81 FR 63775 - Waivers From the Requirement To Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Draft Revised Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 180 (September 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 180 (September 16, 2016)
| Page Range | 63775-63776 | |
| FR Document | 2016-22339 |
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)] [Notices] [Pages 63775-63776] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22339] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-D-0045] Waivers From the Requirement To Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Draft Revised 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 revised guidance for industry (GFI) #171 entitled ``Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' This draft revised guidance document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. It expands upon CVM's Bioequivalence Guidance,\1\ particularly the section on Criteria for Waiver of In Vivo Bioequivalence Study. This guidance is applicable to generic investigational new animal drug (JINAD) files and abbreviated new animal drug applications (ANADAs). Although the recommendations in this guidance reference generic drug applications, the general principles described may also be applicable to new animal drug applications (NADAs), investigational new animal drug (INAD) files, and supplemental NADAs. --------------------------------------------------------------------------- \1\ CVM Guidance for Industry #35, ``Bioequivalence Guidance,'' November 8, 2006 (see page 7): http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052363.pdf. 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 revised guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft --------------------------------------------------------------------------- revised guidance by November 15, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-2004-D-0045 for ``Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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 http://www.regulations.gov and insert the docket number, found in brackets in the [[Page 63776]] 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 draft revised guidance document. FOR FURTHER INFORMATION CONTACT: Charli Long, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0850, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft revised guidance for industry #171 entitled ``Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' This draft revised guidance document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. It expands upon CVM's Bioequivalence Guidance,\2\ particularly the section on Criteria for Waiver of In Vivo Bioequivalence Study. This draft revised guidance document is intended to provide clarification of the scientific basis for concepts and recommendations conveyed in the original guidance. In addition, the table containing estimated gastric volumes for each of the various animal species has been revised. However, applicants may propose an alternative gastric volume value for a particular species when using the dosage adjusted approach. No new concepts have been introduced in this draft revised guidance and its scope has not been modified. --------------------------------------------------------------------------- \2\ CVM Guidance for Industry #35, ``Bioequivalence Guidance,'' November 8, 2006 (see page 7): http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052363.pdf. --------------------------------------------------------------------------- II. Significance of Guidance This level 1 draft revised guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft revised guidance, when finalized, will represent the current thinking of FDA on ``Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' 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. III. Paperwork Reduction Act of 1995 This draft revised guidance refers to previously approved collections of information that 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 referred to in the guidance entitled ``Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles'' have been approved under OMB control number 0910-0575. IV. Electronic Access Persons with access to the Internet may obtain the draft revised guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: September 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22339 Filed 9-15-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63775
The Agency encourages individuals, CVM’s Bioequivalence Guidance,1 Dockets Management (HFA–305), Food
industry, device manufacturers, health particularly the section on Criteria for and Drug Administration, 5630 Fishers
care professionals, researchers, public Waiver of In Vivo Bioequivalence Lane, Rm. 1061, Rockville, MD 20852.
health organizations and other Study. This guidance is applicable to • For written/paper comments
interested persons to attend this public generic investigational new animal drug submitted to the Division of Dockets
workshop. Workshop updates will be (JINAD) files and abbreviated new Management, FDA will post your
made available on the internet at http:// animal drug applications (ANADAs). comment, as well as any attachments,
www.fda.gov/Drugs/NewsEvents/ Although the recommendations in this except for information submitted,
ucm512519.htm. guidance reference generic drug marked and identified, as confidential,
Transcripts: Please be advised that as applications, the general principles if submitted as detailed in
soon as a transcript is available, it will described may also be applicable to new ‘‘Instructions.’’
