81 FR 23305 - Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 76 (April 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23305-23306 | |
| FR Document | 2016-09151 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23305-23306] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09151] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for notification of participation. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders--including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts--in developing recommendations for the next ADUFA program, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation. DATES: Submit notification of intention to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization by May 16, 2016. These stakeholder meetings are expected to commence in September/October 2016 and will continue at least once every 4 months during reauthorization negotiations with the regulated industry. See the SUPPLEMENTARY INFORMATION section for further information regarding notification of intention to participate. ADDRESSES: The stakeholder meetings will be held at the Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855. FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary Medicine, Food and Drug Administration,7519 Standish Pl., Rockville, MD 20855, 240-402-6866, FAX: 240-276-9744, [email protected]. SUPPLEMENTARY INFORMATION: I. Introduction In 2013 Congress passed the Animal Drug User Fee Amendments of 2013 (Pub. L. 113-14; ADUFA III). The authority for ADUFA III expires September 30, 2018. Without new legislation to reauthorize the program, FDA will no longer be able to collect user fees for future fiscal years to fund the animal drug review process. Section 740A(d)(1) of the FD&C Act (21 U.S.C. 379j-13(d)(1)) requires that FDA consult with a range of stakeholders in developing recommendations for consideration for the next ADUFA program, including representatives from [[Page 23306]] patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts. To initiate this process of consultation, elsewhere in this issue of the Federal Register, we are announcing a public meeting to be held on May 16, 2016, where stakeholders and other members of the public will be given an opportunity to present their views on the reauthorization. The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. Section 740A(d)(3) of the FD&C Act further requires that FDA continue meeting with these stakeholders at least once every 4 months during negotiations with the regulated industry to continue discussions of their views on the reauthorization, including suggested changes to the ADUFA program. FDA is issuing this Federal Register notice to request that stakeholders--including veterinary, patient and consumer groups, as well as scientific and academic experts--notify FDA of their intent to participate in the periodic consultation meetings on ADUFA reauthorization. FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions. If you wish to participate in this part of the reauthorization process, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions. Stakeholders who identify themselves through this notice will be included in all future stakeholder discussion while FDA negotiates with the regulated industry. If a stakeholder decides to participate in these meetings at a later time, they may still participate in remaining meetings by notifying FDA (see ADDRESSES). These stakeholder discussions will satisfy the requirement in section 740A(d)(3) of the FD&C Act. II. Notification of Intent To Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization, please submit notification by email to [email protected] by May 16, 2016. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, telephone number, and notice of any special accommodations required due to a disability. Stakeholders will receive confirmation and additional information about the first meeting after FDA receives this notification. Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09151 Filed 4-19-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23305
DATES: Submit notification of intention including veterinary, patient and SUMMARY: The Food and Drug
to participate in continued periodic consumer groups, as well as scientific Administration (FDA or Agency) is
stakeholder consultation meetings and academic experts—notify FDA of issuing this notice to request that public
regarding AGDUFA reauthorization by their intent to participate in the periodic stakeholders notify FDA of their intent
May 16, 2016. These stakeholder consultation meetings on AGDUFA to participate in periodic consultation
meetings are expected to commence in reauthorization. FDA believes that meetings on reauthorization of the
June/July 2016 and will continue at consistent stakeholder representation at Animal Drug User Fee Act (ADUFA).
least once every 4 months during these meetings will be important to The statutory authority for ADUFA
reauthorization negotiations with the ensure progress in these discussions. If expires September 30, 2018. The
regulated industry. See the you wish to participate in this part of Federal Food, Drug, and Cosmetic Act
SUPPLEMENTARY INFORMATION section for the reauthorization process, please (the FD&C Act) requires that FDA
further information regarding designate one or more representatives consult with a range of stakeholders—
notification of intention to participate. from your organization who will including patient and consumer
ADDRESSES: The stakeholder meetings commit to attending these meetings and advocacy groups, veterinary
will be held at the Food and Drug preparing for the discussions. professionals, and scientific and
Administration, Center for Veterinary Stakeholders who identify themselves academic experts—in developing
Medicine, 7519 Standish Pl., Rockville, through this notice will be included in recommendations for the next ADUFA
MD 20855. all future stakeholder discussion while program, and hold discussions with
FOR FURTHER INFORMATION CONTACT: FDA negotiates with the regulated these stakeholders at least once every 4
Cassie Ravo, Center for Veterinary industry. If a stakeholder decides to months during FDA’s negotiations with
Medicine, Food and Drug participate in these meetings at a later the regulated industry. The purpose of
Administration, 7519 Standish Pl., time, they may still participate in this request for notification is to ensure
Rockville, MD 20855, 240–402–6866, remaining meetings by notifying FDA continuity and progress in these regular
FAX: 240–276–9744, Cassie.Ravo@ (see ADDRESSES). These stakeholder discussions by establishing consistent
fda.hhs.gov. discussions will satisfy the requirement stakeholder representation.
