83 FR 35009 - 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in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 142 (July 24, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 142 (July 24, 2018)
| Page Range | 35009-35011 | |
| FR Document | 2018-15778 |
[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)] [Notices] [Pages 35009-35011] From the Federal Register Online [www.thefederalregister.org] [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in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #257 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue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 This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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 This VICH draft guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill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 This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species. DATES: Submit either electronic or written comments on the draft guidance by September 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.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 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 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
![Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35009
Drug Uses reviewed
Quercetin ............................................ Asthma, allergy, cancer prevention and treatment, and hypertension.
FDA intends to make background at least 7 days in advance of the residue depletion data to fulfill the
material available to the public no later meeting. national/regional requirements. This
than 2 business days before the meeting. FDA is committed to the orderly draft guidance document provides
If FDA is unable to post the background conduct of its advisory committee recommendations on what should be
material on its website prior to the meetings. Please visit our website at included in a marker residue depletion
meeting, the background material will https://www.fda.gov/ study design for aquatic food-producing
be made publicly available at the AdvisoryCommittees/ species.
location of the advisory committee AboutAdvisoryCommittees/ DATES: Submit either electronic or
meeting, and the background material ucm111462.htm for procedures on written comments on the draft guidance
will be posted on FDA’s website after public conduct during advisory by September 24, 2018 to ensure that
the meeting. Background material is committee meetings. the Agency considers your comment on
available at https://www.fda.gov/ Notice of this meeting is given under this draft guidance before it begins work
AdvisoryCommittees/Calendar/ the Federal Advisory Committee Act (5 on the final version of the guidance.
default.htm. Scroll down to the U.S.C. app. 2). ADDRESSES: You may submit comments
appropriate advisory committee meeting Dated: July 19, 2018. on any guidance at any time as follows:
link. Leslie Kux,
Procedure: Interested persons may Electronic Submissions
Associate Commissioner for Policy.
present data, information, or views, Submit electronic comments in the
[FR Doc. 2018–15782 Filed 7–23–18; 8:45 am]
orally or in writing, on issues pending following way:
BILLING CODE 4164–01–P
before the committee. All electronic and • Federal eRulemaking Portal:
written submissions submitted to the https://www.regulations.gov. Follow the
Docket (see ADDRESSES) on or before instructions for submitting comments.
DEPARTMENT OF HEALTH AND
August 28, 2018, will be provided to the Comments submitted electronically,
HUMAN SERVICES
committee. Oral presentations from the including attachments, to https://
public will be scheduled between Food and Drug Administration www.regulations.gov will be posted to
approximately 9:30 a.m. and 9:40 a.m., the docket unchanged. Because your
10:45 a.m. and 10:55 a.m., 11:50 a.m. [Docket No. FDA–2018–D–2354]
comment will be made public, you are
and 12 noon, 1:50 p.m. and 2 p.m., 3:05 solely responsible for ensuring that your
International Cooperation on
p.m. and 3:15 p.m., and 4:10 p.m. and comment does not include any
Harmonisation of Technical
4:20 p.m. Those individuals interested confidential information that you or a
Requirements for Registration of
in making formal oral presentations third party may not wish to be posted,
Veterinary Medicinal Products; Studies
should notify the contact person and such as medical information, your or
To Evaluate the Metabolism and
submit a brief statement of the general anyone else’s Social Security number, or
Residue Kinetics of Veterinary Drugs
nature of the evidence or arguments confidential business information, such
in Food-Producing Species: Marker
they wish to present, the names and as a manufacturing process. Please note
Residue Depletion Studies To
addresses of proposed participants, and that if you include your name, contact
Establish Product Withdrawal Periods
an indication of the approximate time information, or other information that
in Aquatic Species; Draft Guidance for
requested to make their presentation on identifies you in the body of your
Industry; Availability
or before August 20, 2018. Time allotted comments, that information will be
for each presentation may be limited. If AGENCY: Food and Drug Administration, posted on https://www.regulations.gov.
the number of registrants requesting to HHS. • If you want to submit a comment
speak is greater than can be reasonably ACTION: Notice of availability. with confidential information that you
accommodated during the scheduled do not wish to be made available to the
open public hearing session, FDA may SUMMARY: The Food and Drug public, submit the comment as a
conduct a lottery to determine the Administration (FDA or Agency) is written/paper submission and in the
speakers for the scheduled open public announcing the availability of a draft manner detailed (see ‘‘Written/Paper
hearing session. The contact person will guidance for industry (GFI) #257 Submissions’’ and ‘‘Instructions’’).
