81 FR 91179 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bioequivalence: Blood Level Bioequivalence Study; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 242 (December 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 242 (December 16, 2016)
| Page Range | 91179-91180 | |
| FR Document | 2016-30309 |
[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)] [Notices] [Pages 91179-91180] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30309] [[Page 91179]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1352] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bioequivalence: Blood Level Bioequivalence Study; 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 guidance for industry (GFI) #224 entitled ``Bioequivalence: Blood Level Bioequivalence Study'' (VICH GL52). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-D-1352 for ``Bioequivalence: Blood Level Bioequivalence Study.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, 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 guidance document. FOR FURTHER INFORMATION CONTACT: Marilyn Martinez, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0635, email: [email protected]. 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 Council for Harmonisation of Technical Requirements for 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 and [[Page 91180]] 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 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). II. Guidance on Bioequivalence: Blood Level Bioequivalence Study In the Federal Register of September 24, 2014 (79 FR 57113), FDA published the notice of availability for a draft guidance for industry entitled ``Bioequivalence: Blood Level Bioequivalence Study'' (VICH GL52) giving interested persons until November 24, 2014, to comment on the draft guidance. FDA received one comment on the draft guidance, and that comment, as well as those received by other VICH member regulatory agencies, was considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated September 2014. The final guidance is a product of the Bioequivalence Expert Working Group of the VICH. This VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products. To meet this objective, the guidance addresses the following topics: A harmonized definition of BE, factors/variables that should be considered when developing scientifically sound blood level BE study designs, and information that should be included in a blood level BE study report. III. Significance of Guidance This guidance, developed under the VICH process, is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated ``guidance'' rather than ``guideline.'' In addition, guidance documents must not include mandatory language such as ``shall,'' ``must,'' ``require,'' or ``requirement,'' unless FDA is using these words to describe a statutory or regulatory requirement. This guidance represents the current thinking of FDA on ``Bioequivalence: Blood Level Bioequivalence Study.'' 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 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. The collections of information in section 512(n)(1) of the FD&C Act (21 U.S.C. 360K) have been approved under OMB control number 0910-0669. V. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: December 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-30309 Filed 12-15-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices 91179
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
Food and Drug Administration Written/Paper Submissions
received, go to https://
[Docket No. FDA–2014–D–1352] Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
International Cooperation on • Mail/Hand delivery/Courier (for heading of this document, into the
Harmonisation of Technical written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Requirements for Registration of Dockets Management (HFA–305), Food and/or go to the Division of Dockets
Veterinary Medicinal Products; and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Bioequivalence: Blood Level Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
Bioequivalence Study; Guidance for • For written/paper comments Submit written requests for single
Industry; Availability submitted to the Division of Dockets copies of the guidance to the Policy and
Management, FDA will post your Regulations Staff (HFV–6), Center for
AGENCY: Food and Drug Administration, Veterinary Medicine, Food and Drug
comment, as well as any attachments,
HHS. Administration, 7519 Standish Pl.,
except for information submitted,
ACTION: Notice. marked and identified, as confidential, Rockville, MD 20855. Send one self-
SUMMARY: The Food and Drug if submitted as detailed in addressed adhesive label to assist that
Administration (FDA or Agency) is ‘‘Instructions.’’ office in processing your requests. See
announcing the availability of guidance Instructions: All submissions received the SUPPLEMENTARY INFORMATION section
for industry (GFI) #224 entitled must include the Docket No. FDA– for electronic access to the guidance
‘‘Bioequivalence: Blood Level 2014–D–1352 for ‘‘Bioequivalence: document.
Bioequivalence Study’’ (VICH GL52). Blood Level Bioequivalence Study.’’ FOR FURTHER INFORMATION CONTACT:
This guidance has been developed for Received comments will be placed in Marilyn Martinez, Center for Veterinary
veterinary use by the International the docket and, except for those Medicine (HFV–100), Food and Drug
Cooperation on Harmonisation of submitted as ‘‘Confidential Administration, 7500 Standish Pl.,
Technical Requirements for Registration Submissions,’’ publicly viewable at Rockville, MD 20855, 240–402–0635,
of Veterinary Medicinal Products https://www.regulations.gov or at the email: Marilyn.Martinez@fda.hhs.gov.
