81 FR 14859 - Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 53 (March 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 53 (March 18, 2016)
| Page Range | 14859-14860 | |
| FR Document | 2016-06119 |
[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)] [Notices] [Pages 14859-14860] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06119] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0620] Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #234 entitled ``Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' In order to improve the process for submission and review of chemistry, manufacturing, and controls (CMC) information for animal drugs, the Center for Veterinary Medicine (CVM) has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. Termed Question-based Review (QbR), these questions provide a general framework for original CMC submissions to investigational new animal drug (INAD) files, generic investigational new animal drug (JINAD) files, new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), conditional approval of applications for conditional approval (CNADAs), and veterinary master files (VMFs). 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 17, 2016.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-2016-D-0620 for ``Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Julie Bailey, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0700, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Under sections 512(c)(2)(A)(i) and (d)(1)(C), and 571(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(A)(i) and (d)(1)(C), and 360ccc(c)(1)), applicants must submit information on CMC to support the approval of NADAs and ANADAs or the conditional approval of CNADAs. CVM reviews the CMC information for new animal drugs to ensure that applicants have methods and controls in place for manufacturing, processing, and packaging that are adequate for assuring [[Page 14860]] and preserving the identity, strength, quality, and purity of the new animal drug and, in the case of a generic drug, to ensure that it is equivalent to the reference listed new animal drug (RLNAD). In order to improve the process for submission and review of CMC information for animal drugs, CVM has developed draft GFI #234 entitled ``Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' This guidance contains a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. Termed QbR, these questions provide a general framework for original CMC submissions to INAD and JINAD files, NADAs, ANADAs, CNADAs, and VMFs. II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' 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 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(n)(1)) have been approved under OMB control number 0910-0669. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: March 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-06119 Filed 3-17-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices 14859
Dated: March 14, 2016. Comments submitted electronically, its consideration of comments. The
Leslie Kux, including attachments, to http:// second copy, which will have the
Associate Commissioner for Policy. www.regulations.gov will be posted to claimed confidential information
[FR Doc. 2016–06126 Filed 3–17–16; 8:45 am] the docket unchanged. Because your redacted/blacked out, will be available
BILLING CODE 4164–01–P comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your http://www.regulations.gov. Submit
comment does not include any both copies to the Division of Dockets
DEPARTMENT OF HEALTH AND confidential information that you or a Management. If you do not wish your
HUMAN SERVICES third party may not wish to be posted, name and contact information to be
such as medical information, your or made publicly available, you can
Food and Drug Administration anyone else’s Social Security number, or provide this information on the cover
[Docket No. FDA–2016–D–0620] confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
Question-Based Review for the that if you include your name, contact information as ‘‘confidential.’’ Any
Chemistry, Manufacturing, and information, or other information that information marked as ‘‘confidential’’
Controls Technical Section of Animal identifies you in the body of your will not be disclosed except in
Drug Applications; Draft Guidance for comments, that information will be accordance with 21 CFR 10.20 and other
Industry; Availability posted on http://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
AGENCY: Food and Drug Administration, with confidential information that you comments to public dockets, see 80 FR
HHS. do not wish to be made available to the 56469, September 18, 2015, or access
ACTION: Notice. public, submit the comment as a the information at: http://www.fda.gov/
written/paper submission and in the regulatoryinformation/dockets/
SUMMARY: The Food and Drug
manner detailed (see ‘‘Written/Paper default.htm.
Administration (FDA) is announcing the
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
availability of a draft guidance for
industry (GFI) #234 entitled ‘‘Question- Written/Paper Submissions read background documents or the
Based Review for the Chemistry, electronic and written/paper comments
Submit written/paper submissions as
Manufacturing, and Controls Technical received, go to http://
follows:
www.regulations.gov and insert the
Section of Animal Drug Applications.’’ • Mail/Hand delivery/Courier (for
In order to improve the process for docket number, found in brackets in the
written/paper submissions): Division of
submission and review of chemistry, heading of this document, into the
Dockets Management (HFA–305), Food
manufacturing, and controls (CMC) ‘‘Search’’ box and follow the prompts
and Drug Administration, 5630 Fishers
information for animal drugs, the Center and/or go to the Division of Dockets
Lane, Rm. 1061, Rockville, MD 20852.
for Veterinary Medicine (CVM) has • For written/paper comments Management, 5630 Fishers Lane, Rm.
developed a series of questions that submitted to the Division of Dockets 1061, Rockville, MD 20852.
