81 FR 92834 - Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 244 (December 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 244 (December 20, 2016)
| Page Range | 92834-92835 | |
| FR Document | 2016-30613 |
[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)] [Notices] [Pages 92834-92835] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30613] [[Page 92834]] ----------------------------------------------------------------------- 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; 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 guidance for industry #234 entitled ``Question- Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' To improve the process for submission and review of chemistry, manufacturing, and controls (CMC) information for animal drugs, the Center for Veterinary Medicine 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, these questions provide a general framework for original CMC submissions to investigational new animal drug files, generic investigational new animal drug files, new animal drug applications, abbreviated new animal drug applications, conditional approval of applications for conditional approval, and veterinary master files. 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- 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 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: 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 In the Federal Register of March 18, 2016 (81 FR 14859), FDA published the notice of availability for a draft guidance entitled ``Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications'' giving interested persons until May 17, 2016, to comment on the draft guidance. FDA received no comments on the draft guidance. The guidance announced in this notice finalizes the draft guidance dated March 2016. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents 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 [[Page 92835]] 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(n)(1)) 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 https://www.regulations.gov. Dated: December 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-30613 Filed 12-19-16; 8:45 am] BILLING CODE 4164-01-P
![92834 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
DEPARTMENT OF HEALTH AND information, or other information that information marked as ‘‘confidential’’
HUMAN SERVICES identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
Food and Drug Administration posted on https://www.regulations.gov. applicable disclosure law. For more
[Docket No. FDA–2016–D–0620]
• If you want to submit a comment information about FDA’s posting of
with confidential information that you comments to public dockets, see 80 FR
Question-Based Review for the do not wish to be made available to the 56469, September 18, 2015, or access
Chemistry, Manufacturing, and public, submit the comment as a the information at: http://www.fda.gov/
Controls Technical Section of Animal written/paper submission and in the regulatoryinformation/dockets/
Drug Applications; Guidance for manner detailed (see ‘‘Written/Paper default.htm.
Industry; Availability Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Written/Paper Submissions read background documents or the
AGENCY: Food and Drug Administration, electronic and written/paper comments
HHS. Submit written/paper submissions as received, go to https://
ACTION: Notice of availability. follows: www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
SUMMARY: The Food and Drug written/paper submissions): Division of
Administration (FDA or Agency) is heading of this document, into the
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
announcing the availability of a and Drug Administration, 5630 Fishers
guidance for industry #234 entitled and/or go to the Division of Dockets
Lane, Rm. 1061, Rockville, MD 20852.
Management, 5630 Fishers Lane, Rm.
‘‘Question-Based Review for the • For written/paper comments
Chemistry, Manufacturing, and Controls 1061, Rockville, MD 20852.
submitted to the Division of Dockets
Technical Section of Animal Drug Submit written requests for single
Management, FDA will post your
Applications.’’ To improve the process copies of the guidance to the Policy and
comment, as well as any attachments,
for submission and review of chemistry, Regulations Staff (HFV–6), Center for
except for information submitted,
manufacturing, and controls (CMC) Veterinary Medicine, Food and Drug
marked and identified, as confidential,
information for animal drugs, the Center if submitted as detailed in Administration, 7519 Standish Pl.,
for Veterinary Medicine has developed ‘‘Instructions.’’ Rockville, MD 20855. Send one self-
a series of questions that focus on the addressed adhesive label to assist that
Instructions: All submissions received office in processing your requests. See
critical scientific and regulatory issues must include the Docket No. FDA–
and pharmaceutical attributes essential the SUPPLEMENTARY INFORMATION section
2016–D–0620 for ‘‘Question-Based
for ensuring the quality of new animal for electronic access to the guidance
Review for the Chemistry,
drug substances and products. Termed document.
