Animal Drug User Fee Act; Public Meeting; Request for Comments, 46503-46505 [2017-21439]

Download as PDF Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product TECFIDERA (dimethyl fumarate). TECFIDERA is indicated for treatment of patients with relapsing forms of multiple sclerosis. Subsequent to this approval, the USPTO received patent term restoration applications for TECFIDERA (U.S. Patent Nos. 6,509,376; 7,320,999; 7,619,001; and 7,803,840) from Biogen Idec International GmbH, and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated November 4, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TECFIDERA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. ethrower on DSK3G9T082PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for TECFIDERA is 2,480 days. Of this time, 2,085 days occurred during the testing phase and 395 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: June 14, 2006. FDA has verified the applicant’s claim that the date the investigational new drug application (IND) became effective was on June 14, 2006. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: February 27, 2012. FDA has verified the applicant’s claim that the new drug application (NDA) for TECFIDERA (NDA 204063) was initially submitted on February 27, 2012. 3. The date the application was approved: March 27, 2013. FDA has verified the applicant’s claims that NDA 204063 was approved on March 27, 2013. VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,438 days, 1,144 days, 811 days, or 654 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: September 29, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–21435 Filed 10–4–17; 8:45 am] BILLING CODE 4164–01–P 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. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA, the Agency, or we) is announcing a forthcoming public SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 46503 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. 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 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). E:\FR\FM\05OCN1.SGM 05OCN1 46504 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices ethrower on DSK3G9T082PROD with NOTICES 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 VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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/User Fees/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, cassie.ravo@fda.hhs.gov. 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 E:\FR\FM\05OCN1.SGM 05OCN1 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices ethrower on DSK3G9T082PROD with NOTICES 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 twophased 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/AnimalDrugUserFeeAct ADUFA/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 VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 site at https://www.fda.gov/ForIndustry/ UserFees/AnimalDrugUserFee ActADUFA/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/AnimalDrug UserFeeActADUFA/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/AnimalDrugUser FeeActADUFA/default.htm. 46505 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=e9adcd215b7dba5d99361 b002663e51fe. 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/AnimalDrugUser FeeActADUFA/ucm042891.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 Dated: September 29, 2017. to a disability, please contact Cassie Anna K. Abram, Ravo (see FOR FURTHER INFORMATION CONTACT) no later than October 26, 2017. Deputy Commissioner for Policy, Planning, Requests for Oral Presentations: When Legislation, and Analysis. [FR Doc. 2017–21439 Filed 10–4–17; 8:45 am] registering, you may indicate if you wish to present during a public BILLING CODE 4164–01–P PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46503-46505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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, cassie.ravo@fda.hhs.gov.

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

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