focus on the critical scientific and Management, FDA will post your Submit written requests for single
regulatory issues and pharmaceutical comment, as well as any attachments, copies of the guidance to the Policy and
attributes essential for ensuring the except for information submitted, Regulations Staff (HFV–6), Center for
quality of new animal drug substances marked and identified, as confidential, Veterinary Medicine, Food and Drug
and products. Termed Question-based if submitted as detailed in Administration, 7519 Standish Pl.,
Review (QbR), these questions provide a ‘‘Instructions.’’ Rockville, MD 20855. Send one self-
general framework for original CMC Instructions: All submissions received addressed adhesive label to assist that
submissions to investigational new must include the Docket No. FDA– office in processing your requests. See
animal drug (INAD) files, generic 2016–D–0620 for ‘‘Question-Based the SUPPLEMENTARY INFORMATION section
investigational new animal drug Review for the Chemistry, for electronic access to the draft
(JINAD) files, new animal drug Manufacturing, and Controls Technical guidance document.
applications (NADAs), abbreviated new Section of Animal Drug Applications.’’ FOR FURTHER INFORMATION CONTACT: Julie
animal drug applications (ANADAs), Received comments will be placed in Bailey, Center for Veterinary Medicine
conditional approval of applications for the docket and, except for those (HFV–145), Food and Drug
conditional approval (CNADAs), and submitted as ‘‘Confidential Administration, 7500 Standish Pl.,
veterinary master files (VMFs). Submissions,’’ publicly viewable at Rockville, MD 20855, 240–402–0700,
DATES: Although you can comment on http://www.regulations.gov or at the julie.bailey@fda.hhs.gov.
any guidance at any time (see 21 CFR Division of Dockets Management SUPPLEMENTARY INFORMATION:
10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday
I. Background
considers your comment on this draft through Friday.
guidance before it begins work on the • Confidential Submissions—To Under sections 512(c)(2)(A)(i) and
final version of the guidance, submit submit a comment with confidential (d)(1)(C), and 571(c)(1) of the Federal
either electronic or written comments information that you do not wish to be Food, Drug, and Cosmetic Act (21 U.S.C.
on the draft guidance by May 17, 2016. made publicly available, submit your 360b(c)(2)(A)(i) and (d)(1)(C), and
comments only as a written/paper 360ccc(c)(1)), applicants must submit
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ADDRESSES: You may submit comments
as follows: submission. You should submit two information on CMC to support the
copies total. One copy will include the approval of NADAs and ANADAs or the
Electronic Submissions information you claim to be confidential conditional approval of CNADAs. CVM
Submit electronic comments in the with a heading or cover note that states reviews the CMC information for new
following way: ‘‘THIS DOCUMENT CONTAINS animal drugs to ensure that applicants
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The have methods and controls in place for
www.regulations.gov. Follow the Agency will review this copy, including manufacturing, processing, and
instructions for submitting comments. the claimed confidential information, in packaging that are adequate for assuring
VerDate Sep<11>2014 19:50 Mar 17, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1](https://thefederalregister.org/doc/81_FR_14912/page/1.svg)
![14860 Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices
and preserving the identity, strength, Dated: March 14, 2016. anyone else’s Social Security number, or
quality, and purity of the new animal Leslie Kux, confidential business information, such
drug and, in the case of a generic drug, Associate Commissioner for Policy. as a manufacturing process. Please note
to ensure that it is equivalent to the [FR Doc. 2016–06119 Filed 3–17–16; 8:45 am] that if you include your name, contact
reference listed new animal drug BILLING CODE 4164–01–P information, or other information that
(RLNAD). identifies you in the body of your
comments, that information will be
In order to improve the process for posted on http://www.regulations.gov.
DEPARTMENT OF HEALTH AND
submission and review of CMC • If you want to submit a comment
HUMAN SERVICES
information for animal drugs, CVM has with confidential information that you
developed draft GFI #234 entitled Food and Drug Administration do not wish to be made available to the
‘‘Question-Based Review for the public, submit the comment as a
[Docket No. FDA–2013–N–0663]
Chemistry, Manufacturing, and Controls written/paper submission and in the
Technical Section of Animal Drug Agency Information Collection manner detailed (see ‘‘Written/Paper
Applications.’’ This guidance contains a Activities; Proposed Collection; Submissions’’ and ‘‘Instructions’’).
