81 FR 19195 - Comparability Protocols-Chemistry, Manufacturing, and Controls Information for New Animal Drugs; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 64 (April 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 64 (April 4, 2016)
| Page Range | 19195-19196 | |
| FR Document | 2016-07573 |
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)] [Notices] [Pages 19195-19196] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07573] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0938 (formerly FDA-2003-D-0034 and 2003D-0061)] Comparability Protocols--Chemistry, Manufacturing, and Controls Information for New Animal Drugs; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#156) entitled ``Comparability Protocols--Chemistry, Manufacturing, and Controls Information for New Animal Drugs.'' This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations to industry regarding comparability protocols that would be submitted in new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or supplements to these applications. This guidance also applies to comparability protocols submitted in investigational new animal drug (INAD), generic investigational new animal drug (JINAD), and veterinary master file (VMF) submissions that are referenced in applications. FDA is providing this guidance in response to requests from those interested in using comparability protocols. 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: 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-2016-D-0938 for ``Comparability [[Page 19196]] Protocols--Chemistry, Manufacturing, and Controls Information for New Animal Drugs.'' 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 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: Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0696, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 25, 2003 (68 FR 8772), FDA published the notice of availability for a draft guidance for industry entitled ``Comparability Protocols--Chemistry, Manufacturing, and Controls Information,'' giving interested persons until June 25, 2003, to comment on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes include describing comparability protocols submitted in CMC (J)INAD technical data submissions or (J)INAD protocols without substantial data. In accordance with the performance goals and procedures for the ADUFA and AGDUFA reauthorizations for fiscal years 2014 through 2018, comparability protocols may be submitted as comparability protocols without substantial data in a (J)INAD file. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated February 2003 only as it applies to the preparation and submission to the Center for Veterinary Medicine of comparability protocols for postapproval changes in CMC information for new animal drugs. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on Comparability Protocols--Chemistry, Manufacturing, and Controls Information for New Animal Drugs. 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 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. 360b) have been approved under OMB control number 0910-0669. IV. 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: March 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-07573 Filed 4-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices 19195
licensure pathway for biological approved under OMB control number supplements to these applications. This
products demonstrated to be biosimilar 0910–0719; the collections of guidance also applies to comparability
to or interchangeable with a reference information under 21 CFR 201.57 for the protocols submitted in investigational
product. Section 351(k) of the PHS Act submission of labeling have been new animal drug (INAD), generic
(42 U.S.C. 262(k)), added by the BPCI approved under OMB control number investigational new animal drug
Act, sets forth the requirements for an 0910–0572; the collections of (JINAD), and veterinary master file
application for a proposed biosimilar information under 21 CFR part 600 for (VMF) submissions that are referenced
product and an application or the submission of adverse experience in applications. FDA is providing this
supplement for a proposed reporting for licensed biological guidance in response to requests from
interchangeable product. Under section products and general records have been those interested in using comparability
351(k) of the PHS Act, a proposed approved under OMB control number protocols.
biological product that is demonstrated 0910–0308; and the collections of DATES: Submit either electronic or
to be biosimilar to a reference product information under 21 CFR part 600 for written comments on Agency guidances
can rely on certain existing scientific the submission of MedWatch reporting at any time.
knowledge about the safety, purity, and forms (FDA Form 3500 and FDA Form
ADDRESSES: You may submit comments
potency of the reference product to 3500A) have been approved under OMB
support licensure, and this is reflected control number 0910–0291. as follows:
in the approach to biosimilar product Electronic Submissions
III. Electronic Access
labeling.
In this draft guidance, FDA outlines Persons with access to the Internet Submit electronic comments in the
its recommendations for biosimilar may obtain the draft guidance at http:// following way:
product labeling. A demonstration of www.fda.gov/Drugs/Guidance • Federal eRulemaking Portal: http://
biosimilarity means, among other ComplianceRegulatoryInformation/ www.regulations.gov. Follow the
things, that FDA has determined that Guidances/default.htm, http:// instructions for submitting comments.
there are no clinically meaningful www.fda.gov/BiologicsBloodVaccines/ Comments submitted electronically,
differences between the proposed GuidanceComplianceRegulatory including attachments, to http://
product and the reference product in Information/Guidances/default.htm, or www.regulations.gov will be posted to
terms of safety, purity and potency. http://www.regulations.gov. the docket unchanged. Because your
Accordingly, biosimilar applicants comment will be made public, you are
Dated: March 29, 2016. solely responsible for ensuring that your
should incorporate relevant data and Leslie Kux,
information from the reference product comment does not include any
Associate Commissioner for Policy. confidential information that you or a
labeling, with appropriate product-
specific modifications as described in [FR Doc. 2016–07611 Filed 4–1–16; 8:45 am] third party may not wish to be posted,
the draft guidance. BILLING CODE 4164–01–P such as medical information, your or
We invite comment on the draft anyone else’s Social Security number, or
guidance, including whether patient confidential business information, such
labeling (e.g., Patient Information, DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
Medication Guide, and Instructions for HUMAN SERVICES that if you include your name, contact
Use) should include a biosimilarity information, or other information that
Food and Drug Administration
statement similar to the statement identifies you in the body of your
described in section IV.C.1 of the draft [Docket No. FDA–2016–D–0938 (formerly comments, that information will be
guidance. FDA–2003–D–0034 and 2003D–0061)] posted on http://www.regulations.gov.
