Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R); Request for Comments; Availability, 50771-50772 [2010-20235]

Download as PDF Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices Dated: August 10, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. 2010–20302 Filed 8–16–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings jdjones on DSK8KYBLC1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Nanotechnology Administrative Centers Contract Review. Date: August 20, 2010. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call) Contact Person: Shelley S Sehnert, PhD, Scientific Review Officer, Review Branch/ DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7206, Bethesda, MD 20892–7924, 301–435–0303, ssehnert@nhlbi.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; HLBI Proteomics Administrative Centers Contract Review. Date: August 20, 2010. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call) Contact Person: Shelley S Sehnert, PhD, Scientific Review Officer, Review Branch/ DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7206, Bethesda, MD 20892–7924, 301–435–0303, ssehnert@nhlbi.nih.gov. VerDate Mar<15>2010 15:16 Aug 16, 2010 Jkt 220001 This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Ancillary Studies in Clinical Trials. Date: August 25, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Chang Sook Kim, PhD, Scientific Review Officer, Review Branch, DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7190, Bethesda, MD 20892, 301–435–0287, carolko@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: August 4, 2010. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–20291 Filed 8–16–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Diabetes and Obesity. Date: August 24, 2010. Time: 10 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Michael Knecht, PhD, Scientific Review Officer, Center for Fmt 4703 Sfmt 4703 Dated: August 10, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–20287 Filed 8–16–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1999–D–2955] (formerly Docket No. 1999D–4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R); Request for Comments; Availability AGENCY: ACTION: Center for Scientific Review; Notice of Closed Meeting Frm 00029 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6176, MSC 7892, Bethesda, MD 20892, (301) 435– 1046, knechtm@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Food and Drug Administration, HHS. National Institutes of Health PO 00000 50771 Notice. The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (#100) entitled ‘‘Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R).’’ This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the Federal Register of May 22, 2001 (66 FR 28182) (the 2001 final guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The guidance is intended to recommend acceptable amounts of residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the target animal as well as for the safety of human consumers of products derived from treated food producing animals. It is intended to assist in developing new animal drug applications (referred to as marketing applications in this guidance) submitted SUMMARY: E:\FR\FM\17AUN1.SGM 17AUN1 50772 Federal Register / Vol. 75, No. 158 / Tuesday, August 17, 2010 / Notices jdjones on DSK8KYBLC1PROD with NOTICES to the European Union, Japan, and the United States. 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 October 18, 2010. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 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. Submit electronic comments on the draft guidance to https:// 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: Mai Huynh, Center for Veterinary Medicine (HFV–142), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8273, mai.huynh@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background 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 Harmonization of Technical Requirements for Approval of Pharmaceuticals for Human Use 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 VerDate Mar<15>2010 15:16 Aug 16, 2010 Jkt 220001 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, the U.S. Food and Drug Administration, 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. Four 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, and one representative from the industry of Canada. 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 Revised Guidance on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients In April 2010, the VICH Steering Committee agreed that a draft revised guidance entitled ‘‘Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R)’’ should be made available for public comment. The draft revised guidance is a revision of the 2001 final guidance on the same topic. The draft revised guidance revises the lower PDE (permissible daily exposure) for N–Methylpyrrolidone being kept in Class 2 (Table 2 of the draft revised guidance) and for Tetrahydrofuran being placed into Class 2 from Class 3 (Table 3 of the draft revised guidance). The draft revised guidance is a product of the Quality Expert Working Group of the VICH. Comments about this draft will be considered by FDA and the VICH Quality Expert Working Group. III. Paperwork Reduction Act of 1995 This draft revised guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in sections II–VI of this document have been approved under OMB Control No. 0910–0032. IV. Significance of Guidance This draft guidance developed under the VICH process, includes mandatory language that does not describe a statutory or regulatory requirement, as permitted by good guidance practices regulation (21 CFR 10.115(i)(3)). Mandatory language that does not describe a statutory or regulatory requirement will be revised in the final guidance document. The draft revised VICH guidance (GFI #100) is consistent with the agency’s current thinking on this topic. This guidance does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative method may be used as long as it satisfies the requirements of applicable statutes and regulations. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. VI. 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: August 9, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–20235 Filed 8–16–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Agency Information Collection Activities: Importation Bond Structure U.S. Customs and Border Protection, Department of Homeland Security. AGENCY: E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Notices]
[Pages 50771-50772]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20235]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-2955] (formerly Docket No. 1999D-4071)


Draft Revised Guidance for Industry on Residual Solvents in New 
Veterinary Medicinal Products, Active Substances and Excipients 
(Revision) VICH GL18(R); Request for Comments; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability for comments of a draft revised guidance for industry 
(100) entitled ``Residual Solvents in New Veterinary Medicinal 
Products, Active Substances and Excipients (Revision) VICH GL18(R).'' 
This draft revised guidance, which updates a final guidance on the same 
topic for which a notice of availability was published in the Federal 
Register of May 22, 2001 (66 FR 28182) (the 2001 final guidance), has 
been developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). The guidance is intended to recommend 
acceptable amounts of residual solvents in new animal drugs (referred 
to as pharmaceuticals or veterinary medicinal products in this 
guidance) for the safety of the target animal as well as for the safety 
of human consumers of products derived from treated food producing 
animals. It is intended to assist in developing new animal drug 
applications (referred to as marketing applications in this guidance) 
submitted

[[Page 50772]]

to the European Union, Japan, and the United States.

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 October 18, 2010.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Communications Staff (HFV-12), 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 requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to https://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:  Mai Huynh, Center for Veterinary 
Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8273, mai.huynh@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    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 
Harmonization of Technical Requirements for Approval of Pharmaceuticals 
for Human Use 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, the U.S. Food and Drug Administration, 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.
    Four 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, and one 
representative from the industry of Canada. 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 Revised Guidance on Residual Solvents in New Veterinary 
Medicinal Products, Active Substances and Excipients

    In April 2010, the VICH Steering Committee agreed that a draft 
revised guidance entitled ``Residual Solvents in New Veterinary 
Medicinal Products, Active Substances and Excipients (Revision) VICH 
GL18(R)'' should be made available for public comment. The draft 
revised guidance is a revision of the 2001 final guidance on the same 
topic. The draft revised guidance revises the lower PDE (permissible 
daily exposure) for N-Methylpyrrolidone being kept in Class 2 (Table 2 
of the draft revised guidance) and for Tetrahydrofuran being placed 
into Class 2 from Class 3 (Table 3 of the draft revised guidance). The 
draft revised guidance is a product of the Quality Expert Working Group 
of the VICH. Comments about this draft will be considered by FDA and 
the VICH Quality Expert Working Group.

III. Paperwork Reduction Act of 1995

    This draft revised 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 sections II-VI of this 
document have been approved under OMB Control No. 0910-0032.

IV. Significance of Guidance

    This draft guidance developed under the VICH process, includes 
mandatory language that does not describe a statutory or regulatory 
requirement, as permitted by good guidance practices regulation (21 CFR 
10.115(i)(3)). Mandatory language that does not describe a statutory or 
regulatory requirement will be revised in the final guidance document.
    The draft revised VICH guidance (GFI 100) is consistent 
with the agency's current thinking on this topic. This guidance does 
not create or confer any rights for or on any person and will not 
operate to bind FDA or the public. An alternative method may be used as 
long as it satisfies the requirements of applicable statutes and 
regulations.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

VI. 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: August 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20235 Filed 8-16-10; 8:45 am]
BILLING CODE 4160-01-S
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