be accessible at http:// animal drug applications (NADAs), Instructions: All submissions received
www.regulations.gov. It may be viewed investigational new animal drug (INAD) must include the Docket No. FDA–
at the Division of Dockets Management files, and supplemental NADAs. 2004–D–0045 for ‘‘Waivers from the
(HFA–305), Food and Drug DATES: Although you can comment on Requirement to Demonstrate
Administration, 5630 Fishers Lane, Rm. any guidance at any time (see 21 CFR Bioequivalence of Animal Drugs in
1061, Rockville, MD. A transcript will 10.115(g)(5)), to ensure that the Agency Soluble Powder Oral Dosage Form
also be available either in hardcopy or considers your comment on this draft Products and Type A Medicated
on CD–ROM, after submission of a revised guidance before it begins work Articles.’’ Received comments will be
Freedom of Information request. The on the final version of the guidance, placed in the docket and, except for
Freedom of Information office address is submit either electronic or written those submitted as ‘‘Confidential
available on the Agency’s Web site at comments on the draft revised guidance Submissions,’’ publicly viewable at
http://www.fda.gov. Transcripts will by November 15, 2016. http://www.regulations.gov or at the
also be available on the Internet at ADDRESSES: You may submit comments
Division of Dockets Management
http://www.fda.gov/Drugs/NewsEvents/ as follows: between 9 a.m. and 4 p.m., Monday
ucm512519.htm approximately 45 days through Friday.
Electronic Submissions • Confidential Submissions—To
after the workshop.
Submit electronic comments in the submit a comment with confidential
Dated: September 9, 2016. information that you do not wish to be
following way:
Leslie Kux, • Federal eRulemaking Portal: http:// made publicly available, submit your
Associate Commissioner for Policy. www.regulations.gov. Follow the comments only as a written/paper
[FR Doc. 2016–22352 Filed 9–15–16; 8:45 am] instructions for submitting comments. submission. You should submit two
BILLING CODE 4164–01–P Comments submitted electronically, copies total. One copy will include the
including attachments, to http:// information you claim to be confidential
www.regulations.gov will be posted to with a heading or cover note that states
DEPARTMENT OF HEALTH AND the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
HUMAN SERVICES comment will be made public, you are CONFIDENTIAL INFORMATION.’’ The
solely responsible for ensuring that your Agency will review this copy, including
Food and Drug Administration comment does not include any the claimed confidential information, in
confidential information that you or a its consideration of comments. The
[Docket No. FDA–2004–D–0045]
third party may not wish to be posted, second copy, which will have the
Waivers From the Requirement To such as medical information, your or claimed confidential information
Demonstrate Bioequivalence of Animal anyone else’s Social Security number, or redacted/blacked out, will be available
Drugs in Soluble Powder Oral Dosage confidential business information, such for public viewing and posted on http://
Form Products and Type A Medicated as a manufacturing process. Please note www.regulations.gov. Submit both
Articles; Draft Revised Guidance for that if you include your name, contact copies to the Division of Dockets
Industry; Availability information, or other information that Management. If you do not wish your
identifies you in the body of your name and contact information to be
AGENCY: Food and Drug Administration, comments, that information will be made publicly available, you can
HHS. posted on http://www.regulations.gov. provide this information on the cover
ACTION: Notice of availability. • If you want to submit a comment sheet and not in the body of your
with confidential information that you comments and you must identify this
SUMMARY: The Food and Drug do not wish to be made available to the information as ‘‘confidential.’’ Any
Administration (FDA or Agency) is public, submit the comment as a information marked as ‘‘confidential’’
announcing the availability of a draft written/paper submission and in the will not be disclosed except in
revised guidance for industry (GFI) #171 manner detailed (see ‘‘Written/Paper accordance with 21 CFR 10.20 and other
entitled ‘‘Waivers from the Requirement Submissions’’ and ‘‘Instructions’’). applicable disclosure law. For more
to Demonstrate Bioequivalence of information about FDA’s posting of
Animal Drugs in Soluble Powder Oral Written/Paper Submissions comments to public dockets, see 80 FR
Dosage Form Products and Type A Submit written/paper submissions as 56469, September 18, 2015, or access
Medicated Articles.’’ This draft revised follows: the information at: http://www.fda.gov/
guidance document describes how the • Mail/Hand delivery/Courier (for regulatoryinformation/dockets/
mstockstill on DSK3G9T082PROD with NOTICES
Center for Veterinary Medicine (CVM) written/paper submissions): Division of default.htm.