This draft guidance is being issued • If you want to submit a comment
Comparability Protocols—Chemistry, with confidential information that you
consistent with FDA’s good guidance
Manufacturing, and Controls do not wish to be made available to the
practices regulation (21 CFR 10.115).
Information for New Animal Drugs; public, submit the comment as a
The draft guidance, when finalized, will
Guidance for Industry; Availability written/paper submission and in the
represent the current thinking of FDA
on labeling for biosimilar products. It AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
does not establish any rights for any HHS. Submissions’’ and ‘‘Instructions’’).
person and is not binding on FDA or the ACTION: Notice of availability. Written/Paper Submissions
public. You can use an alternative
approach if it satisfies the requirements SUMMARY: The Food and Drug Submit written/paper submissions as
of the applicable statutes and Administration (FDA) is announcing the follows:
regulations. availability of a final guidance for • Mail/Hand delivery/Courier (for
industry (#156) entitled ‘‘Comparability written/paper submissions): Division of
II. The Paperwork Reduction Act of Protocols—Chemistry, Manufacturing, Dockets Management (HFA–305), Food
1995 and Controls Information for New and Drug Administration, 5630 Fishers
This draft guidance refers to Animal Drugs.’’ This document Lane, Rm. 1061, Rockville, MD 20852.
previously approved collections of provides recommendations to • For written/paper comments
information found in FDA regulations. applicants on preparing and using submitted to the Division of Dockets
These collections of information are comparability protocols for Management, FDA will post your
mstockstill on DSK4VPTVN1PROD with NOTICES
subject to review by the Office of postapproval changes in chemistry, comment, as well as any attachments,
Management and Budget (OMB) under manufacturing, and controls (CMC) except for information submitted,
the Paperwork Reduction Act (PRA) of information. It is intended to provide marked and identified, as confidential,
1995 (44 U.S.C. 3501–3520). The recommendations to industry regarding if submitted as detailed in
collections of information under 21 CFR comparability protocols that would be ‘‘Instructions.’’
part 601 for the submission of a submitted in new animal drug Instructions: All submissions received
biologics license application under applications (NADAs), abbreviated new must include the Docket No. FDA–
section 351(k) of the PHS Act have been animal drug applications (ANADAs), or 2016–D–0938 for ‘‘Comparability
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![19196 Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
Protocols—Chemistry, Manufacturing, FOR FURTHER INFORMATION CONTACT: 360b) have been approved under OMB
and Controls Information for New Dennis Bensley, Center for Veterinary control number 0910–0669.
Animal Drugs.’’ Received comments Medicine (HFV–140), Food and Drug
IV. Electronic Access
will be placed in the docket and, except Administration, 7500 Standish Pl.,
for those submitted as ‘‘Confidential Rockville, MD 20855, 240–402–0696, Persons with access to the Internet
Submissions,’’ publicly viewable at dennis.bensley@fda.hhs.gov. may obtain the guidance at either http://
http://www.regulations.gov or at the SUPPLEMENTARY INFORMATION: www.fda.gov/AnimalVeterinary/
Division of Dockets Management GuidanceComplianceEnforcement/
between 9 a.m. and 4 p.m., Monday I. Background GuidanceforIndustry/default.htm or
through Friday. In the Federal Register of February http://www.regulations.gov.
• Confidential Submissions—To 25, 2003 (68 FR 8772), FDA published Dated: March 29, 2016.
submit a comment with confidential the notice of availability for a draft Leslie Kux,
information that you do not wish to be guidance for industry entitled
Associate Commissioner for Policy.
