80 FR 31041 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish an Acute Reference Dose; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 104 (June 1, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 104 (June 1, 2015)
| Page Range | 31041-31042 | |
| FR Document | 2015-13105 |
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)] [Notices] [Pages 31041-31042] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13105] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-1804] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish an Acute Reference Dose; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #232 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)'' (VICH GL54). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to address the nature and types of data that can be useful in determining an ARfD for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 31, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.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 request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tong Zhou, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0826, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #232 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)'' (VICH GL54). 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 has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. 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 Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products 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; European Medicines Evaluation Agency; European Federation of Animal Health; Committee on Veterinary Medicinal Products; FDA; the U.S. Department of Agriculture; the Animal Health Institute; the Japanese Veterinary Pharmaceutical Association; the Japanese Association of Veterinary Biologics; and the Japanese Ministry of Agriculture, Forestry, and Fisheries. 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 [[Page 31042]] representative from the government of Canada, one representative from the industry of Canada, one representative from the government of South Africa, and one representative from the industry of South Africa. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings. II. Draft Guidance on Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish an Acute Reference Dose (ARfD) The VICH Steering Committee held a meeting in February 2015 and agreed that the draft guidance document entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)'' (VICH GL54) should be made available for public comment. This draft VICH guidance document is intended to address the nature and types of data that can be useful in determining an ARfD for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. III. Significance of Guidance This draft guidance, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD). 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. IV. Paperwork Reduction Act of 1995 This draft 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 Action 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. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. VI. 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 http://www.regulations.gov. Dated: May 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-13105 Filed 5-29-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices 31041
Applicants must also demonstrate their DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
plans for engaging in shared decision HUMAN SERVICES Tong Zhou, Center for Veterinary
making activities with their Medicine (HFV–153), Food and Drug
beneficiaries. Applicants are required to Food and Drug Administration Administration, 7500 Standish Pl.,
submit to CMS general beneficiary data, Rockville, MD 20855, 240–402–0826,
[Docket No. FDA–2015–D–1804]
the clinical indicators needed to Tong.Zhou@fda.hhs.gov.
calculate the 10-year ASCVD risk score, International Cooperation on SUPPLEMENTARY INFORMATION:
and the cardiovascular Physician Harmonisation of Technical I. Background
Quality Reporting System (PQRS) Requirements for Registration of
Veterinary Medicinal Products; Studies FDA is announcing the availability of
measures as outlined in the RFA.
To Evaluate the Safety of Residues of a draft guidance for industry #232
Eligible practices will be selected on a entitled ‘‘Studies to Evaluate the Safety
first come, first served basis until all 720 Veterinary Drugs in Human Food:
General Approach To Establish an of Residues of Veterinary Drugs in
spots have been filled. Applications Human Food: General Approach to
must be submitted timely in the Acute Reference Dose; Draft Guidance
for Industry; Availability Establish an Acute Reference Dose
standard format outlined in the CVD (ARfD)’’ (VICH GL54). In recent years,
Risk Reduction Model RFA in order to AGENCY: Food and Drug Administration, many important initiatives have been
be considered for review. Applications HHS. undertaken by regulatory authorities
that are not received in this format will ACTION: Notice. and industry associations to promote
not be considered for review. the international harmonization of
For more specific details regarding the SUMMARY: The Food and Drug regulatory requirements. FDA has
CVD Risk Reduction Model (including Administration (FDA or Agency) is participated in efforts to enhance
the RFA), we refer applicants to the announcing the availability of a draft harmonization and has expressed its
informational materials on the guidance for industry (GFI) #232 commitment to seek scientifically based
entitled ‘‘Studies to Evaluate the Safety harmonized technical procedures for the
Innovation Center Web site at: http://
of Residues of Veterinary Drugs in development of pharmaceutical
innovation.cms.gov/initiatives/Million-
Human Food: General Approach to products. One of the goals of
Hearts-CVDRRM/. Applicants are harmonization is to identify, and then
Establish an Acute Reference Dose
responsible for monitoring the Web site reduce, differences in technical
(ARfD)’’ (VICH GL54). This draft
to obtain the most current information guidance has been developed for requirements for drug development
available. veterinary use by the International among regulatory agencies in different