(VICH). This VICH guidance document Division of Dockets Management SUPPLEMENTARY INFORMATION:
is intended to harmonize the data between 9 a.m. and 4 p.m., Monday
recommendations associated with in through Friday. I. Background
vivo blood level bioequivalence (BE) for • Confidential Submissions—To In recent years, many important
veterinary pharmaceutical products. submit a comment with confidential initiatives have been undertaken by
DATES: Submit either electronic or information that you do not wish to be regulatory authorities and industry
written comments on Agency guidances made publicly available, submit your associations to promote the
at any time. comments only as a written/paper international harmonization of
ADDRESSES: You may submit comments submission. You should submit two regulatory requirements. FDA has
as follows: copies total. One copy will include the participated in efforts to enhance
information you claim to be confidential harmonization and has expressed its
Electronic Submissions with a heading or cover note that states commitment to seek scientifically based,
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS harmonized technical procedures for the
following way: CONFIDENTIAL INFORMATION.’’ The development of pharmaceutical
• Federal eRulemaking Portal: Agency will review this copy, including products. One of the goals of
https://www.regulations.gov. Follow the the claimed confidential information, in harmonization is to identify, and then
instructions for submitting comments. its consideration of comments. The reduce, differences in technical
Comments submitted electronically, second copy, which will have the requirements for drug development
including attachments, to https:// claimed confidential information among regulatory agencies in different
www.regulations.gov will be posted to redacted/blacked out, will be available countries.
the docket unchanged. Because your for public viewing and posted on FDA has actively participated in the
comment will be made public, you are https://www.regulations.gov. Submit International Council for Harmonisation
solely responsible for ensuring that your both copies to the Division of Dockets of Technical Requirements for
comment does not include any Management. If you do not wish your Pharmaceuticals for Human Use (ICH)
confidential information that you or a name and contact information to be for several years to develop harmonized
third party may not wish to be posted, made publicly available, you can technical requirements for the approval
such as medical information, your or provide this information on the cover of human pharmaceutical and biological
anyone else’s Social Security number, or sheet and not in the body of your products among the European Union,
confidential business information, such comments and you must identify this Japan, and the United States. The VICH
as a manufacturing process. Please note information as ‘‘confidential.’’ Any is a parallel initiative for veterinary
that if you include your name, contact information marked as ‘‘confidential’’ medicinal products. The VICH is
information, or other information that will not be disclosed except in concerned with developing harmonized
identifies you in the body of your accordance with 21 CFR 10.20 and other technical requirements for the approval
mstockstill on DSK3G9T082PROD with NOTICES
comments, that information will be applicable disclosure law. For more of veterinary medicinal products in the
posted on https://www.regulations.gov. information about FDA’s posting of European Union, Japan, and the United
• If you want to submit a comment comments to public dockets, see 80 FR States, and includes input from both
with confidential information that you 56469, September 18, 2015, or access regulatory and industry representatives.
do not wish to be made available to the the information at: http://www.fda.gov/ The VICH Steering Committee is
public, submit the comment as a regulatoryinformation/dockets/ composed of member representatives
written/paper submission and in the default.htm. from the European Commission and
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![91180 Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
European Medicines Agency; language such as ‘‘shall,’’ ‘‘must,’’ United States. The Secretary has
International Federation for Animal ‘‘require,’’ or ‘‘requirement,’’ unless delegated this gift authority to the
Health—Europe; FDA; the U.S. FDA is using these words to describe a Commissioner of Food and Drugs. This
Department of Agriculture; the U.S. statutory or regulatory requirement. guidance provides the process and
Animal Health Institute; the Japanese This guidance represents the current principles we will use in implementing
Ministry of Agriculture, Forestry, and thinking of FDA on ‘‘Bioequivalence: this authority.
Fisheries; and the Japanese Veterinary Blood Level Bioequivalence Study.’’ It DATES: Submit either electronic or
Products Association. does not establish any rights for any written comments on Agency guidances
Six observers are eligible to person and is not binding on FDA or the at any time.
participate in the VICH Steering public. You can use an alternative
ADDRESSES: You may submit comments
Committee: One representative from the approach if it satisfies the requirements
government of Australia/New Zealand, as follows:
of the applicable statutes and
one representative from the industry in regulations. Electronic Submissions
Australia/New Zealand, one
IV. Paperwork Reduction Act of 1995 Submit electronic comments in the
representative from the government of
This guidance refers to previously following way:
Canada, one representative from the
approved collections of information • Federal eRulemaking Portal:
industry of Canada, one representative
found in FDA regulations. These https://www.regulations.gov. Follow the
from the government of South Africa,
and one representative from the collections of information are subject to instructions for submitting comments.
