82 FR 34534 - Animal Drug User Fees and Fee Waivers and Reductions; Revised Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 141 (July 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 141 (July 25, 2017)
| Page Range | 34534-34535 | |
| FR Document | 2017-15536 |
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)] [Notices] [Pages 34534-34535] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15536] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-D-0369] Animal Drug User Fees and Fee Waivers and Reductions; 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 guidance for industry (GFI) #170 entitled ``Animal Drug User Fees and Fee Waivers and Reductions.'' This revised guidance document describes the types of fees that FDA is authorized to collect under the Animal Drug User Fee Act of 2003, as amended, and how to request waivers and reductions of these fees. 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-0369 for ``Animal Drug User Fees and Fee Waivers and Reductions.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments [[Page 34535]] 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 Dockets Management Staff, 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: Diane Heinz, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5692, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 2, 2016 (81 FR 76360), FDA published the notice of availability for a draft revised guidance entitled ``Animal Drug User Fees and Fee Waivers and Reductions'' giving interested persons until January 3, 2017, to comment on the draft revised guidance. FDA received no comments on the draft revised guidance. The guidance announced in this notice finalizes the draft guidance dated November 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 Animal Drug User Fees and Fee Waivers and Reductions. 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. This guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This 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 ``Animal Drug User Fees and Fee Waivers and Reductions'' have been approved under OMB control number 0910-540. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: July 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15536 Filed 7-24-17; 8:45 am] BILLING CODE 4164-01-P
![34534 Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
later than October 3, 2017. No Dated: July 18, 2017. manner detailed (see ‘‘Written/Paper
commercial or promotional material Anna K. Abram, Submissions’’ and ‘‘Instructions’’).
will be permitted to be presented or Deputy Commissioner for Policy, Planning, Written/Paper Submissions
distributed at the public workshop. Legislation, and Analysis.
Streaming webcast of the public [FR Doc. 2017–15542 Filed 7–24–17; 8:45 am] Submit written/paper submissions as
workshop: This public workshop will BILLING CODE 4164–01–P
follows:
• Mail/Hand delivery/Courier (for
also be webcast. The webcast link will
written/paper submissions): Dockets
be available on the registration Web
DEPARTMENT OF HEALTH AND Management Staff (HFA–305), Food and
page after October 3, 2017.
HUMAN SERVICES Drug Administration, 5630 Fishers
Organizations are requested to register
Lane, Rm. 1061, Rockville, MD 20852.
all participants, but to view using one • For written/paper comments
connection per location. Food and Drug Administration
submitted to the Dockets Management
If you have never attended a Connect [Docket No. FDA–2004–D–0369] Staff, FDA will post your comment, as
Pro event before, test your connection at well as any attachments, except for
https://collaboration.fda.gov/common/ Animal Drug User Fees and Fee
information submitted, marked and
help/en/support/meeting_test.htm. To Waivers and Reductions; Revised
identified, as confidential, if submitted
get a quick overview of the Connect Pro Guidance for Industry; Availability
as detailed in ‘‘Instructions.’’
program, visit https://www.adobe.com/ AGENCY: Food and Drug Administration, Instructions: All submissions received
go/connectpro_overview. FDA has HHS. must include the Docket No. FDA–
verified the Web site addresses in this ACTION: Notice of availability. 2004–D–0369 for ‘‘Animal Drug User
document, as of the date this document Fees and Fee Waivers and Reductions.’’
publishes in the Federal Register, but SUMMARY: The Food and Drug Received comments will be placed in
Web sites are subject to change over Administration (FDA or Agency) is the docket and, except for those
time. announcing the availability of a submitted as ‘‘Confidential
Transcripts: Please be advised that as guidance for industry (GFI) #170 Submissions,’’ publicly viewable at
soon as a transcript of the public entitled ‘‘Animal Drug User Fees and https://www.regulations.gov or at the
workshop is available, it will be Fee Waivers and Reductions.’’ This Dockets Management Staff between 9
accessible at https:// revised guidance document describes a.m. and 4 p.m., Monday through
www.regulations.gov. It may be viewed the types of fees that FDA is authorized Friday.