in section 742(d)(3) of the FD&C Act. DATES: Submit notification of intention
SUPPLEMENTARY INFORMATION:
II. Notification of Intent To Participate to participate in continued periodic
I. Introduction in Periodic Stakeholder Consultation stakeholder consultation meetings
In 2013 Congress passed the Animal Meetings regarding ADUFA reauthorization by
Generic Drug User Fee Amendments of May 16, 2016. These stakeholder
If you intend to participate in meetings are expected to commence in
2013 (Pub. L. 113–14; AGDUFA II). The continued periodic stakeholder
authority for AGDUFA II expires September/October 2016 and will
consultation meetings regarding continue at least once every 4 months
September 30, 2018. Without new AGDUFA reauthorization, please submit
legislation to reauthorize the program, during reauthorization negotiations with
notification by email to: cvmagdufa@ the regulated industry. See the
FDA will no longer be able to collect fda.hhs.gov by May 16, 2016. Your SUPPLEMENTARY INFORMATION section for
user fees for future fiscal years to fund email should contain complete contact
the generic new animal drug review further information regarding
information for each attendee, including notification of intention to participate.
process. Section 742(d)(1) of the FD&C name, title, affiliation, address, email
Act (21 U.S.C. 379j–22(d)(1)) requires ADDRESSES: The stakeholder meetings
address, telephone number, and notice will be held at the Food and Drug
that FDA consult with a range of of any special accommodations required
stakeholders in developing Administration, Center for Veterinary
due to a disability. Stakeholders will Medicine, 7519 Standish Pl., Rockville,
recommendations for consideration for receive confirmation and additional
the next AGDUFA program, including MD 20855.
information about the first meeting after
representatives from patient and FOR FURTHER INFORMATION CONTACT:
FDA receives this notification.
consumer advocacy groups, veterinary Cassie Ravo, Center for Veterinary
professionals, and scientific and Dated: April 12, 2016. Medicine, Food and Drug
academic experts. To initiate this Leslie Kux, Administration,7519 Standish Pl.,
process of consultation, elsewhere in Associate Commissioner for Policy. Rockville, MD 20855, 240–402–6866,
this issue of the Federal Register, we are [FR Doc. 2016–09152 Filed 4–19–16; 8:45 am] FAX: 240–276–9744, Cassie.Ravo@
announcing a public meeting to be held BILLING CODE 4164–01–P fda.hhs.gov.
on May 16, 2016, where stakeholders SUPPLEMENTARY INFORMATION:
and other members of the public will be
given an opportunity to present their DEPARTMENT OF HEALTH AND I. Introduction
views on the reauthorization. The HUMAN SERVICES In 2013 Congress passed the Animal
meeting and written comments Drug User Fee Amendments of 2013
submitted to the docket will provide Food and Drug Administration (Pub. L. 113–14; ADUFA III). The
critical input as the Agency prepares for [Docket No. FDA–2011–N–0656] authority for ADUFA III expires
reauthorization discussions. Section September 30, 2018. Without new
742(d)(3) of the FD&C Act further Animal Drug User Fee Act; Stakeholder legislation to reauthorize the program,
requires that FDA continue meeting Consultation Meetings on the Animal FDA will no longer be able to collect
with these stakeholders at least once Drug User Fee Act Reauthorization; user fees for future fiscal years to fund
Lhorne on DSK5TPTVN1PROD with NOTICES
every 4 months during negotiations with Request for Notification of Stakeholder the animal drug review process. Section
the regulated industry to continue Intention To Participate 740A(d)(1) of the FD&C Act (21 U.S.C.
discussions of their views on the AGENCY: Food and Drug Administration, 379j–13(d)(1)) requires that FDA consult
reauthorization, including suggested HHS. with a range of stakeholders in
changes to the AGDUFA program. developing recommendations for
ACTION: Notice; request for notification
FDA is issuing this Federal Register consideration for the next ADUFA
of participation.
notice to request that stakeholders— program, including representatives from
VerDate Sep<11>2014 14:53 Apr 19, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1](https://thefederalregister.org/doc/81_FR_23381/page/1.svg)
![23306 Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
patient and consumer advocacy groups, Dated: April 12, 2016. information, or other information that
veterinary professionals, and scientific Leslie Kux, identifies you in the body of your
and academic experts. To initiate this Associate Commissioner for Policy. comments, that information will be
process of consultation, elsewhere in [FR Doc. 2016–09151 Filed 4–19–16; 8:45 am] posted on http://www.regulations.gov.