series of questions that focus on the Comment Request; Investigational Written/Paper Submissions
critical scientific and regulatory issues New Drug Safety Reporting
and pharmaceutical attributes essential Requirements for Human Drug and Submit written/paper submissions as
for ensuring the quality of new animal Biological Products and Safety follows:
• Mail/Hand delivery/Courier (for
drug substances and products. Termed Reporting Requirements for
written/paper submissions): Division of
QbR, these questions provide a general Bioavailability and Bioequivalence
Dockets Management (HFA–305), Food
framework for original CMC Studies in Humans
and Drug Administration, 5630 Fishers
submissions to INAD and JINAD files, AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
NADAs, ANADAs, CNADAs, and VMFs. HHS. • For written/paper comments
II. Significance of Guidance ACTION: Notice. submitted to the Division of Dockets
Management, FDA will post your
This level 1 draft guidance is being SUMMARY: The Food and Drug comment, as well as any attachments,
issued consistent with FDA’s good Administration (FDA) is announcing an except for information submitted,
guidance practices regulation (21 CFR opportunity for public comment on the marked and identified, as confidential,
10.115). The draft guidance, when proposed collection of certain if submitted as detailed in
finalized, will represent the current information by the Agency. Under the ‘‘Instructions.’’
thinking of FDA on ‘‘Question-Based Paperwork Reduction Act of 1995 (the Instructions: All submissions received
PRA), Federal Agencies are required to must include the Docket No. FDA–
Review for the Chemistry,
publish notice in the Federal Register 2013–N–0663 for ‘‘Investigational New
Manufacturing, and Controls Technical
concerning each proposed collection of Drug Safety Reporting Requirements for
Section of Animal Drug Applications.’’
information, including each proposed Human Drug and Biological Products
It does not establish any rights for any extension of an existing collection of and Safety Reporting Requirements for
person and is not binding on FDA or the information, and to allow 60 days for Bioavailability and Bioequivalence
public. You can use an alternative public comment in response to the Studies in Humans.’’ Received
approach if it satisfies the requirements notice. This notice solicits comments on comments will be placed in the docket
of the applicable statutes and Investigational New Drug Safety and, except for those submitted as
regulations. Reporting Requirements for Human ‘‘Confidential Submissions,’’ publicly
III. Paperwork Reduction Act of 1995 Drug and Biological Products and Safety viewable at http://www.regulations.gov
Reporting Requirements for or at the Division of Dockets
This draft guidance refers to Bioavailability and Bioequivalence Management between 9 a.m. and 4 p.m.,
previously approved collections of Studies in Humans. Monday through Friday.
information found in FDA regulations. DATES: Submit either electronic or • Confidential Submissions—To
These collections of information are written comments on the collection of submit a comment with confidential
subject to review by the Office of information by May 17, 2016. information that you do not wish to be
Management and Budget (OMB) under ADDRESSES: You may submit comments made publicly available, submit your
the Paperwork Reduction Act of 1995 as follows: comments only as a written/paper
(44 U.S.C. 3501–3520). The collections submission. You should submit two
Electronic Submissions copies total. One copy will include the
of information in 21 CFR part 514 have
been approved under OMB control Submit electronic comments in the information you claim to be confidential
number 0910–0032; the collections of following way: with a heading or cover note that states
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
information in section 512(n)(1) of the
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
FD&C Act (21 U.S.C. 360b(n)(1)) have
instructions for submitting comments. Agency will review this copy, including
been approved under OMB control
Comments submitted electronically, the claimed confidential information, in
number 0910–0669. its consideration of comments. The
including attachments, to http://
asabaliauskas on DSK3SPTVN1PROD with NOTICES
IV. Electronic Access www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
Persons with access to the Internet comment will be made public, you are redacted/blacked out, will be available
may obtain the draft guidance at either solely responsible for ensuring that your for public viewing and posted on
http://www.fda.gov/AnimalVeterinary/ comment does not include any http://www.regulations.gov. Submit
GuidanceComplianceEnforcement/ confidential information that you or a both copies to the Division of Dockets
GuidanceforIndustry/default.htm or third party may not wish to be posted, Management. If you do not wish your
http://www.regulations.gov. such as medical information, your or name and contact information to be
VerDate Sep<11>2014 19:50 Mar 17, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1](https://thefederalregister.org/doc/81_FR_14912/page/2.svg)
Document Created: 2018-02-02 15:14:08
Document Modified: 2018-02-02 15:14:08
| 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 | 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 May 17, 2016. | |
| Contact | Julie Bailey, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0700, [email protected] | |
| FR Citation | 81 FR 14859 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR