82 FR 46503 - Animal Drug User Fee Act; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 192 (October 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 192 (October 5, 2017)
| Page Range | 46503-46505 | |
| FR Document | 2017-21439 |
[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)] [Notices] [Pages 46503-46505] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21439] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing a forthcoming public meeting entitled ``Animal Drug User Fee Act.'' The topic to be discussed is proposed recommendations for the reauthorization of the Animal Drug User Fee Act (ADUFA IV). The meeting will be open to the public. DATES: The public meeting will be held on November 2, 2017, from 9 a.m. to 12 noon. Submit either electronic or written comments on this public meeting to the docket by November 17, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at 7500 Standish Pl., Room N149 (first floor), Rockville, MD 20855. Free parking is available onsite. Attendees must provide a valid government issued photo ID (driver's license, identification card, or passport) to enter the facility. Entrance for the public meeting participants (non-FDA employees) is through the front of the building where routine security check procedures will be performed. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Comments must be submitted on or before November 17, 2017.\1\ The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 17, 2017. Comments received by mail/hand delivery/ courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. --------------------------------------------------------------------------- \1\ This date corrects the comment closing date of December 1, 2017, stated in the Federal Register notice announcing the initial ADUFA reauthorization public meeting held on May 16, 2016 (81 FR 23313, April 20, 2016). --------------------------------------------------------------------------- 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 [[Page 46504]] 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-2011-N-0656 for ``Animal Drug User Fee Act; Public Meeting; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), 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 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. In addition to being publicly viewable at https://www.regulations.gov, comments will also be published on https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-6866, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of ADUFA, which authorizes FDA to collect user fees and use them for the process of reviewing new animal drug applications and associated submissions. The authority for ADUFA expires September 30, 2018. Without new legislation, FDA will no longer have the authority to collect user fees to fund the new animal drug review process for future fiscal years. Section 740A(d)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j- 13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholder, and before transmitting the Agency's final recommendation to Congress for the reauthorized program (ADUFA IV), we do the following: (1) Present the recommendation to the relevant Congressional committees, (2) publish such recommendations in the Federal Register, (3) provide for a period of 30 days for the public to provide written comments on such recommendations, (4) hold a meeting at which the public may present its views on such recommendations, and (5) consider such public views and comments and revise such recommendations as necessary. This notice, the 30-day comment period, and the public meeting will satisfy certain of these requirements. After the public meeting, we will revise the draft recommendations as necessary. In addition, the Agency will present the draft recommendations to the Congressional committees. FDA considers the timely review of the safety and effectiveness of new animal drug applications (NADAs) to be central to the Agency's mission to protect and promote human and animal health. Prior to 2004, the timeliness and predictability of the new animal drug review program was a concern. The Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-130; hereinafter referred to as ``ADUFA I'') authorized FDA to collect user fees dedicated to the timely review of new animal drug applications in accordance with certain performance goals and to expand and modernize the new animal drug review program. The Agency agreed, under ADUFA I, to meet a comprehensive set of performance goals established to show significant improvement in the timeliness and predictability of the new animal drug review process. The implementation of ADUFA I provided a significant funding increase that enabled FDA to increase the number of staff dedicated to the new animal drug application review process by 30 percent in ADUFA I. In 2008, before ADUFA I expired, Congress passed the Animal Drug User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to as ``ADUFA II'') which included an extension of ADUFA for an additional 5 years (fiscal year (FY) 2009 through FY 2013). ADUFA II performance goals were established based on ADUFA I FY 2008 review time frames. In addition, FDA provided program enhancements to reduce review cycles and improve communications during reviews. The ADUFA programs have enabled FDA to meet performance timeframes for application review for new animal drugs without compromising the quality of the Agency's review. In 2013, Congress passed the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013, reauthorizing ADUFA (Pub. L. 113- 14; hereinafter referred to as ``ADUFA III''). ADUFA II was set to expire September 30, 2013, and the new reauthorization extends ADUFA until 2018. ADUFA III reauthorization maintained the FY 2013 review timeframes for key submissions in addition to enhancements to the program. Enhancements included: Replacing the End Review Amendment with a short, second-round review; reducing time for microbial food safety hazard characterization submissions to [[Page 