intends to evaluate requests for waiving Docket: For access to the docket to
the requirement for submitting data 1 CVM Guidance for Industry #35, read background documents or the
demonstrating the bioequivalence of ‘‘Bioequivalence Guidance,’’ November 8, 2006 (see electronic and written/paper comments
page 7): http://www.fda.gov/downloads/
animal drugs in soluble powder oral AnimalVeterinary/
received, go to http://
dosage form products and Type A GuidanceComplianceEnforcement/ www.regulations.gov and insert the
medicated articles. It expands upon GuidanceforIndustry/UCM052363.pdf. docket number, found in brackets in the
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![63776 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices
heading of this document, into the guidance practices regulation (21 CFR DATES: See ‘‘How to Participate in the
‘‘Search’’ box and follow the prompts 10.115). The draft revised guidance, Public Meeting’’ in the SUPPLEMENTARY
and/or go to the Division of Dockets when finalized, will represent the INFORMATION section of this document
Management, 5630 Fishers Lane, Rm. current thinking of FDA on ‘‘Waivers for dates, times, and addresses of the
1061, Rockville, MD 20852. from the Requirement to Demonstrate public meeting, closing date for advance
Submit written requests for single Bioequivalence of Animal Drugs in registration, requesting special
copies of the guidance to the Policy and Soluble Powder Oral Dosage Form accommodations due to disability, and
Regulations Staff (HFV–6), Center for Products and Type A Medicated other information.
Veterinary Medicine, Food and Drug Articles.’’ It does not establish any ADDRESSES: See ‘‘How to Participate in
Administration, 7519 Standish Pl., rights for any person and is not binding the Public Meeting’’ in the
Rockville, MD 20855. Send one self- on FDA or the public. You can use an SUPPLEMENTARY INFORMATION section of
addressed adhesive label to assist that alternative approach if it satisfies the this document.
office in processing your requests. See requirements of the applicable statutes FOR FURTHER INFORMATION CONTACT: For
the SUPPLEMENTARY INFORMATION section and regulations. questions about registering for this
for electronic access to the draft revised
III. Paperwork Reduction Act of 1995 meeting or for special accommodations
guidance document.
This draft revised guidance refers to due to disability, contact Cindy de
FOR FURTHER INFORMATION CONTACT:
previously approved collections of Sales, The Event Planning Group, 8720
Charli Long, Center for Veterinary Georgia Ave., Suite 801, Silver Spring,
Medicine (HFV–170), Food and Drug information that are subject to review by
the Office of Management and Budget MD 20910, 240–316–3207, FAX: 240–
Administration, 7500 Standish Pl., 652–6002, email: rsvp@tepgevents.com.
Rockville, MD 20855, 240–402–0850, (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The For general questions about the public
charli.long-medrano@fda.hhs.gov. meeting, contact Loretta A. Carey,
SUPPLEMENTARY INFORMATION: collections of information referred to in
the guidance entitled ‘‘Waivers from the Center for Food Safety and Applied
I. Background Requirement to Demonstrate Nutrition (HFS–820), Food and Drug
Bioequivalence of Animal Drugs in Administration, 5001 Campus Dr.,
FDA is announcing the availability of
Soluble Powder Oral Dosage Form College Park, MD 20740, 240–402–2371.
a draft revised guidance for industry
#171 entitled ‘‘Waivers from the Products and Type A Medicated SUPPLEMENTARY INFORMATION:
Requirement to Demonstrate Articles’’ have been approved under I. Background
Bioequivalence of Animal Drugs in OMB control number 0910–0575.