Manufacturing, and Controls Technical
Question-based Review, these questions Section of Animal Drug Applications.’’ FOR FURTHER INFORMATION CONTACT: Julie
provide a general framework for original Received comments will be placed in Bailey, Center for Veterinary Medicine
CMC submissions to investigational new the docket and, except for those (HFV–145), Food and Drug
animal drug files, generic submitted as ‘‘Confidential Administration, 7500 Standish Pl.,
investigational new animal drug files, Submissions,’’ publicly viewable at Rockville, MD 20855, 240–402–0700,
new animal drug applications, https://www.regulations.gov or at the julie.bailey@fda.hhs.gov.
abbreviated new animal drug Division of Dockets Management SUPPLEMENTARY INFORMATION:
applications, conditional approval of between 9 a.m. and 4 p.m., Monday
applications for conditional approval, through Friday. I. Background
and veterinary master files. • Confidential Submissions—To In the Federal Register of March 18,
DATES: Submit either electronic or submit a comment with confidential 2016 (81 FR 14859), FDA published the
written comments on Agency guidances information that you do not wish to be notice of availability for a draft guidance
at any time. made publicly available, submit your entitled ‘‘Question-Based Review for the
ADDRESSES: You may submit comments comments only as a written/paper Chemistry, Manufacturing, and Controls
as follows: submission. You should submit two Technical Section of Animal Drug
copies total. One copy will include the Applications’’ giving interested persons
Electronic Submissions information you claim to be confidential until May 17, 2016, to comment on the
Submit electronic comments in the with a heading or cover note that states draft guidance. FDA received no
following way: ‘‘THIS DOCUMENT CONTAINS comments on the draft guidance. The
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The guidance announced in this notice
https://www.regulations.gov. Follow the Agency will review this copy, including finalizes the draft guidance dated March
instructions for submitting comments. the claimed confidential information, in 2016.
Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the II. Significance of Guidance
www.regulations.gov will be posted to claimed confidential information This level 1 guidance is being issued
the docket unchanged. Because your redacted/blacked out, will be available consistent with FDA’s good guidance
comment will be made public, you are for public viewing and posted on practices regulation (21 CFR 10.115).
solely responsible for ensuring that your https://www.regulations.gov. Submit The guidance represents the current
comment does not include any both copies to the Division of Dockets thinking of FDA on ‘‘Question-Based
mstockstill on DSK3G9T082PROD with NOTICES
confidential information that you or a Management. If you do not wish your Review for the Chemistry,
third party may not wish to be posted, name and contact information to be Manufacturing, and Controls Technical
such as medical information, your or made publicly available, you can Section of Animal Drug Applications.’’
anyone else’s Social Security number, or provide this information on the cover It does not establish any rights for any
confidential business information, such sheet and not in the body of your person and is not binding on FDA or the
as a manufacturing process. Please note comments and you must identify this public. You can use an alternative
that if you include your name, contact information as ‘‘confidential.’’ Any approach if it satisfies the requirements
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![Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92835
of the applicable statutes and ADDRESSES: All submissions received Form Number: N/A.
regulations. must include the OMB Control Number Abstract: The Electronic Visa Update
1651–0139 in the subject line and the System (EVUS) provides a mechanism
III. Paperwork Reduction Act of 1995
agency name. To avoid duplicate through which visa information updates
This guidance refers to previously submissions, please use only one of the
approved collections of information can be obtained from certain
following methods to submit comments:
found in FDA regulations. These nonimmigrant aliens in advance of their
(1) Email. Submit comments to: (CBP_
collections of information are subject to PRA@cbp.dhs.gov). The email should travel to the United States. This
review by the Office of Management and include the OMB Control number in the provides CBP access to updated
Budget (OMB) under the Paperwork subject line. information without requiring aliens to
Reduction Act of 1995 (44 U.S.C. 3501– (2) Mail. Submit written comments to apply for a visa more frequently. The
3520). The collections of information in CBP PRA Officer, U.S. Customs and EVUS requirements apply to
21 CFR part 514 have been approved Border Protection, Office of Trade, nonimmigrant aliens who hold a
under OMB control number 0910–0032; Regulations and Rulings, Economic passport issued by an identified country
the collections of information in section Impact Analysis Branch, 10th Floor, 90 containing a U.S. nonimmigrant visa of
512(n)(1) of the FD&C Act (21 U.S.C. K St NE., Washington, DC 20229–1177. a designated category. EVUS enrollment
360b(n)(1)) have been approved under FOR FURTHER INFORMATION CONTACT: is currently limited to nonimmigrant
OMB control number 0910–0669. Requests for additional PRA information aliens who hold unrestricted, maximum
IV. Electronic Access should be directed to Paperwork validity B–1 (business visitor), B–2
Reduction Act Officer, U.S. Customs (visitor for pleasure), or combination B–
Persons with access to the Internet and Border Protection, Regulations and 1/B–2 visas, which are generally valid
may obtain the guidance at either http:// Rulings, Office of Trade, 90 K Street for 10 years, contained in a passport
www.fda.gov/AnimalVeterinary/ NE., 10th Floor, Washington, DC 20229– issued by the People’s Republic of
GuidanceComplianceEnforcement/ 1177, or via email (CBP_PRA@ China.