46505]] 100 days; and adding a variable inflation adjuster to account for changes in the Center for Veterinary Medicine's costs using the Consumer Price Index as a guide. Also, the proportion of revenue collected from fees was redistributed as follows: Application fees from 25 percent to 20 percent; product fees from 25 percent to 27 percent; establishment fees from 25 percent to 26 percent; and sponsor fees from 25 percent to 27 percent. Additionally, there were chemistry, manufacturing, and controls (CMC) enhancements, including: Permitting the manufacturing supplements to be resubmitted as ``Supplement-Changes Being Effected in 30 Days'' if deficiencies are not substantial for manufacturing supplements requiring prior approval according to 21 CFR 514.8(b); permitting comparability protocols as described in 21 CFR 514.8(b)(2)(v) to be submitted as protocols without substantial data in an investigational new animal drug (INAD) file; and developing guidance for a two-phased CMC technical section submission and review process under the INAD file. The Agency agreed to explore the feasibility of pursuing expanded conditional approvals and of modifying the current requirement that the use of multiple new animal drugs in the same medicated feed (combination medicated feed) be subject to an approved application. The reauthorization of ADUFA is targeted to generate $114,000,000 in user fees over 5 years (FY 2014 through FY 2018). FDA has published a number of reports that provide useful background on ADUFA I, II, and III. ADUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports can be found at: https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm. II. Topics for Discussion at the Public Meeting In preparing the proposed recommendations to Congress for ADUFA reauthorization (ADUFA IV), we have conducted discussions with the regulated industry, and we have consulted with stakeholders as required by the law. We began the ADUFA reauthorization process with a public meeting held on May 16, 2016 (81 FR 23313, April 20, 2016). Following the May 2016 public meeting, FDA conducted negotiations with regulated industry and continued regular consultations with public stakeholders from October 2016 through April 2017. As directed by Congress, FDA posted minutes of these discussions on its Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. The proposed enhancements from ADUFA IV address many of the top priorities identified by public stakeholders, the top concerns identified by regulated industry, and the most important challenges identified within FDA. The full descriptions of these proposed recommendations can be found in the proposed ADUFA IV Performance Goals and Procedures Letter. FDA intends to publish in the Federal Register the full text of the proposed ADUFA IV Performance Goals and Procedures Letter and a summary of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm before the public meeting and will provide for a period of 30 days for the public to provide written comments. FDA will post the agenda approximately 5 days before the meeting at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm. III. Participating in the Public Meeting Registration: To register for the public meeting, please contact Cassie Ravo (see FOR FURTHER INFORMATION CONTACT). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Also, please self-identify as a member of one of the following stakeholder categories: Scientific or academic experts; veterinary professionals; patients and consumer advocacy groups; or the regulated industry, and whether you are requesting a scheduled presentation. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by October 26, 2017, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8:30 a.m. We will let registrants know if registration closes before the day of the public meeting. If you need special accommodations due to a disability, please contact Cassie Ravo (see FOR FURTHER INFORMATION CONTACT) no later than October 26, 2017. Requests for Oral Presentations: When registering, you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by October 27, 2017. All requests to make oral presentations must be received by the close of registration on October 26, 2017. If selected for presentation, any presentation materials must be emailed to the Cassie Ravo (see FOR FURTHER INFORMATION CONTACT) no later than October 31, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Streaming Webcast of the public meeting: This public meeting will also be webcast. Event: ADUFA IV Public Meeting. Event address for attendees: https://fda.webex.com/fda/onstage/g.php?MTID=e9adcd215b7dba5d99361b002663e51fe. Date and time: Thursday, November 2, 2017, 9 a.m. Eastern Daylight Time (New York, GMT-4). Duration: 3 hours. Event number: 812 395 634. Event password: 110217. Teleconference: Provide your number when you join the event to receive a call back. (1) Call one of the following numbers: Local: 1-301-796- 7777; toll free: 1-855-828-1770. (2) Follow the instructions that you hear on the phone. Cisco Unified MeetingPlace meeting ID: 812 395 634. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at: https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. Dated: September 29, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21439 Filed 10-4-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46503
permission to market the drug product. This determination of the regulatory meeting entitled ‘‘Animal Drug User Fee
Although only a portion of a regulatory review period establishes the maximum Act.’’ The topic to be discussed is
review period may count toward the potential length of a patent extension. proposed recommendations for the
actual amount of extension that the However, the USPTO applies several reauthorization of the Animal Drug User
Director of USPTO may award (for statutory limitations in its calculations Fee Act (ADUFA IV). The meeting will
example, half the testing phase must be of the actual period for patent extension. be open to the public.