In the Federal Register of December 1,
Soluble Powder Oral Dosage Form
IV. Electronic Access 2014 (79 FR 71156), we published a
Products and Type A Medicated
Articles.’’ This draft revised guidance Persons with access to the Internet final rule on nutrition labeling of
document describes how the Center for may obtain the draft revised guidance at standard menu items in restaurants and
Veterinary Medicine (CVM) intends to either http://www.fda.gov/ similar retail food establishments; the
evaluate requests for waiving the AnimalVeterinary/ rule is codified at Title 21 of the Code
requirement for submitting data GuidanceComplianceEnforcement/ of Federal Regulations, section 101.11.
demonstrating the bioequivalence of GuidanceforIndustry/default.htm or The final rule implements section
animal drugs in soluble powder oral http://www.regulations.gov. 403(q)(5)(H) of the Federal Food, Drug,
dosage form products and Type A and Cosmetic Act (the FD&C Act) (21
Dated: September 9, 2016.
medicated articles. It expands upon U.S.C. 343(q)(5)(H)), which, in general,
Leslie Kux, requires that restaurants and similar
CVM’s Bioequivalence Guidance,2 Associate Commissioner for Policy.
particularly the section on Criteria for retail food establishments that are part
[FR Doc. 2016–22339 Filed 9–15–16; 8:45 am] of a chain with 20 or more locations,
Waiver of In Vivo Bioequivalence
Study. This draft revised guidance
BILLING CODE 4164–01–P doing business under the same name,
document is intended to provide and offering for sale substantially the
clarification of the scientific basis for same menu items, provide calorie
DEPARTMENT OF HEALTH AND information for standard menu items
concepts and recommendations HUMAN SERVICES
conveyed in the original guidance. In (including food on display and self-
addition, the table containing estimated service food); provide, upon request,
Food and Drug Administration
gastric volumes for each of the various additional written nutrition information
animal species has been revised. [Docket No. FDA–2016–N–0001] for standard menu items; and comply
However, applicants may propose an with other requirements described in
Menu Labeling Public Workshop; section 403(q)(5)(H) of the FD&C Act.
alternative gastric volume value for a Public Meeting
particular species when using the On December 18, 2015, the President
dosage adjusted approach. No new AGENCY: Food and Drug Administration, signed the Consolidated Appropriations
concepts have been introduced in this HHS. Act, 2016 (Pub. L. 114–113). Section 747
draft revised guidance and its scope has ACTION: Notice of public meeting. of the Consolidated Appropriations Act
not been modified. states that none of the funds made
SUMMARY: The Food and Drug available under the Consolidated
II. Significance of Guidance Administration (FDA or we) is Appropriations Act may be used to
This level 1 draft revised guidance is announcing a third public meeting to implement, administer, or enforce the
mstockstill on DSK3G9T082PROD with NOTICES
being issued consistent with FDA’s good discuss menu labeling requirements. We final rule entitled ‘‘Food Labeling;
announced the first two public meetings Nutrition Labeling of Standard Menu
2 CVM Guidance for Industry #35, in a separate Federal Register notice Items in Restaurants and Similar Retail
‘‘Bioequivalence Guidance,’’ November 8, 2006 (see earlier this year. The purpose of the Food Establishments’’ until 1 year after
page 7): http://www.fda.gov/downloads/
AnimalVeterinary/
public meetings is to help the regulated the date of publication of a Level 1
GuidanceComplianceEnforcement/ industry comply with the requirements guidance with respect to nutrition
GuidanceforIndustry/UCM052363.pdf. of the menu labeling final rule. labeling of standard menu items in
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Document Created: 2016-09-16 00:24:29
Document Modified: 2016-09-16 00:24:29
| 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 | 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 revised guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft | |
| Contact | Charli Long, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0850, [email protected] | |
| FR Citation | 81 FR 63775 |
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