83 FR 30534 - Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 126 (June 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 126 (June 29, 2018)
| Page Range | 30534-30535 | |
| FR Document | 2018-14085 |
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)] [Rules and Regulations] [Pages 30534-30535] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14085] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2012-N-0447] Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry #252 entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule we issued in the Federal Register of May 11, 2016, entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting.'' DATES: The announcement of the guidance is published in the Federal Register on June 29, 2018. 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-2012-N-0447 for ``Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide.'' 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.'' We will review this copy, including the claimed confidential information, in our 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 [[Page 30535]] 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: https://www.thefederalregister.org/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 SECG to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5671, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), as amended by section 105 of the Animal Drug Use Fee Amendments of 2008 (ADUFA 105) (Pub. L. 110-316), to submit to us an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. We are also required by ADUFA 105 to publish annual summary reports of the data we receive from animal drug sponsors. In accordance with the law, sponsors of the affected antimicrobial new animal drug products began submitting their sales and distribution data to us on an annual basis, and we have published summaries of such data for each calendar year beginning with 2009. In the Federal Register of May 11, 2016 (81 FR 29129), we published a final rule entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting'' that amended our existing records and reports regulation in part 514 (21 CFR part 514) to incorporate the sales and distribution data reporting requirements specific to antimicrobial new animal drugs that were added to the FD&C Act by ADUFA 105. The rule also added an additional reporting provision intended to improve our understanding of antimicrobial animal drug sales intended for use in specific food-producing animal species. In accordance with the new rule, the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient must submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. The final rule, which is codified at Sec. Sec. 514.80 and 514.87, became effective July 11, 2016. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will not have a significant economic impact on a substantial number of small entities (81 FR 29129 at 29138). Nonetheless, we determined not to certify that finding due to the remote possibility that, in the future, a very small company could enter the market and sponsor an application for an antimicrobial new animal drug product that would be sold or distributed for use in food- producing animals. Thus, in compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-28), we are making available this SECG to explain the actions that a potential future market entrant small entity must take to comply with the rule. We are issuing this SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the current thinking of FDA on this topic. 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 is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in Sec. 514.87 have been approved under OMB control number 0910-0659. The collections of information in Sec. 514.80 have been approved under OMB control number 0910-0284. III. Electronic Access Persons with access to the internet may obtain the SECG at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: June 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14085 Filed 6-28-18; 8:45 am] BILLING CODE 4164-01-P
![30534 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Rules and Regulations
Commodity Exchange Act, as added by any related foreign futures or foreign comment does not include any
the Dodd-Frank Wall Street Reform and options secured amount carried in the confidential information that you or a
Consumer Protection Act. That account(s) of a foreign futures or foreign third party may not wish to be posted,
document inadvertently failed to options customer. such as medical information, your or
remove several obsolete provisions in * * * * * anyone else’s Social Security number, or
§ 1.33(a)(2) and (b)(3). Accordingly, the (b) * * * confidential business information, such
Commission is making a correcting (3) A written confirmation of each as a manufacturing process. Please note
amendment to § 1.33 that removes the commodity option transaction, that if you include your name, contact
second paragraph (a)(2)(ii), removes containing at least the following information, or other information that
paragraph (a)(2)(v), and removes the information: identifies you in the body of your
introductory clause to paragraph (b)(3). comments, that information will be
* * * * *
posted on https://www.regulations.gov.
List of Subjects in 17 CFR Part 1 Dated: June 15, 2018. • If you want to submit a comment
Agricultural commodity, Agriculture, Robert N. Sidman, with confidential information that you
Brokers, Committees, Commodity Deputy Secretary of the Commission. do not wish to be made available to the
futures, Conflicts of interest, Consumer [FR Doc. 2018–13256 Filed 6–28–18; 8:45 am] public, submit the comment as a
protection, Definitions, Designated BILLING CODE 6351–01–P
written/paper submission and in the
contract markets, Directors, Major swap manner detailed (see ‘‘Written/Paper
participants, Minimum financial Submissions’’ and ‘‘Instructions’’).
requirements for intermediaries, DEPARTMENT OF HEALTH AND Written/Paper Submissions
Reporting and recordkeeping HUMAN SERVICES
requirements, Swap dealers, Swaps. Submit written/paper submissions as
follows:
Accordingly, 17 CFR part 1 is Food and Drug Administration • Mail/Hand Delivery/Courier (for
corrected by making the following written/paper submissions): Dockets
correcting amendments: 21 CFR Part 514 Management Staff (HFA–305), Food and
PART 1—GENERAL REGULATIONS [Docket No. FDA–2012–N–0447] Drug Administration, 5630 Fishers
UNDER THE COMMODITY EXCHANGE Lane, Rm. 1061, Rockville, MD 20852.