made publicly available, submit your ‘‘Comparability Protocols—Chemistry,
comments only as a written/paper Manufacturing, and Controls [FR Doc. 2016–07573 Filed 4–1–16; 8:45 am]
submission. You should submit two Information,’’ giving interested persons BILLING CODE 4164–01–P
copies total. One copy will include the until June 25, 2003, to comment on the
information you claim to be confidential draft guidance and those comments
with a heading or cover note that states were considered as the guidance was DEPARTMENT OF HEALTH AND
‘‘THIS DOCUMENT CONTAINS finalized. A summary of changes HUMAN SERVICES
CONFIDENTIAL INFORMATION.’’ The include describing comparability Food and Drug Administration
Agency will review this copy, including protocols submitted in CMC (J)INAD
the claimed confidential information, in technical data submissions or (J)INAD [Docket No. FDA–2004–N–0451]
its consideration of comments. The protocols without substantial data. In
second copy, which will have the accordance with the performance goals Food and Drug Administration
claimed confidential information and procedures for the ADUFA and Modernization Act of 1997:
redacted/blacked out, will be available AGDUFA reauthorizations for fiscal Modifications to the List of Recognized
for public viewing and posted on http:// years 2014 through 2018, comparability Standards, Recognition List Number:
www.regulations.gov. Submit both protocols may be submitted as 041
copies to the Division of Dockets comparability protocols without AGENCY: Food and Drug Administration,
Management. If you do not wish your substantial data in a (J)INAD file. In HHS.
name and contact information to be addition, editorial changes were made
made publicly available, you can to improve clarity. The guidance ACTION: Notice.
provide this information on the cover announced in this notice finalizes the SUMMARY: The Food and Drug
sheet and not in the body of your draft guidance dated February 2003 only Administration (FDA or Agency) is
comments and you must identify this as it applies to the preparation and announcing a publication containing
information as ‘‘confidential.’’ Any submission to the Center for Veterinary modifications the Agency is making to
information marked as ‘‘confidential’’ Medicine of comparability protocols for the list of standards FDA recognizes for
will not be disclosed except in postapproval changes in CMC use in premarket reviews (FDA
accordance with 21 CFR 10.20 and other information for new animal drugs. Recognized Consensus Standards). This
applicable disclosure law. For more publication, entitled ‘‘Modifications to
information about FDA’s posting of II. Significance of Guidance
the List of Recognized Standards,
comments to public dockets, see 80 FR This level 1 guidance is being issued
Recognition List Number: 041’’
56469, September 18, 2015, or access consistent with FDA’s good guidance
(Recognition List Number: 041), will
the information at: http://www.fda.gov/ practices regulation (21 CFR 10.115).
assist manufacturers who elect to
regulatoryinformation/dockets/ This guidance represents the current
declare conformity with consensus
default.htm. thinking of FDA on Comparability
standards to meet certain requirements
Docket: For access to the docket to Protocols—Chemistry, Manufacturing,
read background documents or the for medical devices.
and Controls Information for New
electronic and written/paper comments Animal Drugs. It does not establish any DATES: Submit electronic or written
received, go to http:// rights for any person and is not binding comments concerning this document at
www.regulations.gov and insert the on FDA or the public. You can use an any time. These modifications to the list
docket number, found in brackets in the alternative approach if it satisfies the of recognized standards are effective
heading of this document, into the requirements of the applicable statutes April 4, 2016.
‘‘Search’’ box and follow the prompts and regulations. ADDRESSES: You may submit comments
and/or go to the Division of Dockets as follows:
Management, 5630 Fishers Lane, Rm. III. Paperwork Reduction Act of 1995
This guidance refers to previously Electronic Submissions
1061, Rockville, MD 20852.
Submit written requests for single approved collections of information Submit electronic comments in the
copies of the guidance to the Policy and found in FDA regulations. These following way:
Regulations Staff (HFV–6), Center for collections of information are subject to • Federal eRulemaking Portal: http://
mstockstill on DSK4VPTVN1PROD with NOTICES
Veterinary Medicine, Food and Drug review by the Office of Management and www.regulations.gov. Follow the
Administration, 7519 Standish Pl., Budget (OMB) under the Paperwork instructions for submitting comments.
Rockville, MD 20855. Send one self- Reduction Act of 1995 (44 U.S.C. 3501– Comments submitted electronically,
addressed adhesive label to assist that 3520). The collections of information in including attachments, to http://
office in processing your requests. See 21 CFR part 514 have been approved www.regulations.gov will be posted to
the SUPPLEMENTARY INFORMATION section under OMB control number 0910–0032; the docket unchanged. Because your
for electronic access to the guidance the collections of information in section comment will be made public, you are
document. 512(n)(1) of the FD&C Act (21 U.S.C. solely responsible for ensuring that your
VerDate Sep<11>2014 19:03 Apr 01, 2016 Jkt 238001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1](https://thefederalregister.org/doc/81_FR_19259/page/2.svg)
Document Created: 2016-04-02 03:53:00
Document Modified: 2016-04-02 03:53:00
| 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 Agency guidances at any time. | |
| Contact | Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0696, [email protected] | |
| FR Citation | 81 FR 19195 |
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