subtracted as well as any time that may In its applications for patent extension, DATES: The public meeting will be held
have occurred before the patent was this applicant seeks 1,438 days, 1,144 on November 2, 2017, from 9 a.m. to 12
issued), FDA’s determination of the days, 811 days, or 654 days of patent noon. Submit either electronic or
length of a regulatory review period for term extension. written comments on this public
a human drug product will include all III. Petitions meeting to the docket by November 17,
of the testing phase and approval phase 2017. See the SUPPLEMENTARY
as specified in 35 U.S.C. 156(g)(1)(B). Anyone with knowledge that any of INFORMATION section for registration date
FDA has approved for marketing the the dates as published are incorrect may
and information.
human drug product TECFIDERA submit either electronic or written
ADDRESSES: The public meeting will be
(dimethyl fumarate). TECFIDERA is comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES). held at 7500 Standish Pl., Room N149
indicated for treatment of patients with (first floor), Rockville, MD 20855. Free
relapsing forms of multiple sclerosis. Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may parking is available onsite. Attendees
Subsequent to this approval, the USPTO must provide a valid government issued
received patent term restoration petition FDA for a determination
regarding whether the applicant for photo ID (driver’s license, identification
applications for TECFIDERA (U.S. card, or passport) to enter the facility.
Patent Nos. 6,509,376; 7,320,999; extension acted with due diligence
during the regulatory review period. To Entrance for the public meeting
7,619,001; and 7,803,840) from Biogen participants (non-FDA employees) is
Idec International GmbH, and the meet its burden, the petition must
comply with all the requirements of through the front of the building where
USPTO requested FDA’s assistance in routine security check procedures will
determining the patents’ eligibility for § 60.30, including but not limited to:
Must be timely (see DATES), must be be performed.
patent term restoration. In a letter dated You may submit comments as
November 4, 2015, FDA advised the filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA follows. Please note that late, untimely
USPTO that this human drug product filed comments will not be considered.
had undergone a regulatory review investigation, and must certify that a
true and complete copy of the petition Comments must be submitted on or
period and that the approval of before November 17, 2017.1 The https://
TECFIDERA represented the first has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th www.regulations.gov electronic filing
permitted commercial marketing or use system will accept comments until
of the product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format midnight Eastern Time at the end of
requested that FDA determine the November 17, 2017. Comments received
product’s regulatory review period. specified in 21 CFR 10.30.
Submit petitions electronically to by mail/hand delivery/courier (for
II. Determination of Regulatory Review https://www.regulations.gov at Docket written/paper submissions) will be
Period No. FDA–2013–S–0610. Submit written considered timely if they are
petitions (two copies are required) to the postmarked or the delivery service
FDA has determined that the acceptance receipt is on or before that
applicable regulatory review period for Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630 date.
TECFIDERA is 2,480 days. Of this time,
2,085 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD Electronic Submissions
phase and 395 days occurred during the 20852.
Submit electronic comments in the
approval phase. These periods of time Dated: September 29, 2017. following way:
were derived from the following dates: Anna K. Abram, • Federal eRulemaking Portal:
1. The date an exemption under Deputy Commissioner for Policy, Planning, https://www.regulations.gov. Follow the
section 505(i) of the Federal Food, Drug, Legislation, and Analysis. instructions for submitting comments.