Antimicrobial Animal Drug Sales and • For written/paper comments
ACT
Distribution Reporting; Small Entity submitted to the Dockets Management
■ 1. The authority citation for part 1 Compliance Guide; Availability Staff, FDA will post your comment, as
continues to read as follows: well as any attachments, except for
AGENCY: Food and Drug Administration, information submitted, marked and
Authority: 7 U.S.C. 1a, 2, 5, 6, 6a, 6b, 6c, HHS. identified, as confidential, if submitted
6d, 6e, 6f, 6g, 6h, 6i, 6k, 6l, 6m, 6n, 6o, 6p, ACTION: Notification of availability.
6r, 6s, 7, 7a-1, 7a-2, 7b, 7b-3, 8, 9, 10a, 12, as detailed in ‘‘Instructions.’’
12a, 12c, 13a, 13a-1, 16, 16a, 19, 21, 23, and Instructions: All submissions received
SUMMARY: The Food and Drug must include the Docket No. FDA–
24 (2012). Administration (FDA, the Agency, or
■ 2. Amend § 1.33 as follows: 2012–N–0447 for ‘‘Antimicrobial
we) is announcing the availability of a Animal Drug Sales and Distribution
■ a. Revise paragraph (a)(2); and final guidance for industry #252 entitled
■ b. Revise paragraph (b)(3) Reporting; Small Entity Compliance
‘‘Antimicrobial Animal Drug Sales and Guide.’’ Received comments will be
introductory text. Distribution Reporting Small Entity
The revisions read as follows: placed in the docket and, except for
Compliance Guide.’’ The small entity those submitted as ‘‘Confidential
§ 1.33 Monthly and confirmation compliance guide (SECG) is intended to Submissions,’’ publicly viewable at
statements. help small entities comply with the https://www.regulations.gov or at the
(a) * * * final rule we issued in the Federal Dockets Management Staff between 9
(2) For each commodity option Register of May 11, 2016, entitled a.m. and 4 p.m., Monday through
position and foreign option position— ‘‘Antimicrobial Animal Drug Sales and Friday.
(i) All commodity options and foreign Distribution Reporting.’’ • Confidential Submissions—To
options purchased, sold, exercised, or DATES: The announcement of the submit a comment with confidential
expired during the monthly reporting guidance is published in the Federal information that you do not wish to be
period, identified by underlying futures Register on June 29, 2018. made publicly available, submit your
contract or underlying commodity, ADDRESSES: You may submit either comments only as a written/paper
strike price, transaction date, and electronic or written comments on submission. You should submit two
expiration date; Agency guidances at any time as copies total. One copy will include the
(ii) The open commodity option and follows: information you claim to be confidential
foreign option positions carried for such with a heading or cover note that states
customer or foreign futures or foreign Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
options customer as of the end of the Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ We
monthly reporting period, identified by following way: will review this copy, including the
underlying futures contract or • Federal eRulemaking Portal: claimed confidential information, in our
underlying commodity, strike price, https://www.regulations.gov. Follow the consideration of comments. The second
sradovich on DSK3GMQ082PROD with RULES
transaction date, and expiration date; instructions for submitting comments. copy, which will have the claimed
(iii) All open commodity option and Comments submitted electronically, confidential information redacted/
foreign option positions marked to the including attachments, to https:// blacked out, will be available for public
market and the amount each position is www.regulations.gov will be posted to viewing and posted on https://
in the money, if any; and the docket unchanged. Because your www.regulations.gov. Submit both
(iv) Any related customer funds comment will be made public, you are copies to the Dockets Management Staff.
carried in such customer’s account(s) or solely responsible for ensuring that your If you do not wish your name and
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![Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Rules and Regulations 30535
contact information to be made publicly annual basis, and we have published II. Paperwork Reduction Act of 1995
available, you can provide this summaries of such data for each This guidance refers to previously
information on the cover sheet and not calendar year beginning with 2009. approved collections of information
in the body of your comments and you In the Federal Register of May 11, found in FDA regulations. These
must identify this information as 2016 (81 FR 29129), we published a collections of information are subject to
‘‘confidential.’’ Any information marked final rule entitled ‘‘Antimicrobial review by the Office of Management and
as ‘‘confidential’’ will not be disclosed Animal Drug Sales and Distribution Budget (OMB) under the Paperwork
except in accordance with 21 CFR 10.20 Reporting’’ that amended our existing Reduction Act of 1995 (44 U.S.C. 3501–
and other applicable disclosure law. For records and reports regulation in part 3520). The collections of information in
more information about FDA’s posting 514 (21 CFR part 514) to incorporate the § 514.87 have been approved under
of comments to public dockets, see 80 sales and distribution data reporting OMB control number 0910–0659. The
FR 56469, September 18, 2015, or access requirements specific to antimicrobial collections of information in § 514.80
the information at: https://www.gpo.gov/ new animal drugs that were added to have been approved under OMB control
fdsys/pkg/FR-2015-09-18/pdf/2015- the FD&C Act by ADUFA 105. The rule number 0910–0284.
23389.pdf. also added an additional reporting
Docket: For access to the docket to III. Electronic Access
provision intended to improve our
read background documents or the Persons with access to the internet
understanding of antimicrobial animal
electronic and written/paper comments may obtain the SECG at either https://
drug sales intended for use in specific
received, go to https:// www.fda.gov/AnimalVeterinary/
food-producing animal species. In
www.regulations.gov and insert the GuidanceComplianceEnforcement/
accordance with the new rule, the
docket number, found in brackets in the GuidanceforIndustry/default.htm or
sponsor of each approved or
heading of this document, into the https://www.regulations.gov.
conditionally approved new animal
‘‘Search’’ box and follow the prompts
drug product that contains an Dated: June 26, 2018.
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, antimicrobial active ingredient must Leslie Kux,
Rockville, MD 20852. submit an annual report to us on the Associate Commissioner for Policy.
You may submit comments on any amount of each such ingredient in the [FR Doc. 2018–14085 Filed 6–28–18; 8:45 am]
guidance at any time (see 21 CFR drug product that is sold or distributed BILLING CODE 4164–01–P
10.115(g)(5)). for use in food-producing animals,
Submit written requests for single including information on any
copies of the SECG to the Policy and distributor-labeled product. The final
DEPARTMENT OF THE TREASURY
Regulations Staff (HFV–6), Center for rule, which is codified at §§ 514.80 and
Veterinary Medicine, Food and Drug 514.87, became effective July 11, 2016. Alcohol and Tobacco Tax and Trade
Administration, 7500 Standish Pl., We examined the economic Bureau
Rockville, MD 20855. Send two self- implications of the final rule as required
addressed adhesive labels to assist that by the Regulatory Flexibility Act (5 27 CFR Part 9
office in processing your request. See U.S.C. 601–612) and determined that [Docket No. TTB–2016–0012; T.D. TTB–151;
the SUPPLEMENTARY INFORMATION section the final rule will not have a significant Ref: Notice No. 166]
for electronic access to the SECG. economic impact on a substantial
number of small entities (81 FR 29129 RIN 1513–AC33
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary at 29138). Nonetheless, we determined
Establishment of the Dahlonega
Medicine (HFV–212), Food and Drug not to certify that finding due to the
Plateau Viticultural Area
Administration, 7519 Standish Pl., remote possibility that, in the future, a
Rockville, MD 20855, 240–402–5671, very small company could enter the AGENCY: Alcohol and Tobacco Tax and
sujaya.dessai@fda.hhs.gov. market and sponsor an application for Trade Bureau, Treasury.
SUPPLEMENTARY INFORMATION:
an antimicrobial new animal drug ACTION: Final rule; Treasury decision.
product that would be sold or
I. Background distributed for use in food-producing SUMMARY: The Alcohol and Tobacco Tax
Sponsors of approved or conditionally animals. Thus, in compliance with and Trade Bureau (TTB) establishes the
approved applications for new animal section 212 of the Small Business approximately 133-square mile
drugs containing an antimicrobial active Regulatory Enforcement Fairness Act Dahlonega Plateau viticultural area in
ingredient are required by section 512 of (Pub. L. 104–121, as amended by Pub. portions of Lumpkin and White
the Federal Food, Drug, and Cosmetic L. 110–28), we are making available this counties in Georgia. The Dahlonega
Act (FD&C Act) (21 U.S.C. 360b), as SECG to explain the actions that a Plateau viticultural area is not located
amended by section 105 of the Animal potential future market entrant small within any other established viticultural
Drug Use Fee Amendments of 2008 entity must take to comply with the area. TTB designates viticultural areas
(ADUFA 105) (Pub. L. 110–316), to rule. to allow vintners to better describe the
submit to us an annual report on the We are issuing this SECG consistent origin of their wines and to allow
amount of each such ingredient in the with our good guidance practices consumers to better identify wines they
drug that is sold or distributed for use regulation (21 CFR 10.115(c)(2)). The may purchase.
in food-producing animals. We are also SECG represents the current thinking of DATES: This final rule is effective July
sradovich on DSK3GMQ082PROD with RULES
required by ADUFA 105 to publish FDA on this topic. It does not establish 30, 2018.
annual summary reports of the data we any rights for any person and is not FOR FURTHER INFORMATION CONTACT:
receive from animal drug sponsors. In binding on FDA or the public. You can Dana Register, Regulations and Rulings
accordance with the law, sponsors of use an alternative approach if it satisfies Division, Alcohol and Tobacco Tax and
the affected antimicrobial new animal the requirements of the applicable Trade Bureau, 1310 G Street NW, Box
drug products began submitting their statutes and regulations. This guidance 12, Washington, DC 20005; phone 202–
sales and distribution data to us on an is not subject to Executive Order 12866. 453–1039, ext. 022.
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Document Created: 2018-06-29 01:13:13
Document Modified: 2018-06-29 01:13:13
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on June 29, 2018. | |
| Contact | Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5671, [email protected] | |
| FR Citation | 83 FR 30534 |
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