III. Collection of Information Cooperation on Harmonisation of countries.
Technical Requirements for Registration FDA has actively participated in the
Requirements
of Veterinary Medicinal Products International Conference on
Section 1115A(d)(3) of the Social (VICH). This draft VICH guidance Harmonisation of Technical
Security Act states that chapter 35 of document is intended to address the Requirements for Registration of
title 44, United States Code (the nature and types of data that can be Pharmaceuticals for Human Use (ICH)
Paperwork Reduction Act of 1995), shall useful in determining an ARfD for for several years to develop harmonized
not apply to the testing and evaluation residues of veterinary drugs, the studies technical requirements for the approval
that may generate such data, and how of human pharmaceutical and biological
of models or expansion of the models
the ARfD may be calculated based on products among the European Union,
under this section. Consequently, there
these data. Japan, and the United States. The VICH
is no need for this document to be is a parallel initiative for veterinary
reviewed by the Office of Management DATES: Although you can comment on
medicinal products. The VICH is
and Budget under the authority of the any guidance at any time (see 21 CFR concerned with developing harmonized
Paperwork Reduction Act of 1995 (44 10.115(g)(5)), to ensure that the Agency technical requirements for the approval
U.S.C. 35). considers your comment on this draft of veterinary medicinal products in the
guidance before it begins work on the European Union, Japan, and the United
Dated: May 15, 2015.
final version of the guidance, submit States, and includes input from both
Andrew M. Slavitt, either electronic or written comments regulatory and industry representatives.
Acting Administrator, Centers for Medicare on the draft guidance by July 31, 2015. The VICH Steering Committee is
& Medicaid Services. ADDRESSES: Submit written requests for composed of member representatives
[FR Doc. 2015–13042 Filed 5–28–15; 11:15 am] single copies of the draft guidance to the from the European Commission;
BILLING CODE 4120–01–P Policy and Regulations Staff (HFV–6), European Medicines Evaluation Agency;
Center for Veterinary Medicine, Food European Federation of Animal Health;
and Drug Administration, 7519 Standish Committee on Veterinary Medicinal
Pl., Rockville, MD 20855. Send one self- Products; FDA; the U.S. Department of
addressed adhesive label to assist that Agriculture; the Animal Health
office in processing your request. See Institute; the Japanese Veterinary
the SUPPLEMENTARY INFORMATION section Pharmaceutical Association; the
for electronic access to the draft Japanese Association of Veterinary
guidance document. Biologics; and the Japanese Ministry of
Lhorne on DSK2VPTVN1PROD with NOTICES
Submit electronic comments on the Agriculture, Forestry, and Fisheries.
draft guidance to http:// Six observers are eligible to
www.regulations.gov. Submit written participate in the VICH Steering
comments to the Division of Dockets Committee: One representative from the
Management (HFA–305), Food and Drug government of Australia/New Zealand,
Administration, 5630 Fishers Lane, Rm. one representative from the industry in
1061, Rockville, MD 20852. Australia/New Zealand, one
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![31042 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
representative from the government of V. Comments in brackets in the heading of this
Canada, one representative from the Interested persons may submit either document.
industry of Canada, one representative electronic comments regarding this FOR FURTHER INFORMATION CONTACT: FDA
from the government of South Africa, document to http://www.regulations.gov PRA Staff, Office of Operations, Food
and one representative from the or written comments to the Division of and Drug Administration, 8455
industry of South Africa. The VICH Dockets Management (see ADDRESSES). It Colesville Rd., COLE–14526, Silver
Secretariat, which coordinates the is only necessary to send one set of Spring, MD 20993–0002, PRAStaff@
preparation of documentation, is comments. Identify comments with the fda.hhs.gov.
provided by the International docket number found in brackets in the SUPPLEMENTARY INFORMATION: In
Federation for Animal Health (IFAH). heading of this document. Received
An IFAH representative also compliance with 44 U.S.C. 3507, FDA
comments may be seen in the Division has submitted the following proposed
participates in the VICH Steering of Dockets Management between 9 a.m.
Committee meetings. collection of information to OMB for
and 4 p.m., Monday through Friday, and review and clearance.