at the Dockets Management Staff (see to collect under the Animal Drug User • Confidential Submissions—To
ADDRESSES). A link to the transcript will Fee Act of 2003, as amended, and how submit a comment with confidential
also be available on the Internet at to request waivers and reductions of information that you do not wish to be
http://www.fda.gov/MedicalDevices/ these fees. made publicly available, submit your
NewsEvents/WorkshopsConferences/ DATES: Submit either electronic or comments only as a written/paper
default.htm. (Select this public written comments on Agency guidances submission. You should submit two
workshop from the posted events list.) at any time. copies total. One copy will include the
ADDRESSES: You may submit comments information you claim to be confidential
IV. References as follows: with a heading or cover note that states
The following references are on ‘‘THIS DOCUMENT CONTAINS
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
display in the Dockets Management
Staff (see ADDRESSES), and are available Submit electronic comments in the Agency will review this copy, including
for viewing by interested persons following way: the claimed confidential information, in
between 9 a.m. and 4 p.m., Monday • Federal eRulemaking Portal: its consideration of comments. The
through Friday; they are also available https://www.regulations.gov. Follow the second copy, which will have the
electronically at https:// instructions for submitting comments. claimed confidential information
www.regulations.gov. FDA has verified Comments submitted electronically, redacted/blacked out, will be available
the Web site addresses, as of the date including attachments, to https:// for public viewing and posted on
this document publishes in the Federal www.regulations.gov will be posted to https://www.regulations.gov. Submit
Register, but Web sites are subject to the docket unchanged. Because your both copies to the Dockets Management
change over time. comment will be made public, you are Staff. If you do not wish your name and
solely responsible for ensuring that your contact information to be made publicly
1. FDA’s CDRH Case for Quality Initiative comment does not include any available, you can provide this
is available at: https://www.fda.gov/ confidential information that you or a information on the cover sheet and not
MedicalDevices/DeviceRegulationand
Guidance/MedicalDeviceQualityand
third party may not wish to be posted, in the body of your comments and you
Compliance/ucm378185.htm. such as medical information, your or must identify this information as
2. CDRH, 2016–2017 ‘‘Promote a Culture of anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
Quality and Organizational Excellence’’ confidential business information, such as ‘‘confidential’’ will not be disclosed
available at: https://www.fda.gov/downloads/ as a manufacturing process. Please note except in accordance with 21 CFR 10.20
AboutFDA/CentersOffices/OfficeofMedical that if you include your name, contact and other applicable disclosure law. For
ProductsandTobacco/CDRH/CDRHVisionand information, or other information that more information about FDA’s posting
Mission/UCM481588.pdf. identifies you in the body of your of comments to public dockets, see 80
mstockstill on DSK30JT082PROD with NOTICES
3. The Quality System regulation available comments, that information will be FR 56469, September 18, 2015, or access
at: https://www.ecfr.gov/cgi-bin/text-idx?
SID=54a4a38f9c25eeab900b1c8f6c
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
0f4212&mc
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
=true&node=pt21.8.820&rgn=div5. with confidential information that you 23389.pdf.
4. MDIC available at: http://mdic.org/. do not wish to be made available to the Docket: For access to the docket to
5. CMMI system available at: http:// public, submit the comment as a read background documents or the
cmmiinstitute.com/. written/paper submission and in the electronic and written/paper comments
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![Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices 34535
received, go to https:// IV. Electronic Access instructions for submitting comments.
www.regulations.gov/ and insert the Persons with access to the Internet Comments submitted electronically,
docket number, found in brackets in the may obtain the guidance at either including attachments, to https://
heading of this document, into the https://www.fda.gov/AnimalVeterinary/ www.regulations.gov will be posted to
‘‘Search’’ box and follow the prompts GuidanceComplianceEnforcement/ the docket unchanged. Because your
and/or go to the Dockets Management GuidanceforIndustry/default.htm or comment will be made public, you are
Staff, 5630 Fishers Lane, Rm. 1061, https://www.regulations.gov. solely responsible for ensuring that your
Rockville, MD 20852. comment does not include any
Submit written requests for single Dated: July 19, 2017. confidential information that you or a
copies of the guidance to the Policy and Anna K. Abram, third party may not wish to be posted,
Regulations Staff (HFV–6), Center for Deputy Commissioner for Policy, Planning, such as medical information, your or
Veterinary Medicine, Food and Drug Legislation, and Analysis. anyone else’s Social Security number, or
Administration, 7519 Standish Pl., [FR Doc. 2017–15536 Filed 7–24–17; 8:45 am] confidential business information, such
Rockville, MD 20855. Send one self- BILLING CODE 4164–01–P as a manufacturing process. Please note
addressed adhesive label to assist that that if you include your name, contact
office in processing your requests. See information, or other information that
the SUPPLEMENTARY INFORMATION section DEPARTMENT OF HEALTH AND identifies you in the body of your
for electronic access to the guidance HUMAN SERVICES comments, that information will be
document. posted on https://www.regulations.gov.