notify interested persons regarding their entitled ‘‘Studies to Evaluate the
request to speak by August 21, 2018. Metabolism and Residue Kinetics of Written/Paper Submissions
Persons attending FDA’s advisory Veterinary Drugs in Food-Producing Submit written/paper submissions as
committee meetings are advised that Species: Marker Residue Depletion follows:
FDA is not responsible for providing Studies to Establish Product Withdrawal • Mail/Hand Delivery/Courier (for
access to electrical outlets. Periods in Aquatic Species’’ (VICH written/paper submissions): Dockets
For press inquiries, please contact the GL57). This draft guidance has been Management Staff (HFA–305), Food and
Office of Media Affairs at fdaoma@ developed for veterinary use by the Drug Administration, 5630 Fishers
fda.hhs.gov or 301–796–4540. International Cooperation on
jstallworth on DSKBBY8HB2PROD with NOTICES
Lane, Rm. 1061, Rockville, MD 20852.
FDA welcomes the attendance of the Harmonisation of Technical • For written/paper comments
public at its advisory committee Requirements for Registration of submitted to the Dockets Management
meetings and will make every effort to Veterinary Medicinal Products (VICH). Staff, FDA will post your comment, as
accommodate persons with disabilities. This VICH draft guidance document is well as any attachments, except for
If you require accommodations due to a intended to provide study design information submitted, marked and
disability, please contact Jay Fajiculay recommendations that will facilitate the identified, as confidential, if submitted
(see FOR FURTHER INFORMATION CONTACT) universal acceptance of the generated as detailed in ‘‘Instructions.’’
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![Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35011
IV. Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION: The 2. Any allegation in a petition that the
This draft guidance refers to Program provides a system of no-fault petitioner either:
previously approved collections of compensation for certain individuals a. ‘‘[S]ustained, or had significantly
information found in FDA regulations. who have been injured by specified aggravated, any illness, disability,
These collections of information are childhood vaccines. Subtitle 2 of Title injury, or condition not set forth in the
subject to review by the Office of XXI of the PHS Act, 42 U.S.C. 300aa– Vaccine Injury Table but which was
Management and Budget (OMB) under 10 et seq., provides that those seeking caused by’’ one of the vaccines referred
the Paperwork Reduction Act of 1995 compensation are to file a petition with to in the Table, or
(44 U.S.C. 3501–3520). The collections the U.S. Court of Federal Claims and to b. ‘‘[S]ustained, or had significantly
of information in 21 CFR part 514 have serve a copy of the petition on the aggravated, any illness, disability,
been approved under OMB control Secretary of HHS, who is named as the injury, or condition set forth in the
number 0910–0032. respondent in each proceeding. The Vaccine Injury Table the first symptom
Secretary has delegated this or manifestation of the onset or
V. Electronic Access responsibility under the Program to significant aggravation of which did not
Persons with access to the internet HRSA. The Court is directed by statute occur within the time period set forth in
may obtain the draft guidance at either to appoint special masters who take the Table but which was caused by a
https://www.fda.gov/AnimalVeterinary/ evidence, conduct hearings as vaccine’’ referred to in the Table.
