International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Draft Guidance for Industry; Availability, 35009-35011 [2018-15778]

Download as PDF Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices Drug Uses reviewed jstallworth on DSKBBY8HB2PROD with NOTICES Quercetin ............................................ Asthma, allergy, cancer prevention and treatment, and hypertension. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before August 28, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 9:40 a.m., 10:45 a.m. and 10:55 a.m., 11:50 a.m. and 12 noon, 1:50 p.m. and 2 p.m., 3:05 p.m. and 3:15 p.m., and 4:10 p.m. and 4:20 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 20, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 21, 2018. Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) VerDate Sep<11>2014 13:59 Jul 23, 2018 35009 Jkt 244001 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–15782 Filed 7–23–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2354] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #257 entitled ‘‘Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species’’ (VICH GL57). 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 VICH draft guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 residue depletion data to fulfill the national/regional requirements. This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species. DATES: Submit either electronic or written comments on the draft guidance by September 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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.’’ E:\FR\FM\24JYN1.SGM 24JYN1 jstallworth on DSKBBY8HB2PROD with NOTICES 35010 Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices Instructions: All submissions received must include the Docket No. FDA– 2018–D–2354 for ‘‘Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic 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 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 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 VerDate Sep<11>2014 13:59 Jul 23, 2018 Jkt 244001 Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary Medicine (HFV–151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0788, Julia.oriani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft GFI #257 entitled ‘‘Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in FoodProducing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species’’ (VICH GL57). 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 Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 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 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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 VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health. II. Draft Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species The VICH Steering Committee held a meeting in November 2017 and agreed that the draft guidance document entitled ‘‘Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species’’ (VICH GL 57) should be made available for public comment. This draft 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. This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. III. Significance of Guidance This level 1 draft 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 do 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 draft guidance, when finalized, will represent 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. E:\FR\FM\24JYN1.SGM 24JYN1 Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 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 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. V. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: July 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–15778 Filed 7–23–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443–6593, or visit our website at: https:// www.hrsa.gov/vaccinecompensation/ index.html. jstallworth on DSKBBY8HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 13:59 Jul 23, 2018 Jkt 244001 The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa–12(b)(2), requires that ‘‘[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.’’ Set forth below is a list of petitions received by HRSA on June 1, 2018, through June 30, 2018. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction. Section 2112(b)(2) also provides that the special master ‘‘shall afford all interested persons an opportunity to submit relevant, written information’’ relating to the following: 1. The existence of evidence ‘‘that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,’’ and SUPPLEMENTARY INFORMATION: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 35011 2. Any allegation in a petition that the petitioner either: a. ‘‘[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by’’ one of the vaccines referred to in the Table, or b. ‘‘[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine’’ referred to in the Table. In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading FOR FURTHER INFORMATION CONTACT), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, MD 20857. The Court’s caption (Petitioner’s Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program. Dated: July 18, 2018. George Sigounas, Administrator. List of Petitions Filed 1. Ronald Discher, Gales Ferry, Connecticut, Court of Federal Claims No: 18–0777V 2. Thomas Becktold, Soddy Daisy, Tennessee, Court of Federal Claims No: 18–0782V 3. Fay Bleier, Salamanca, New York, Court of Federal Claims No: 18–0783V 4. Adriane Davis and Sylvester Davis on behalf of E.D., Springfield, Missouri, Court of Federal Claims No: 18–0784V 5. Marie Brow. Stanley, North Carolina, Court of Federal Claims No: 18–0786V 6. Karen Knepp, Pittsburgh, Pennsylvania, Court of Federal Claims No: 18–0790V 7. Andrew Trujillo, Las Cruces, New Mexico, Court of Federal Claims No: 18–0791V 8. Jennifer Jackson, Columbia, South Carolina, Court of Federal Claims No: 18–0793V 9. Lynann Raymer on behalf of J.R., Phoenix, Arizona, Court of Federal Claims No: 18– 0794V 10. Molly Anderson, Washington, District of E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Notices]
[Pages 35009-35011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15778]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2354]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Studies 
To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in 
Food-Producing Species: Marker Residue Depletion Studies To Establish 
Product Withdrawal Periods in Aquatic Species; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry (GFI) #257 entitled 
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 
Drugs in Food-Producing Species: Marker Residue Depletion Studies to 
Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57). 
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 VICH 
draft 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. This draft guidance document provides recommendations on 
what should be included in a marker residue depletion study design for 
aquatic food-producing species.

DATES: Submit either electronic or written comments on the draft 
guidance by September 24, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.''

[[Page 35010]]

    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-2354 for ``Studies to Evaluate the Metabolism and Residue 
Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue 
Depletion Studies to Establish Product Withdrawal Periods in Aquatic 
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 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 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.gpo.gov/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 draft 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 a draft GFI #257 entitled 
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 
Drugs in Food-Producing Species: Marker Residue Depletion Studies to 
Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57). 
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 Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 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 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 VICH Secretariat, 
which coordinates the preparation of documentation, is provided by the 
International Federation for Animal Health.

II. Draft Guidance for Industry on Studies To Evaluate the Metabolism 
and Residue Kinetics of Veterinary Drugs in Food-Producing Species: 
Marker Residue Depletion Studies To Establish Product Withdrawal 
Periods in Aquatic Species

    The VICH Steering Committee held a meeting in November 2017 and 
agreed that the draft guidance document entitled ``Studies to Evaluate 
the Metabolism and Residue Kinetics of Veterinary Drugs in Food-
Producing Species: Marker Residue Depletion Studies to Establish 
Product Withdrawal Periods in Aquatic Species'' (VICH GL 57) should be 
made available for public comment. This draft 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. This draft guidance 
document provides recommendations on what should be included in a 
marker residue depletion study design for aquatic food-producing 
species.
    FDA and the VICH Expert Working Group will consider comments about 
the draft guidance document.

III. Significance of Guidance

    This level 1 draft 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 
do 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 draft guidance, when finalized, will represent 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.

[[Page 35011]]

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 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.

V. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: July 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15778 Filed 7-23-18; 8:45 am]
BILLING CODE 4164-01-P
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