Food and Drug Administration • If you want to submit a comment
FOR FURTHER INFORMATION CONTACT: with confidential information that you
[Docket No. FDA–2017–D–3235]
Diane Heinz, Center for Veterinary do not wish to be made available to the
Medicine (HFV–6), Food and Drug Institutional Review Board Waiver or public, submit the comment as a
Administration, 7519 Standish Pl., Alteration of Informed Consent for written/paper submission and in the
Rockville, MD 20855, 240–402–5692, Clinical Investigations Involving No manner detailed (see ‘‘Written/Paper
diane.heinz@fda.hhs.gov. More Than Minimal Risk to Human Submissions’’ and ‘‘Instructions’’).
SUPPLEMENTARY INFORMATION: Subjects; Guidance for Sponsors,
Written/Paper Submissions
I. Background Investigators, and Institutional Review
Boards; Availability Submit written/paper submissions as
In the Federal Register of November follows:
2, 2016 (81 FR 76360), FDA published AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
the notice of availability for a draft HHS. written/paper submissions): Dockets
revised guidance entitled ‘‘Animal Drug ACTION: Notice of availability. Management Staff (HFA–305), Food and
User Fees and Fee Waivers and Drug Administration, 5630 Fishers
Reductions’’ giving interested persons SUMMARY: The Food and Drug Lane, rm. 1061, Rockville, MD 20852.
until January 3, 2017, to comment on Administration (FDA, the Agency, or • For written/paper comments
the draft revised guidance. FDA we) is announcing the availability of a submitted to the Dockets Management
received no comments on the draft guidance for sponsors, investigators, Staff, FDA will post your comment, as
revised guidance. The guidance and institutional review boards (IRBs) well as any attachments, except for
announced in this notice finalizes the entitled ‘‘IRB Waiver or Alteration of information submitted, marked and
draft guidance dated November 2016. Informed Consent for Clinical identified, as confidential, if submitted
Investigations Involving No More Than as detailed in ‘‘Instructions.’’
II. Significance of Guidance Minimal Risk to Human Subjects.’’ This Instructions: All submissions received
This level 1 guidance is being issued guidance informs sponsors, must include the Docket No. FDA–
consistent with FDA’s good guidance investigators, IRBs, and other interested 2017–D–3235 for ‘‘IRB Waiver or
practices regulation (21 CFR 10.115). parties that FDA does not intend to Alteration of Informed Consent for
The guidance represents the current object to an IRB waiving or altering Clinical Investigations Involving No
thinking of FDA on Animal Drug User informed consent requirements, as More Than Minimal Risk to Human
Fees and Fee Waivers and Reductions. described in the guidance, for certain Subjects; Guidance for Sponsors,
It does not establish any rights for any minimal risk clinical investigations. In Investigators, and Institutional Review
person and is not binding on FDA or the addition, this guidance explains that Boards.’’ Received comments will be
public. You can use an alternative FDA does not intend to object to a placed in the docket and, except for
approach if it satisfies the requirements sponsor initiating, or an investigator those submitted as ‘‘Confidential
of the applicable statutes and conducting, a minimal risk clinical Submissions,’’ publicly viewable at
regulations. This guidance is not subject investigation for which an IRB waives or https://www.regulations.gov or at the
to Executive Order 12866. alters the informed consent office of Dockets Management Staff
requirements as described in the between 9 a.m. and 4 p.m., Monday
III. Paperwork Reduction Act of 1995 guidance. through Friday.
This revised guidance refers to DATES: Submit either electronic or • Confidential Submissions—To
previously approved collections of written comments on Agency guidances submit a comment with confidential
information that are subject to review by at any time. information that you do not wish to be
the Office of Management and Budget made publicly available, submit your
mstockstill on DSK30JT082PROD with NOTICES
ADDRESSES: You may submit comments
(OMB) under the Paperwork Reduction as follows: comments only as a written/paper
Act of 1995 (44 U.S.C. 3501–3520). The submission. You should submit two
collections of information referred to in Electronic Submissions copies total. One copy will include the
the guidance entitled ‘‘Animal Drug Submit electronic comments in the information you claim to be confidential
User Fees and Fee Waivers and following way: with a heading or cover note that states
Reductions’’ have been approved under • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
OMB control number 0910–540. https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
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Document Created: 2018-10-24 11:20:47
Document Modified: 2018-10-24 11:20:47
| 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 | Diane Heinz, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5692, [email protected] | |
| FR Citation | 82 FR 34534 |
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