this issue of the Federal Register, we are BILLING CODE 4164–01–P
• If you want to submit a comment
announcing a public meeting to be held with confidential information that you
on May 16, 2016, where stakeholders do not wish to be made available to the
and other members of the public will be DEPARTMENT OF HEALTH AND public, submit the comment as a
given an opportunity to present their HUMAN SERVICES written/paper submission and in the
views on the reauthorization. The manner detailed (see ‘‘Written/Paper
meeting and written comments Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
submitted to the docket will provide [Docket No. FDA–2015–D–0230] Written/Paper Submissions
critical input as the Agency prepares for
reauthorization discussions. Section Technical Performance Assessment of Submit written/paper submissions as
740A(d)(3) of the FD&C Act further Digital Pathology Whole Slide Imaging follows:
requires that FDA continue meeting • Mail/Hand delivery/Courier (for
Devices; Guidance for Industry and
with these stakeholders at least once written/paper submissions): Division of
Food and Drug Administration Staff;
every 4 months during negotiations with Dockets Management (HFA–305), Food
Availability
the regulated industry to continue and Drug Administration, 5630 Fishers
discussions of their views on the AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
reauthorization, including suggested HHS. • For written/paper comments
changes to the ADUFA program. ACTION: Notice of availability. submitted to the Division of Dockets
FDA is issuing this Federal Register Management, FDA will post your
notice to request that stakeholders— SUMMARY: The Food and Drug comment, as well as any attachments,
including veterinary, patient and Administration (FDA or Agency) is except for information submitted,
consumer groups, as well as scientific announcing the availability of a marked and identified, as confidential,
and academic experts—notify FDA of guidance entitled ‘‘Technical if submitted as detailed in
their intent to participate in the periodic Performance Assessment of Digital ‘‘Instructions.’’
consultation meetings on ADUFA Pathology Whole Slide Imaging Instructions: All submissions received
reauthorization. FDA believes that Devices.’’ This guidance provides must include the Docket No. FDA–
consistent stakeholder representation at industry and Agency staff with 2015–D–0230 for ‘‘Technical
these meetings will be important to recommendations regarding the Performance Assessment of Digital
ensure progress in these discussions. If technical performance assessment data Pathology Whole Slide Imaging Devices;
you wish to participate in this part of for the evaluation of a digital whole Guidance for Industry and Food and
the reauthorization process, please slide imaging (WSI) system. The Drug Administration Staff.’’ Received
designate one or more representatives guidance provides suggestions on how comments will be placed in the docket
from your organization who will to best characterize the technical aspects and, except for those submitted as
commit to attending these meetings and that are relevant to WSI performance for ‘‘Confidential Submissions,’’ publicly
preparing for the discussions. their intended use and determine any viewable at http://www.regulations.gov
Stakeholders who identify themselves possible limitations that might affect or at the Division of Dockets
through this notice will be included in their safety and effectiveness. Management between 9 a.m. and 4 p.m.,
all future stakeholder discussion while DATES: Submit either electronic or Monday through Friday.
FDA negotiates with the regulated written comments on this guidance at • Confidential Submissions—To
industry. If a stakeholder decides to any time. General comments on Agency submit a comment with confidential
participate in these meetings at a later guidance documents are welcome at any information that you do not wish to be
time, they may still participate in time. made publicly available, submit your
remaining meetings by notifying FDA ADDRESSES: You may submit comments comments only as a written/paper
(see ADDRESSES). These stakeholder as follows: submission. You should submit two
discussions will satisfy the requirement copies total. One copy will include the
Electronic Submissions information you claim to be confidential
in section 740A(d)(3) of the FD&C Act.
Submit electronic comments in the with a heading or cover note that states
II. Notification of Intent To Participate following way: ‘‘THIS DOCUMENT CONTAINS
in Periodic Stakeholder Consultation • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
Meetings www.regulations.gov. Follow the Agency will review this copy, including
If you intend to participate in instructions for submitting comments. the claimed confidential information, in
continued periodic stakeholder Comments submitted electronically, its consideration of comments. The
consultation meetings regarding ADUFA including attachments, to http:// second copy, which will have the
reauthorization, please submit www.regulations.gov will be posted to claimed confidential information
notification by email to cvmadufa@ the docket unchanged. Because your redacted/blacked out, will be available
fda.hhs.gov by May 16, 2016. Your comment will be made public, you are for public viewing and posted on http://
email should contain complete contact solely responsible for ensuring that your www.regulations.gov. Submit both
information for each attendee, including comment does not include any copies to the Division of Dockets
Lhorne on DSK5TPTVN1PROD with NOTICES
name, title, affiliation, address, email confidential information that you or a Management. If you do not wish your
address, telephone number, and notice third party may not wish to be posted, name and contact information to be
of any special accommodations required such as medical information, your or made publicly available, you can
due to a disability. Stakeholders will anyone else’s Social Security number, or provide this information on the cover
receive confirmation and additional confidential business information, such sheet and not in the body of your
information about the first meeting after as a manufacturing process. Please note comments and you must identify this
FDA receives this notification. that if you include your name, contact information as ‘‘confidential.’’ Any
VerDate Sep<11>2014 14:53 Apr 19, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1](https://thefederalregister.org/doc/81_FR_23381/page/2.svg)
Document Created: 2016-04-20 01:51:35
Document Modified: 2016-04-20 01:51:35
| 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; request for notification of participation. | |
| Dates | Submit notification of intention to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization by May 16, 2016. These stakeholder meetings are expected to commence in September/October 2016 and will continue at least once every 4 months during reauthorization negotiations with the regulated industry. See the SUPPLEMENTARY INFORMATION section for further information regarding notification of intention to participate. | |
| Contact | Cassie Ravo, Center for Veterinary Medicine, Food and Drug Administration,7519 Standish Pl., Rockville, MD 20855, 240-402-6866, FAX: 240-276-9744, [email protected] | |
| FR Citation | 81 FR 23305 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR