paperwork Reduction Act of 1995 Submit electronic comments in the
Tobacco Products, Food and Drug following way:
Administration, 10903 New Hampshire This guidance also refers to
previously approved collections of • Federal eRulemaking Portal:
Ave., Document Control Center, Bldg. https://www.regulations.gov/. Follow
information found in FDA statute. The
71, Rm. G335, Silver Spring, MD 20993– the instructions for submitting
guidance includes information and
0002. Send two self-addressed adhesive comments. Comments submitted
recommendations for how to provide
labels to assist that office in processing electronically, including attachments, to
health document submissions. The
your requests. See the SUPPLEMENTARY collections of information in section 904 https://www.regulations.gov/ will be
INFORMATION section for electronic posted to the docket unchanged.
(a)(4) of the FD&C Act have been
access to the guidance document. approved under OMB control number Because your comment will be made
FOR FURTHER INFORMATION CONTACT: 0910–0654. public, you are solely responsible for
Katherine Collins, Center for Tobacco ensuring that your comment does not
IV. Electronic Access include any confidential information
sradovich on DSK3GMQ082PROD with NOTICES
Products, Food and Drug
Administration, 10903 New Hampshire Persons with access to the Internet that you or a third party may not wish
Ave., Document Control Center, Bldg. may obtain an electronic version of the to be posted, such as medical
71, Rm. G335, Silver Spring, MD 20993– guidance at either http:// information, your or anyone else’s
www.regulations.gov or http:// Social Security number, or confidential
0002, 1–877–287–1373, email: AskCTP@
www.fda.gov/TobaccoProducts/ business information, such as a
fda.hhs.gov.
Labeling/RulesRegulationsGuidance/ manufacturing process. Please note that
SUPPLEMENTARY INFORMATION: default.htm. if you include your name, contact
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![87568 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
GuidanceComplianceEnforcement/ third party may not wish to be posted, made publicly available, you can
GuidanceforIndustry/default.htm or such as medical information, your or provide this information on the cover
http://www.regulations.gov. anyone else’s Social Security number, or sheet and not in the body of your
Dated: November 18, 2016. confidential business information, such comments and you must identify this
Leslie Kux,
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
Associate Commissioner for Policy.
information, or other information that will not be disclosed except in
[FR Doc. 2016–29133 Filed 12–2–16; 8:45 am] identifies you in the body of your accordance with 21 CFR 10.20 and other
BILLING CODE 4164–01–P comments, that information will be applicable disclosure law. For more
posted on https://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
DEPARTMENT OF HEALTH AND with confidential information that you 56469, September 18, 2015, or access
HUMAN SERVICES do not wish to be made available to the the information at: http://www.fda.gov/
public, submit the comment as a regulatoryinformation/dockets/
Food and Drug Administration
written/paper submission and in the default.htm.
[Docket Nos. FDA–2016–E–0617; FDA– manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
2016–E–0619] Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
Determination of Regulatory Review
received, go to https://
Period for Purposes of Patent Submit written/paper submissions as www.regulations.gov and insert the
Extension; BEXSERO follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, heading of this document, into the
written/paper submissions): Division of
HHS. ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
ACTION: Notice. and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments 1061, Rockville, MD 20852.
Administration (FDA) has determined submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
the regulatory review period for Management, FDA will post your Beverly Friedman, Office of Regulatory
BEXSERO and is publishing this notice comment, as well as any attachments, Policy, Food and Drug Administration,
of that determination as required by except for information submitted, 10903 New Hampshire Ave., Bldg. 51,
law. FDA has made the determination marked and identified, as confidential, Rm. 6250, Silver Spring, MD 20993,
because of the submission of if submitted as detailed in 301–796–3600.
applications to the Director of the U.S. ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
Patent and Trademark Office (USPTO), Instructions: All submissions received
Department of Commerce, for the must include the Docket Nos. FDA– I. Background
extension of a patent which claims that 2016–E–0617 and FDA–2016–E–0619 The Drug Price Competition and
human biological product. for ‘‘Determination of Regulatory Patent Term Restoration Act of 1984
DATES: Anyone with knowledge that any Review Period for Purposes of Patent (Pub. L. 98–417) and the Generic
of the dates as published (see the Extension; BEXSERO.’’ Received Animal Drug and Patent Term
SUPPLEMENTARY INFORMATION section) are comments will be placed in the docket Restoration Act (Pub. L. 100–670)
incorrect may submit either electronic and, except for those submitted as generally provide that a patent may be
or written comments and ask for a ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years
redetermination by February 3, 2017. viewable at https://www.regulations.gov so long as the patented item (human
Furthermore, any interested person may or at the Division of Dockets drug product, animal drug product,
petition FDA for a determination Management between 9 a.m. and 4 p.m., medical device, food additive, or color
regarding whether the applicant for Monday through Friday. additive) was subject to regulatory
extension acted with due diligence • Confidential Submissions—To review by FDA before the item was
during the regulatory review period by submit a comment with confidential marketed. Under these acts, a product’s
June 5, 2017. See ‘‘Petitions’’ in the information that you do not wish to be regulatory review period forms the basis
SUPPLEMENTARY INFORMATION section for made publicly available, submit your for determining the amount of extension
more information. comments only as a written/paper an applicant may receive.
ADDRESSES: You may submit comments submission. You should submit two A regulatory review period consists of
as follows: copies total. One copy will include the two periods of time: A testing phase and
information you claim to be confidential an approval phase. For human
Electronic Submissions with a heading or cover note that states biological products, the testing phase
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit
following way: CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the
• Federal eRulemaking Portal: Agency will review this copy, including biological product becomes effective
https://www.regulations.gov. Follow the the claimed confidential information, in and runs until the approval phase
instructions for submitting comments. its consideration of comments. The begins. The approval phase starts with
Comments submitted electronically, second copy, which will have the the initial submission of an application
sradovich on DSK3GMQ082PROD with NOTICES
including attachments, to https:// claimed confidential information to market the human biological product
www.regulations.gov will be posted to redacted/blacked out, will be available and continues until FDA grants
the docket unchanged. Because your for public viewing and posted on permission to market the biological
comment will be made public, you are https://www.regulations.gov. Submit product. Although only a portion of a
solely responsible for ensuring that your both copies to the Division of Dockets regulatory review period may count
comment does not include any Management. If you do not wish your toward the actual amount of extension
confidential information that you or a name and contact information to be that the Director of USPTO may award
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Document Created: 2016-12-03 00:26:28
Document Modified: 2016-12-03 00:26:28
| 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 | The Agency is soliciting public comment, but is implementing this CPG immediately because the Agency has determined that prior public participation is not feasible or appropriate. You may submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Amber McCoig, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5556, [email protected] | |
| FR Citation | 81 FR 87566 |
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