industry of South Africa. The VICH review by the Office of Management and Comments submitted electronically,
Secretariat, which coordinates the Budget (OMB) under the Paperwork including attachments, to https://
preparation of documentation, is Reduction Act of 1995 (44 U.S.C. 3501– www.regulations.gov will be posted to
provided by the International 3520). The collections of information in the docket unchanged. Because your
Federation for Animal Health (IFAH). 21 CFR part 514 have been approved comment will be made public, you are
under OMB control number 0910–0032. solely responsible for ensuring that your
II. Guidance on Bioequivalence: Blood comment does not include any
The collections of information in
Level Bioequivalence Study confidential information that you or a
section 512(n)(1) of the FD&C Act (21
In the Federal Register of September U.S.C. 360K) have been approved under third party may not wish to be posted,
24, 2014 (79 FR 57113), FDA published OMB control number 0910–0669. such as medical information, your or
the notice of availability for a draft anyone else’s Social Security number, or
guidance for industry entitled V. Electronic Access confidential business information, such
‘‘Bioequivalence: Blood Level Persons with access to the Internet as a manufacturing process. Please note
Bioequivalence Study’’ (VICH GL52) may obtain the guidance at either http:// that if you include your name, contact
giving interested persons until www.fda.gov/AnimalVeterinary/ information, or other information that
November 24, 2014, to comment on the GuidanceComplianceEnforcement/ identifies you in the body of your
draft guidance. FDA received one GuidanceforIndustry/default.htm or comments, that information will be
comment on the draft guidance, and that http://www.regulations.gov. posted on https://www.regulations.gov.
comment, as well as those received by • If you want to submit a comment
Dated: December 12, 2016.
other VICH member regulatory agencies, with confidential information that you
Leslie Kux,
was considered as the guidance was do not wish to be made available to the
Associate Commissioner for Policy. public, submit the comment as a
finalized. The guidance announced in
[FR Doc. 2016–30309 Filed 12–15–16; 8:45 am] written/paper submission and in the
this notice finalizes the draft guidance
dated September 2014. The final BILLING CODE 4164–01–P manner detailed (see ‘‘Written/Paper
guidance is a product of the Submissions’’ and ‘‘Instructions’’).
Bioequivalence Expert Working Group Written/Paper Submissions
DEPARTMENT OF HEALTH AND
of the VICH.
HUMAN SERVICES Submit written/paper submissions as
This VICH guidance document is
intended to harmonize the data follows:
Food and Drug Administration
recommendations associated with in • Mail/Hand delivery/Courier (for
vivo blood level bioequivalence (BE) for [Docket No. FDA–2015–D–4361] written/paper submissions): Division of
veterinary pharmaceutical products. To Dockets Management (HFA–305), Food
Gifts to the Food and Drug and Drug Administration, 5630 Fishers
meet this objective, the guidance
Administration: Evaluation and Lane, Rm. 1061, Rockville, MD 20852.
addresses the following topics: A
Acceptance; Guidance for the Public • For written/paper comments
harmonized definition of BE, factors/
and Food and Drug Administration; submitted to the Division of Dockets
variables that should be considered
Availability Management, FDA will post your
when developing scientifically sound
blood level BE study designs, and AGENCY: Food and Drug Administration, comment, as well as any attachments,
information that should be included in HHS. except for information submitted,
a blood level BE study report. ACTION: Notice of availability. marked and identified, as confidential,
if submitted as detailed in
III. Significance of Guidance SUMMARY: The Food and Drug ‘‘Instructions.’’
This guidance, developed under the Administration (FDA, we, or Agency) is Instructions: All submissions received
mstockstill on DSK3G9T082PROD with NOTICES
VICH process, is being issued consistent announcing the availability of a must include the Docket No. FDA–
with FDA’s good guidance practices guidance for industry entitled ‘‘Gifts to 2015–D–4361 for ‘‘Gifts to FDA:
regulation (21 CFR 10.115). For FDA: Evaluation and Acceptance.’’ The Evaluation and Acceptance: Guidance
example, the document has been Secretary of the Department of Health for the Public and FDA Staff;
designated ‘‘guidance’’ rather than and Human Services (HHS) has the Availability.’’ Received comments will
‘‘guideline.’’ In addition, guidance authority to accept conditional or be placed in the docket and, except for
documents must not include mandatory unconditional gifts on behalf of the those submitted as ‘‘Confidential
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Document Created: 2018-02-14 09:07:44
Document Modified: 2018-02-14 09:07:44
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Marilyn Martinez, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0635, email: [email protected] | |
| FR Citation | 81 FR 91179 |
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