and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2017–21435 Filed 10–4–17; 8:45 am] Comments submitted electronically,
U.S.C. 355(i)) became effective: June 14, BILLING CODE 4164–01–P including attachments, to https://
2006. FDA has verified the applicant’s www.regulations.gov will be posted to
claim that the date the investigational the docket unchanged. Because your
new drug application (IND) became DEPARTMENT OF HEALTH AND comment will be made public, you are
effective was on June 14, 2006. HUMAN SERVICES solely responsible for ensuring that your
2. The date the application was comment does not include any
initially submitted with respect to the Food and Drug Administration confidential information that you or a
human drug product under section [Docket No. FDA–2011–N–0656] third party may not wish to be posted,
505(b) of the FD&C Act: February 27, such as medical information, your or
2012. FDA has verified the applicant’s Animal Drug User Fee Act; Public anyone else’s Social Security number, or
claim that the new drug application Meeting; Request for Comments confidential business information, such
(NDA) for TECFIDERA (NDA 204063) AGENCY: Food and Drug Administration, as a manufacturing process. Please note
ethrower on DSK3G9T082PROD with NOTICES
was initially submitted on February 27, HHS. that if you include your name, contact
2012. information, or other information that
ACTION: Notice of public meeting;
3. The date the application was request for comments. 1 This date corrects the comment closing date of
approved: March 27, 2013. FDA has
December 1, 2017, stated in the Federal Register
verified the applicant’s claims that NDA SUMMARY: The Food and Drug notice announcing the initial ADUFA
204063 was approved on March 27, Administration (FDA, the Agency, or reauthorization public meeting held on May 16,
2013. we) is announcing a forthcoming public 2016 (81 FR 23313, April 20, 2016).
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![Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46505
100 days; and adding a variable site at https://www.fda.gov/ForIndustry/ comment session or participate in a
inflation adjuster to account for changes UserFees/AnimalDrugUserFee specific session, and which topic(s) you
in the Center for Veterinary Medicine’s ActADUFA/ucm042891.htm. wish to address. We will do our best to
costs using the Consumer Price Index as The proposed enhancements from accommodate requests to make public
a guide. Also, the proportion of revenue ADUFA IV address many of the top comments. Individuals and
collected from fees was redistributed as priorities identified by public organizations with common interests are
follows: Application fees from 25 stakeholders, the top concerns urged to consolidate or coordinate their
percent to 20 percent; product fees from identified by regulated industry, and the presentations, and request time for a
25 percent to 27 percent; establishment most important challenges identified joint presentation, or submit requests for
fees from 25 percent to 26 percent; and within FDA. The full descriptions of designated representatives to participate
sponsor fees from 25 percent to 27 these proposed recommendations can be in the focused sessions. Following the
percent. found in the proposed ADUFA IV close of registration, we will determine
Additionally, there were chemistry, Performance Goals and Procedures the amount of time allotted to each
manufacturing, and controls (CMC) Letter. FDA intends to publish in the presenter and the approximate time
enhancements, including: Permitting Federal Register the full text of the each oral presentation is to begin, and
the manufacturing supplements to be proposed ADUFA IV Performance Goals will select and notify participants by
resubmitted as ‘‘Supplement-Changes and Procedures Letter and a summary of October 27, 2017. All requests to make
Being Effected in 30 Days’’ if proposed statutory changes, as well as oral presentations must be received by
deficiencies are not substantial for post them at https://www.fda.gov/ the close of registration on October 26,
manufacturing supplements requiring ForIndustry/UserFees/AnimalDrug 2017. If selected for presentation, any
prior approval according to 21 CFR UserFeeActADUFA/default.htm before presentation materials must be emailed
514.8(b); permitting comparability the public meeting and will provide for to the Cassie Ravo (see FOR FURTHER
protocols as described in 21 CFR a period of 30 days for the public to INFORMATION CONTACT) no later than
514.8(b)(2)(v) to be submitted as provide written comments. October 31, 2017. No commercial or
protocols without substantial data in an FDA will post the agenda promotional material will be permitted
investigational new animal drug (INAD) approximately 5 days before the meeting to be presented or distributed at the
file; and developing guidance for a two- at https://www.fda.gov/ForIndustry/ public meeting.
phased CMC technical section UserFees/AnimalDrugUser Streaming Webcast of the public
submission and review process under FeeActADUFA/default.htm. meeting: This public meeting will also
the INAD file. The Agency agreed to III. Participating in the Public Meeting be webcast.
explore the feasibility of pursuing Event: ADUFA IV Public Meeting.
expanded conditional approvals and of Registration: To register for the public
Event address for attendees: https://
modifying the current requirement that meeting, please contact Cassie Ravo (see
fda.webex.com/fda/onstage/g.php
the use of multiple new animal drugs in FOR FURTHER INFORMATION CONTACT).