GuidanceComplianceEnforcement/ appropriate, and make initial decisions In accordance with Section
GuidanceforIndustry/default.htm or as to eligibility for, and amount of, 2112(b)(2), all interested persons may
https://www.regulations.gov. compensation. submit written information relevant to
Dated: July 17, 2018. A petition may be filed with respect the issues described above in the case of
Leslie Kux, to injuries, disabilities, illnesses, the petitions listed below. Any person
Associate Commissioner for Policy. conditions, and deaths resulting from choosing to do so should file an original
vaccines described in the Vaccine Injury and three (3) copies of the information
[FR Doc. 2018–15778 Filed 7–23–18; 8:45 am]
Table (the Table) set forth at 42 CFR with the Clerk of the U.S. Court of
BILLING CODE 4164–01–P
100.3. This Table lists for each covered Federal Claims at the address listed
childhood vaccine the conditions that above (under the heading FOR FURTHER
may lead to compensation and, for each INFORMATION CONTACT), with a copy to
DEPARTMENT OF HEALTH AND
HUMAN SERVICES condition, the time period for HRSA addressed to Director, Division of
occurrence of the first symptom or Injury Compensation Programs,
Health Resources and Services manifestation of onset or of significant Healthcare Systems Bureau, 5600
Administration aggravation after vaccine Fishers Lane, 08N146B, Rockville, MD
administration. Compensation may also 20857. The Court’s caption (Petitioner’s
National Vaccine Injury Compensation be awarded for conditions not listed in Name v. Secretary of Health and Human
Program; List of Petitions Received the Table and for conditions that are Services) and the docket number
manifested outside the time periods assigned to the petition should be used
AGENCY: Health Resources and Services
Administration (HRSA), Department of specified in the Table, but only if the as the caption for the written
Health and Human Services (HHS). petitioner shows that the condition was submission. Chapter 35 of title 44,
caused by one of the listed vaccines. United States Code, related to
ACTION: Notice.
Section 2112(b)(2) of the PHS Act, 42 paperwork reduction, does not apply to
SUMMARY: HRSA is publishing this U.S.C. 300aa–12(b)(2), requires that information required for purposes of
notice of petitions received under the ‘‘[w]ithin 30 days after the Secretary carrying out the Program.
National Vaccine Injury Compensation receives service of any petition filed Dated: July 18, 2018.
Program (the Program), as required by under section 2111 the Secretary shall George Sigounas,
the Public Health Service (PHS) Act, as publish notice of such petition in the Administrator.
amended. While the Secretary of HHS is Federal Register.’’ Set forth below is a
named as the respondent in all list of petitions received by HRSA on List of Petitions Filed
proceedings brought by the filing of June 1, 2018, through June 30, 2018. 1. Ronald Discher, Gales Ferry, Connecticut,
petitions for compensation under the This list provides the name of Court of Federal Claims No: 18–0777V
Program, the United States Court of petitioner, city and state of vaccination 2. Thomas Becktold, Soddy Daisy,
Federal Claims is charged by statute (if unknown then city and state of Tennessee, Court of Federal Claims No:
with responsibility for considering and person or attorney filing claim), and 18–0782V
acting upon the petitions. case number. In cases where the Court 3. Fay Bleier, Salamanca, New York, Court of
has redacted the name of a petitioner Federal Claims No: 18–0783V
FOR FURTHER INFORMATION CONTACT: For
and/or the case number, the list reflects 4. Adriane Davis and Sylvester Davis on
information about requirements for behalf of E.D., Springfield, Missouri,
filing petitions, and the Program in such redaction. Court of Federal Claims No: 18–0784V
general, contact Lisa L. Reyes, Clerk of Section 2112(b)(2) also provides that 5. Marie Brow. Stanley, North Carolina, Court
Court, United States Court of Federal the special master ‘‘shall afford all of Federal Claims No: 18–0786V
Claims, 717 Madison Place NW, interested persons an opportunity to 6. Karen Knepp, Pittsburgh, Pennsylvania,
Washington, DC 20005, (202) 357–6400. submit relevant, written information’’ Court of Federal Claims No: 18–0790V
For information on HRSA’s role in the relating to the following: 7. Andrew Trujillo, Las Cruces, New Mexico,
jstallworth on DSKBBY8HB2PROD with NOTICES
Program, contact the Director, National 1. The existence of evidence ‘‘that Court of Federal Claims No: 18–0791V
Vaccine Injury Compensation Program, there is not a preponderance of the 8. Jennifer Jackson, Columbia, South
Carolina, Court of Federal Claims No:
5600 Fishers Lane, Room 08N146B, evidence that the illness, disability, 18–0793V
Rockville, MD 20857; (301) 443–6593, injury, condition, or death described in 9. Lynann Raymer on behalf of J.R., Phoenix,
or visit our website at: http:// the petition is due to factors unrelated Arizona, Court of Federal Claims No: 18–
www.hrsa.gov/vaccinecompensation/ to the administration of the vaccine 0794V
index.html. described in the petition,’’ and 10. Molly Anderson, Washington, District of
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Document Created: 2018-07-24 00:10:33
Document Modified: 2018-07-24 00:10:33
| 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 | 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. | |
| 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 35009 |
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