GuidanceforIndustry/default.htm or cbp.dhs.gov). Please note that the
https://www.regulations.gov. EVUS provides for greater efficiencies
contact information provided here is in the screening of international
Dated: December 15, 2016. solely for questions regarding this
travelers by allowing DHS to identify
Leslie Kux, notice. Individuals seeking information
nonimmigrant aliens who may be
Associate Commissioner for Policy. about other CBP programs should
contact the CBP National Customer inadmissible before they depart for the
[FR Doc. 2016–30613 Filed 12–19–16; 8:45 am] United States, thereby increasing
BILLING CODE 4164–01–P
Service Center at 877–227–5511, (TTY)
1–800–877–8339, or CBP Web site at security and reducing traveler delays
https://www.cbp.gov/. For additional upon arrival at U.S. ports of entry.
help: https://help.cbp.gov/app/home/ EVUS aids DHS in facilitating legitimate
DEPARTMENT OF HOMELAND travel while also enhancing public
SECURITY search/1.
SUPPLEMENTARY INFORMATION: CBP safety and national security.
U.S. Customs and Border Protection invites the general public and other Current Actions: This submission is
Federal agencies to comment on being made to extend the expiration
[1651–0139]
proposed and/or continuing information date. There are no changes to the
Agency Information Collection collections pursuant to the Paperwork information collected.
Activities: Electronic Visa Update Reduction Act of 1995 (44 U.S.C. 3507). Type of Review: Extension without
System The comments should address: (a) change to the burden hours.
Whether the collection of information is
AGENCY: U.S. Customs and Border necessary for the proper performance of Affected Public: Individuals.
Protection, Department of Homeland the functions of the agency, including Estimated Number of Respondents:
Security. whether the information shall have 3,595,904.
ACTION: 60-Day notice and request for practical utility; (b) the accuracy of the Estimated Number of Responses per
comments; extension of an existing agency’s estimates of the burden of the
Respondent: 1.
collection of information. collection of information; (c) ways to
enhance the quality, utility, and clarity Estimated Total Annual Responses:
SUMMARY: U.S. Customs and Border of the information to be collected; (d) 3,595,904.
Protection (CBP) of the Department of ways to minimize the burden including Estimated Time per Response: 25
Homeland Security will be submitting the use of automated collection minutes.
the following information collection techniques or the use of other forms of
request to the Office of Management and Estimated Total Annual Burden
information technology; and (e) the
Budget (OMB) for review and approval annual cost burden to respondents or Hours: 1,499,492.
in accordance with the Paperwork record keepers from the collection of Dated: December 14, 2016.
Reduction Act: Electronic Visa Update information (total capital/startup costs Seth Renkema,
System (EVUS). CBP is proposing that and operations and maintenance costs). Branch Chief, Economic Impact Analysis
this information collection be extended The comments that are submitted will Branch, U.S. Customs and Border Protection.
with no change to the burden hours or be summarized and included in the CBP
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–30527 Filed 12–19–16; 8:45 am]
to the information collected. This request for OMB approval. All
document is published to obtain BILLING CODE 9111–14–P
comments will become a matter of
comments from the public and affected public record. In this document, CBP is
agencies. soliciting comments concerning the
DATES: Written comments should be following Information collection:
received on or before February 21, 2017 Title: Electronic Visa Update System.
to be assured of consideration. OMB Number: 1651–0139.
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Document Created: 2018-02-14 09:09:54
Document Modified: 2018-02-14 09:09:54
| 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 | 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 92834 |
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