83 FR 56854 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Levels and Withdrawal Periods; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 220 (November 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 220 (November 14, 2018)
| Page Range | 56854-56856 | |
| FR Document | 2018-24762 |
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)] [Notices] [Pages 56854-56856] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24762] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-4461] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Levels and Withdrawal Periods; 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 final guidance for industry (GFI) #243 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration or approval purposes, as applicable, when an MRL already exists. DATES: The announcement of the guidance is published in the Federal Register on November 14, 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-2016-D-4461 for ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56). 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 [[Page 56855]] 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 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: Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0788, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of final GFI #243 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for several years to develop, with input from both regulatory and industry representatives, harmonized technical requirements for the registration or approval of pharmaceutical products for human use among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; International Federation for Animal Health--Europe; FDA; the U.S. Department of Agriculture; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry, and Fisheries; and the Japanese Veterinary Products Association. Six observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, one representative from the industry in Canada, one representative from the government of South Africa, and one representative from the industry in South Africa. The World Organisation for Animal Health, the Associate Member, has one delegate. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals. In the Federal Register of January 5, 2017 (82 FR 1342), FDA published the notice of availability for a draft guidance entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56), giving interested persons until March 6, 2017, to comment on the draft guidance. FDA received two comments on the draft guidance, and those comments, as well as those received by other VICH member regulatory agencies, were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated January 2017. The final guidance is a product of the Metabolism and Residue Kinetics Expert Working Group of the VICH. This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate MRLs or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration or approval purposes, as applicable, when an MRL already exists. II. Significance of Guidance This guidance, developed under the VICH process, is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated ``guidance'' rather than ``guideline.'' In addition, guidance documents must not include mandatory language such as ``shall,'' ``must,'' ``require,'' or ``requirement,'' unless FDA is using these words to describe a statutory or regulatory requirement. The guidance represents the current thinking of FDA on ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56). 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. III. 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 21 CFR part 514 have been approved under OMB control number 0910-0032. IV. 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. [[Page 56856]] Dated: November 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24762 Filed 11-13-18; 8:45 am] BILLING CODE 4164-01-P
![56854 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA form No. responses per burden per Total hours
respondents responses
respondent response
FDA 3602—MDUFA Small Business Certification Request
For a Business Headquartered in the United States ....... 5,000 1 5,000 1 5,000
FDA 3602A—MDUFA Foreign Small Business Certification
Request For a Business Headquartered Outside the
United States .................................................................... 2,000 1 2,000 1 2,000
Total .............................................................................. ........................ ........................ ........................ ........................ 7,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the recommendations that will facilitate the Written/Paper Submissions
information collection reflects an universal acceptance of the generated Submit written/paper submissions as
overall increase of 2,000 hours and a residue depletion data to fulfill the follows:
corresponding increase of 2,000 national/regional requirements in order • Mail/Hand delivery/Courier (for
responses. We attribute this adjustment to establish appropriate Maximum written/paper submissions): Dockets
to an increase in the number of Residue Limits (MRLs) or other safe Management Staff (HFA–305), Food and
submissions we received over the last limits in honey following the treatment Drug Administration, 5630 Fishers
few years. of honeybees with veterinary drug Lane, Rm. 1061, Rockville, MD 20852.
Dated: November 7, 2018. products, or to justify withdrawal • For written/paper comments
Leslie Kux, periods in honey for registration or submitted to the Dockets Management
Associate Commissioner for Policy.
approval purposes, as applicable, when Staff, FDA will post your comment, as
an MRL already exists. well as any attachments, except for
[FR Doc. 2018–24790 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P DATES: The announcement of the information submitted, marked and
guidance is published in the Federal identified, as confidential, if submitted
Register on November 14, 2018. as detailed in ‘‘Instructions.’’
DEPARTMENT OF HEALTH AND Instructions: All submissions received
HUMAN SERVICES ADDRESSES: You may submit either must include the Docket No. FDA–
electronic or written comments on 2016–D–4461 for ‘‘Studies to Evaluate
Food and Drug Administration Agency guidances at any time as the Metabolism and Residue Kinetics of
follows: Veterinary Drugs in Food-Producing
[Docket No. FDA–2016–D–4461] Species: Study Design
Electronic Submissions
Recommendations for Residue Studies
International Cooperation on
Submit electronic comments in the in Honey for Establishing MRLs and
Harmonisation of Technical
following way: Withdrawal Periods’’ (VICH GL56).
Requirements for Registration of
Received comments will be placed in
Veterinary Medicinal Products; Study • Federal eRulemaking Portal:
the docket and, except for those
Design Recommendations for Residue https://www.regulations.gov. Follow the
submitted as ‘‘Confidential
Studies in Honey for Establishing instructions for submitting comments.
Submissions,’’ publicly viewable at
Maximum Residue Levels and Comments submitted electronically,
https://www.regulations.gov or at the
Withdrawal Periods; Guidance for including attachments, to https://
Dockets Management Staff between 9
Industry; Availability www.regulations.gov will be posted to a.m. and 4 p.m., Monday through
the docket unchanged. Because your Friday.
AGENCY: Food and Drug Administration,
comment will be made public, you are • Confidential Submissions—To
HHS.
solely responsible for ensuring that your submit a comment with confidential
ACTION: Notice of availability. comment does not include any information that you do not wish to be
SUMMARY: The Food and Drug confidential information that you or a made publicly available, submit your
Administration (FDA or Agency) is third party may not wish to be posted, comments only as a written/paper
announcing the availability of a final such as medical information, your or submission. You should submit two
guidance for industry (GFI) #243 anyone else’s Social Security number, or copies total. One copy will include the
entitled ‘‘Studies to Evaluate the confidential business information, such information you claim to be confidential
Metabolism and Residue Kinetics of as a manufacturing process. Please note with a heading or cover note that states
Veterinary Drugs in Food-Producing that if you include your name, contact ‘‘THIS DOCUMENT CONTAINS
Species: Study Design information, or other information that CONFIDENTIAL INFORMATION.’’ The
Recommendations for Residue Studies identifies you in the body of your Agency will review this copy, including
in Honey for Establishing MRLs and comments, that information will be the claimed confidential information, in
Withdrawal Periods’’ (VICH GL56). This posted on https://www.regulations.gov. its consideration of comments. The
guidance has been developed for • If you want to submit a comment second copy, which will have the
veterinary use by the International with confidential information that you claimed confidential information
Cooperation on Harmonisation of do not wish to be made available to the redacted/blacked out, will be available
Technical Requirements for Registration public, submit the comment as a for public viewing and posted on
of Veterinary Medicinal Products written/paper submission and in the https://www.regulations.gov. Submit
(VICH). This VICH guidance document manner detailed (see ‘‘Written/Paper both copies to the Dockets Management
is intended to provide study design Submissions’’ and ‘‘Instructions’’). Staff. If you do not wish your name and
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![56856 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
Dated: November 7, 2018. (FD&C Act) (see 21 U.S.C. 321(f)), Health Warning Statement under the
Leslie Kux, includes ‘‘articles used for food or Alcoholic Beverage Labeling Act and
Associate Commissioner for Policy. drink’’ and thus includes alcoholic certain marking requirements under the
[FR Doc. 2018–24762 Filed 11–13–18; 8:45 am] beverages. As such, alcoholic beverages Internal Revenue Code, continue to
BILLING CODE 4164–01–P are subject to the FD&C Act’s apply to these products.
adulteration and misbranding Persons with access to the internet
provisions and implementing may obtain the guidance entitled,
DEPARTMENT OF HEALTH AND regulations related to food. For example, ‘‘Labeling of Certain Beers Subject to the
HUMAN SERVICES manufacturers of alcoholic beverages are Labeling Jurisdiction of the Food and
responsible for adhering to the Drug Administration,’’ located at
Food and Drug Administration registration of food facilities https://www.fda.gov/FoodGuidances.
[Docket No. FDA–2009–D–0268] requirements in 21 CFR part 1 and to This guidance is intended to assist
the good manufacturing practice manufacturers on how to label bottled
Agency Information Collection regulations in 21 CFR part 110. There or otherwise packaged beers that are
Activities; Submission for Office of are also certain requirements for subject to our labeling laws and
Management and Budget Review; nutrition labeling on menus, menu regulations.
Comment Request; Labeling of Certain boards, and other written materials for Our food labeling regulations under
Beers Subject to the Labeling alcohol beverages served in restaurants parts 101, 102, 104, and 105 (21 CFR
Jurisdiction of the Food and Drug or similar retail food establishments in parts 101, 102, 104, and 105) were
Administration 21 CFR part 101. However, as reflected issued under the authority of sections 4,
in a 1987 Memorandum of 5, and 6 of the FPLA (15 U.S.C. 1453,
AGENCY: Food and Drug Administration, Understanding between FDA and the 1454, and 1455) and under sections 201,
HHS. Alcohol and Tobacco Tax and Trade 301, 402, 403, 409, 411, 701, and 721 of
ACTION: Notice. Bureau (TTB), TTB is responsible for the the FD&C Act (21 U.S.C. 321, 331, 342,
dissemination and enforcement of 343, 348, 350, 371, and 379e). Most of
SUMMARY: The Food and Drug these regulations derive from section
regulations with respect to the labeling
Administration (FDA) is announcing 403 of the FD&C Act, which provides
of distilled spirits, certain wines, and
that a proposed collection of that a food product shall be deemed to
malt beverages issued in the Federal
information has been submitted to the be misbranded if, among other things,
Alcohol Administration Act (FAA Act).
Office of Management and Budget its label or labeling fails to bear certain
In TTB Ruling 2008–3, dated July 7,
(OMB) for review and clearance under required information concerning the
2008, TTB clarified that certain beers,
the Paperwork Reduction Act of 1995. which are not made from both malted food product, is false or misleading in
DATES: Fax written comments on the barley and hops but are instead made any particular, or bears certain types of
collection of information by December from substitutes for malted barley (such unauthorized claims. The disclosure
14, 2018. as sorghum, rice, or wheat) or are made requirements and other collections of
ADDRESSES: To ensure that comments on without hops, do not meet the definition information in the regulations in parts
the information collection are received, of a ‘‘malt beverage’’ under the FAA 101, 102, 104, and 105 are necessary to
OMB recommends that written Act. Accordingly, TTB stated in its ensure that food products produced or
comments be faxed to the Office of ruling that such products (other than sold in the United States are in
Information and Regulatory Affairs, saké, which is classified as a wine under compliance with the labeling provisions
OMB, Attn: FDA Desk Officer, Fax: 202– the FAA Act), are not subject to the of the FD&C Act and the FPLA.
395–7285, or emailed to oira_ labeling, advertising, or other provisions The primary user of the information
submission@omb.eop.gov. All of TTB regulations issued under the to be disclosed on the label or labeling
comments should be identified with the FAA Act. of food products is the consumer that
OMB control number 0910–0728. Also In cases where an alcoholic beverage purchases the food product. Consumers
include the FDA docket number found is not covered by the labeling provisions will use the information to assist them
in brackets in the heading of this of the FAA Act, the product is subject in making choices concerning their
document. to ingredient and other labeling purchase of a food product, including
requirements under the FD&C Act and choices related to substances that the
FOR FURTHER INFORMATION CONTACT:
the implementing regulations that we consumer must avoid to prevent adverse
JonnaLynn Capezzuto, Office of
administer. In addition, as provided for reactions. This information also enables
Operations, Food and Drug
under the Fair Packaging and Labeling the consumer to determine the role of
Administration, Three White Flint
Act (FPLA), alcoholic beverages that are the food product in a healthful diet.
North, 10A–12M, 11601 Landsdown St.,
not covered by the labeling provisions Additionally, FDA intends to use the
North Bethesda, MD 20852, 301–796–
of the FAA Act are subject to the information to determine whether a
3794, PRAStaff@fda.hhs.gov.
provisions of the FPLA, which we manufacturer or other supplier of food
SUPPLEMENTARY INFORMATION: In products is meeting its statutory and
administer.
compliance with 44 U.S.C. 3507, FDA Therefore, the beers described in regulatory obligations. Failure of a
has submitted the following proposed TTB’s ruling as not being a ‘‘malt manufacturer or other supplier of food
collection of information to OMB for beverage’’ are subject to the labeling products to label its products in
review and clearance. requirements under the FD&C Act and compliance with section 403 of the
Labeling of Certain Beers Subject to the FPLA, and our implementing FD&C Act and parts 101, 102, 104, and
Labeling Jurisdiction of the Food and regulations. In general, we require that 105 of FDA’s food labeling regulations
Drug Administration food products under our jurisdiction be may result in a product being
truthfully and informatively labeled in misbranded under the FD&C Act,
OMB Control Number 0910–0728— accordance with the FD&C Act, the subjecting the firm and product to
Extension FPLA, and FDA’s regulations. regulatory action.
The definition of ‘‘food’’ under the Furthermore, some TTB labeling Description of Respondents: The
Federal Food, Drug, and Cosmetic Act requirements, such as the Government respondents to this collection of
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Document Created: 2018-11-14 03:32:21
Document Modified: 2018-11-14 03:32:21
| 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 announcement of the guidance is published in the Federal Register on November 14, 2018. | |
| Contact | Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0788, [email protected] | |
| FR Citation | 83 FR 56854 |
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