II. Draft Guidance on Studies To will be posted to the docket at http://
www.regulations.gov. MedWatch: The FDA Medical Products
Evaluate the Safety of Residues of
Reporting Program OMB Control
Veterinary Drugs in Human Food: VI. Electronic Access Number 0910–0291—Extension
General Approach To Establish an
Acute Reference Dose (ARfD) Persons with access to the Internet I. Background
may obtain the draft guidance at either
The VICH Steering Committee held a http://www.fda.gov/AnimalVeterinary/ To ensure the marketing of safe and
meeting in February 2015 and agreed GuidanceComplianceEnforcement/ effective products, it is critical that
that the draft guidance document GuidanceforIndustry/default.htm or postmarketing adverse outcomes and
entitled ‘‘Studies to Evaluate the Safety http://www.regulations.gov. product problems are reported for all
of Residues of Veterinary Drugs in FDA-regulated human healthcare
Dated: May 27, 2015. products, including drugs (prescription
Human Food: General Approach to Leslie Kux,
Establish an Acute Reference Dose and nonprescription), biologics, medical
Associate Commissioner for Policy. devices, dietary supplements and other
(ARfD)’’ (VICH GL54) should be made
available for public comment. This draft [FR Doc. 2015–13105 Filed 5–29–15; 8:45 am] special nutritional products (e.g. infant
VICH guidance document is intended to BILLING CODE 4164–01–P formula and medical foods), and
address the nature and types of data that cosmetics. To facilitate reporting on
can be useful in determining an ARfD human medical products (except
DEPARTMENT OF HEALTH AND vaccines) during their postapproval and
for residues of veterinary drugs, the
HUMAN SERVICES marketed lifetimes, three forms
studies that may generate such data, and
(collectively known as the MedWatch
how the ARfD may be calculated based Food and Drug Administration forms) are available from the Agency.
on these data.
[Docket No. FDA–2014–N–1960] Form FDA 3500 is intended to be used
FDA and the VICH Expert Working for voluntary (i.e., not mandated by law
Group will consider comments about Agency Information Collection or regulation) reporting by healthcare
the draft guidance document. Activities; Submission for Office of professionals. Form FDA 3500B is
III. Significance of Guidance Management and Budget Review; written in plain language and is
Comment Request; MedWatch: The intended to be used for voluntary
This draft guidance, developed under Food and Drug Administration Medical reporting (i.e., not mandated by law or
the VICH process, has been revised to Products Reporting Program regulation) by consumers (i.e., patients
conform to FDA’s good guidance and their caregivers). Form FDA 3500A
practices regulation (21 CFR 10.115). AGENCY: Food and Drug Administration, is used for mandatory reporting (i.e.,
The draft guidance, when finalized, will HHS. required by law or regulation). When
represent the current thinking of FDA ACTION: Notice. FDA receives this information from
on Studies to Evaluate the Safety of healthcare professionals, patients, or
Residues of Veterinary Drugs in Human SUMMARY: The Food and Drug
Administration (FDA) is announcing consumers, the report becomes data that
Food: General Approach to Establish an will be used to assess and evaluate the
Acute Reference Dose (ARfD). It does that a proposed collection of
information has been submitted to the risk associated with the product. FDA
not establish any rights for any person will then take whatever action is
and is not binding on FDA or the public. Office of Management and Budget
(OMB) for review and clearance under necessary to reduce, mitigate, or
You can use an alternative approach if eliminate the public’s exposure to the
it satisfies the requirements of the the Paperwork Reduction Act of 1995.
risk through regulatory and public
applicable statutes and regulations. DATES: Fax written comments on the
health interventions.
collection of information by July 1,
IV. Paperwork Reduction Act of 1995 2015. Authorizing Statutes and Codified
This draft guidance refers to ADDRESSES: To ensure that comments on Regulations
previously approved collections of the information collection are received, The Federal Food, Drug, and Cosmetic
information found in FDA regulations. OMB recommends that written Act (the FD&C Act) (21 U.S.C. 353b,
These collections of information are comments be faxed to the Office of 355, 360i, 360l, and 393) and the Public
Lhorne on DSK2VPTVN1PROD with NOTICES
subject to review by the Office of Information and Regulatory Affairs, Health Service Act (42 U.S.C. 262)
Management and Budget (OMB) under OMB, Attn: FDA Desk Officer, FAX: represent the statutory authority for the
the Paperwork Reduction Action of 202–395–7285, or emailed to oira_ FDA to collect mandatory adverse event
1995 (44 U.S.C. 3501–3520). The submission@omb.eop.gov. All reports from regulated industry on
collections of information in 21 CFR comments should be identified with the medical products once approved for
part 514 have been approved under OMB control number 0910–0291. Also marketing to monitor the safety of drugs,
OMB control number 0910–0032. include the FDA docket number found biologics, medical devices, and dietary
VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1](https://thefederalregister.org/doc/80_FR_31145/page/2.svg)
Document Created: 2015-12-15 15:18:40
Document Modified: 2015-12-15 15:18:40
| 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. | |
| 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 July 31, 2015. | |
| Contact | Tong Zhou, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0826, [email protected] | |
| FR Citation | 80 FR 31041 |
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