?MTID=e9adcd215b7dba5d99361
the same medicated feed (combination Please provide complete contact
b002663e51fe. Date and time: Thursday,
medicated feed) be subject to an information for each attendee, including
November 2, 2017, 9 a.m. Eastern
approved application. The name, title, affiliation, address, email,
Daylight Time (New York, GMT–4).
reauthorization of ADUFA is targeted to and telephone. Also, please self-identify
Duration: 3 hours. Event number: 812
generate $114,000,000 in user fees over as a member of one of the following
395 634. Event password: 110217.
5 years (FY 2014 through FY 2018). stakeholder categories: Scientific or
Teleconference: Provide your number
FDA has published a number of academic experts; veterinary
when you join the event to receive a call
reports that provide useful background professionals; patients and consumer
back. (1) Call one of the following
on ADUFA I, II, and III. ADUFA-related advocacy groups; or the regulated
numbers: Local: 1–301–796–7777; toll
Federal Register notices, guidances, industry, and whether you are
free: 1–855–828–1770. (2) Follow the
legislation, performance reports, and requesting a scheduled presentation.
Registration is free and based on instructions that you hear on the phone.
financial reports can be found at: Cisco Unified MeetingPlace meeting ID:
https://www.fda.gov/ForIndustry/ space availability, with priority given to
early registrants. Persons interested in 812 395 634.
UserFees/AnimalDrugUserFeeAct FDA has verified the Web site
ADUFA/default.htm. attending this public meeting must
addresses in this document, as of the
register by October 26, 2017, midnight
II. Topics for Discussion at the Public date this document publishes in the
Eastern Time. Early registration is
Meeting Federal Register, but Web sites are
recommended because seating is
In preparing the proposed subject to change over time.
limited; therefore, FDA may limit the Transcripts: Please be advised that as
recommendations to Congress for number of participants from each soon as a transcript of the public
ADUFA reauthorization (ADUFA IV), organization. Registrants will receive meeting is available, it will be accessible
we have conducted discussions with the confirmation when they have been at https://www.regulations.gov. It may
regulated industry, and we have accepted. If time and space permit, be viewed at the Dockets Management
consulted with stakeholders as required onsite registration on the day of the Staff (see ADDRESSES). A link to the
by the law. We began the ADUFA public meeting will be provided transcript will also be available on the
reauthorization process with a public beginning at 8:30 a.m. We will let internet at: https://www.fda.gov/
meeting held on May 16, 2016 (81 FR registrants know if registration closes ForIndustry/UserFees/AnimalDrugUser
23313, April 20, 2016). Following the before the day of the public meeting. If
ethrower on DSK3G9T082PROD with NOTICES
FeeActADUFA/ucm042891.htm.
May 2016 public meeting, FDA you need special accommodations due
conducted negotiations with regulated to a disability, please contact Cassie Dated: September 29, 2017.
industry and continued regular Ravo (see FOR FURTHER INFORMATION Anna K. Abram,
consultations with public stakeholders CONTACT) no later than October 26, 2017. Deputy Commissioner for Policy, Planning,
from October 2016 through April 2017. Requests for Oral Presentations: When Legislation, and Analysis.
As directed by Congress, FDA posted registering, you may indicate if you [FR Doc. 2017–21439 Filed 10–4–17; 8:45 am]
minutes of these discussions on its Web wish to present during a public BILLING CODE 4164–01–P
VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/82_FR_46695/page/3.svg)
Document Created: 2017-10-05 00:53:55
Document Modified: 2017-10-05 00:53:55
| 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 public meeting; request for comments. | |
| Dates | The public meeting will be held on November 2, 2017, from 9 a.m. to 12 noon. Submit either electronic or written comments on this public meeting to the docket by November 17, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Cassie Ravo, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-6866, [email protected] | |
| FR Citation | 82 FR 46503 |
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