Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49377

statutes and regulations. This guidance 2. ‘‘Suggested Format for Developing and Comments submitted electronically, is not subject to Executive Order 12866. Responding to Deficiencies in including attachments, to https:// Accordance with the Least Burdensome www.regulations.gov will be posted to III. Electronic Access Provisions of FDAMA,’’ dated November the docket unchanged. Because your Persons interested in obtaining a copy 2, 2000, available at: https:// comment will be made public, you are of the guidance may do so by www.fda.gov/downloads/Medical Devices/DeviceRegulationandGuidance/ solely responsible for ensuring that your downloading an electronic copy from GuidanceDocuments/ucm073680.pdf. comment does not include any the internet. A search capability for all confidential information that you or a Center for Devices and Radiological Dated: October 20, 2017. third party may not wish to be posted, Health guidance documents is available Leslie Kux, such as medical information, your or at https://www.fda.gov/MedicalDevices/ Associate Commissioner for Policy. anyone else’s Social Security number, or DeviceRegulationandGuidance/ [FR Doc. 2017–23197 Filed 10–24–17; 8:45 am] confidential business information, such GuidanceDocuments/default.htm. BILLING CODE 4164–01–P as a manufacturing process. Please note Guidance documents are also available that if you include your name, contact at https://www.fda.gov/BiologicsBlood information, or other information that Vaccines/GuidanceCompliance DEPARTMENT OF HEALTH AND identifies you in the body of your RegulatoryInformation/default.htm or HUMAN SERVICES comments, that information will be https://www.regulations.gov. Persons posted on https://www.regulations.gov. unable to download an electronic copy Food and Drug Administration • If you want to submit a comment of ‘‘Deciding When to Submit a 510(k) [Docket No. FDA–2011–N–0655] with confidential information that you for a Change to an Existing Device’’ may do not wish to be made available to the send an email request to CDRH- Animal Generic Drug User Fee Act; public, submit the comment as a [email protected] to receive an Recommendations; Request for written/paper submission and in the electronic copy of the document. Please Comments; Extension of Comment manner detailed (see ‘‘Written/Paper use the document number 1500054 to Period Submissions’’ and ‘‘Instructions’’). identify the guidance you are AGENCY: Food and Drug Administration, Written/Paper Submissions requesting. HHS. Submit written/paper submissions as IV. Paperwork Reduction Act of 1995 ACTION: Notice of availability; request follows: This guidance refers to previously for comments; extension of comment • Mail/Hand delivery/Courier (for approved collections of information period. written/paper submissions): Dockets found in FDA regulations. These Management Staff (HFA–305), Food and SUMMARY: The Food and Drug collections of information are subject to Drug Administration, 5630 Fishers Administration (FDA or the Agency) is review by the Office of Management and Lane, Rm. 1061, Rockville, MD 20852. announcing the availability of the • Budget (OMB) under the Paperwork For written/paper comments Animal Generic Drug User Fee Act Reduction Act of 1995 (44 U.S.C. 3501– submitted to the Dockets Management (AGDUFA) reauthorization draft 3520). The collections of information in Staff, FDA will post your comment, as recommendations and extending the 21 CFR part 820 are approved under well as any attachments, except for comment period to allow interested OMB control number 0910–0073; the information submitted, marked and persons 30 days to submit comments on collections of information in 21 CFR identified, as confidential, if submitted these draft recommendations. part 807, subpart E are approved under as detailed in ‘‘Instructions.’’ OMB control number 0910–0120; the DATES: FDA is extending the comment Instructions: All submissions received collections of information in 21 CFR period on the AGDUFA reauthorization must include the Docket No. FDA– part 803 have been approved under and draft recommendations. Submit 2011–N–0655 for ‘‘Animal Generic Drug OMB control number 0910–0437; and either electronic or written comments User Fee Act; Recommendations; the collections of information in 21 CFR on the draft recommendations by Request for Comments; Extension of parts 801 and 809 are approved under November 24, 2017. Comment Period’’ Received comments, OMB control number 0910–0485. ADDRESSES: You may submit comments those filed in a timely manner (see as follows. Please note that late, ADDRESSES), will be placed in the docket V. References untimely filed comments will not be and, except for those submitted as The following references are on considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly display in the Dockets Management be submitted on or before November 24, viewable at https://www.regulations.gov Staff (see ADDRESSES) and are available 2017. The https://www.regulations.gov or at the Dockets Management Staff for viewing by interested persons electronic filing system will accept between 9 a.m. and 4 p.m., Monday between 9 a.m. and 4 p.m., Monday comments until midnight Eastern Time through Friday. • through Friday; they are also available at the end of November 24, 2017. Confidential Submissions—To electronically at https:// Comments received by mail/hand submit a comment with confidential www.regulations.gov. FDA has verified delivery/courier (for written/paper information that you do not wish to be the Web site addresses, as of the date submissions) will be considered timely made publicly available, submit your this document publishes in the Federal if they are postmarked or the delivery comments only as a written/paper Register, but Web sites are subject to service acceptance receipt is on or submission. You should submit two change over time. before that date. copies total. One copy will include the information you claim to be confidential 1. ‘‘The Least Burdensome Provisions of the Electronic Submissions with a heading or cover note that states FDA Modernization Act of 1997: Concept and Principles,’’ dated October Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS following way: CONFIDENTIAL INFORMATION.’’ The 4, 2002, available at: https:// • www.fda.gov/downloads/Medical Federal eRulemaking Portal: Agency will review this copy, including Devices/DeviceRegulationandGuidance/ https://www.regulations.gov. Follow the the claimed confidential information, in GuidanceDocuments/ucm085999.pdf. instructions for submitting comments. its consideration of comments. The

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second copy, which will have the period of 30 days for the public to percent of reactivated applications claimed confidential information provide written comments on such within 120 days (60-day review plus 60- redacted/blacked out, will be available recommendations, (4) hold a meeting at day administrative review) after the for public viewing and posted on which the public may present its views reactivated ANADA submission date. https://www.regulations.gov. Submit on such recommendations, and (5) This shorter review time for reactivated both copies to the Dockets Management consider such public views and ANADAs for which the deficiencies are Staff. If you do not wish your name and comments and revise such determined not to be substantial is not contact information to be made publicly recommendations as necessary. In the intended to prevent the use of minor available, you can provide this Federal Register of October 5, 2017 (82 amendments during Agency review of information on the cover sheet and not FR 46506), we announced a public an application. If the Agency determines in the body of your comments and you meeting to be held on November 2, that the deficiencies are substantial or must identify this information as 2017. In that notice we stated that we new substantial information is ‘‘confidential.’’ Any information marked intended to publish in the Federal provided, the Agency will review and as ‘‘confidential’’ will not be disclosed Register the full text of the proposed act on 90 percent of reactivated except in accordance with 21 CFR 10.20 AGDUFA III Performance Goals and applications within 240 days (180-day and other applicable disclosure law. For Procedures Letter and a summary of review plus 60-day administrative more information about FDA’s posting proposed statutory changes, as well as review) after the reactivated ANADA of comments to public dockets, see 80 post them at https://www.fda.gov/For submission date. FR 56469, September 18, 2015, or access Industry/UserFees/AnimalGenericDrug The Agency will review and act on 90 the information at: https://www.gpo.gov/ UserFeeActAGDUFA/ucm270232.htm, percent of administrative ANADAs fdsys/pkg/FR-2015-09-18/pdf/2015- before the public meeting and would (ANADAs submitted after all scientific 23389.pdf. provide for a period of 30 days for the decisions have been made in the generic Docket: For access to the docket to public to provide written comments. investigational new animal drug read background documents or the This notice announces the availability (JINAD) process, i.e., prior to the electronic and written/paper comments of these draft recommendations and submission of the ANADA) within 60 received, go to https:// extends the comment period to days after the submission date. www.regulations.gov and insert the November 24, 2017 to provide for a Paragraph IV certification applications docket number, found in brackets in the period of 30 days for the public to (section 512(n)(1)(H)(iv) of the FD&C heading of this document, into the comment on these draft Act) submitted as administrative ‘‘Search’’ box and follow the prompts recommendations. After the public ANADAs will be excluded from the and/or go to the Dockets Management meeting and closing of the comment administrative ANADA cohort. The Agency will review and act on 90 Staff, 5630 Fishers Lane, Rm. 1061, period, we will revise the draft percent of Prior Approval Rockville, MD 20852. recommendations as necessary. In manufacturing supplemental ANADAs addition, the Agency will present the FOR FURTHER INFORMATION CONTACT: within 180 days after the submission draft recommendations to the Cassie Ravo, Center for Veterinary date. A Prior Approval manufacturing Congressional committees. Medicine (HFV–10), Food and Drug supplemental ANADA includes: One or Administration, 7500 Standish Pl., II. Proposed AGDUFA III more major manufacturing changes Rockville, MD 20855, 240–402–6866, Recommendations according to § 514.8(b)(2)(ii) (21 CFR [email protected]. 514.8(b)(2)(ii)) and in accordance with A. Enhancing the Process for Premarket SUPPLEMENTARY INFORMATION: Guidance for Industry #83, ‘‘Chemistry, Review I. Background Manufacturing, and Controls Changes to We are proposing the following an Approved NADA or ANADA’’; and FDA is announcing the availability of changes to the performance changes submitted as ‘‘Supplement- the proposed recommendations for the commitments previously established to Changes Being Effected in 30 Days’’ that reauthorization of AGDUFA, which further enhance the process for review require prior approval according to authorizes FDA to collect user fees and of generic new animal drug § 514.8(b)(3)(v)(A). If a Prior Approval use them for the process of reviewing applications. supplement does not clearly identify generic new animal drug applications Beginning October 1, 2018, all any major manufacturing changes, the and associated submissions. The applications and submissions under Prior Approval supplement will be authority for AGDUFA expires section 512(b) of the FD&C Act (21 designated by the Agency as a September 30, 2018. Without new U.S.C. 360b(b)) must be submitted to the ‘‘Supplement—Changes Being Effected’’ legislation, FDA will no longer have the Agency electronically using the with a 270-day review goal (see authority to collect user fees to fund the eSubmitter tool. ‘‘Supplement—Changes Being Effected generic new animal drug review process The Agency will review and act on 90 Manufacturing Supplemental ANADAs for future fiscal years. Section 742(d)(4) percent of original abbreviated new and Reactivations’’ below). of the Federal Food, Drug, and Cosmetic animal drug applications (ANADAs) A submission is incomplete if it Act (the FD&C Act) (21 U.S.C. 379j– within 240 days (180-day review plus requires additional data or information 22(d)(4)) requires that, after holding 60-day administrative review) after the to enable the Agency to complete a negotiations with regulated industry submission date. An application is comprehensive review of the and periodic consultations with incomplete if it would require submission and reach a decision on the stakeholders, and before transmitting additional data or information to enable issue(s) presented in the submission. If the Agency’s final recommendation to the Agency to complete a the Agency determines that the Congress for the reauthorized program comprehensive review of the deficiencies are not substantial for (AGDUFA III), we do the following: (1) application and reach a decision on the manufacturing supplements requiring Present the recommendations to the issue(s) presented in the application. If prior approval, the Agency will allow relevant Congressional committees, (2) the Agency determines that the the manufacturing supplements to be publish such recommendations in the deficiencies are not substantial, the resubmitted as ‘‘Supplement-Changes Federal Register, (3) provide for a Agency will review and act on 90 Being Effected in 30 Days’’ as described

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in § 514.8(b)(3) and the drug made with to be submitted as protocols without Consumer Price Index less food and the change can be distributed 30 days substantial data in a JINAD file. The energy. after the resubmission according to Agency will review and act on 90 The workload adjustment will § 514.8(b)(3)(iv). The Agency will percent of JINAD submissions continue to be calculated per CVM review and act on 90 percent of these consisting of protocols without Program Policy and Procedures Manual reactivated manufacturing supplements substantial data within 75 days after the 1243.3022, except that, for purposes of within 270 days after the resubmission submission date of the protocol. For calculating the workload adjustment, it date of a complete submission. If the potentially more complex comparability Agency determines that the deficiencies protocols, for example sterile process is agreed to reset the base years to fiscal remain substantial or new substantial validation protocols, the sponsor should year (FY) 2014 through FY 2018. There information is provided, prior approval discuss and have Agency concurrence will be no workload adjustment for FY is required according to regarding the appropriate filing strategy. 2019. Workload adjustments are one- § 514.8(b)(3)(v)(A). The Agency will The Agency will continue to allow time adjustments and are calculated review and act on 90 percent of these two-phased Chemistry, Manufacturing, annually. reactivated manufacturing supplements and Controls technical section C. Offset Provision and Excess within 180 days after the resubmission submissions under the JINAD process. Collections date of a complete submission. The Agency and regulated industry The Agency will review and act on 90 are committed to improving the review The proposal adds financial flexibility percent of ‘‘Supplement-Changes Being and business processes that will by eliminating the final year offset of the Effected’’ manufacturing supplemental facilitate the timely scheduling and over collections provision and making ANADAs and reactivations submitted conducting of pre-approval inspections any excess collections available to according to § 514.8(b)(3)(vi) and in (PAIs). To improve the timeliness and enhance the review process in real time. accordance with Guidance for Industry predictability of foreign PAIs, sponsors #83, ‘‘Chemistry, Manufacturing, and In addition, the proposal provides may voluntarily submit: (1) At the authority for the Secretary of Health and Controls Changes to an Approved beginning of the calendar year, a list of NADA or ANADA,’’ including Human Services when setting fees to foreign manufacturing facilities that are reduce a calculated workload manufacturing changes not requiring specified in an abbreviated application, prior approval according to adjustment up to the amount of excess supplemental abbreviated application, § 514.8(b)(3)(iv), within 270 days after collections in the second preceding or generic investigational file and may the submission date. fiscal year. The first fiscal year this be subject to foreign PAIs for the The Agency will review and act on 90 provision could be applied while setting following fiscal year; and (2) a percent of JINAD study submissions fees is fiscal year 2021. within 180 days after the submission notification 30 days prior to submitting date. an abbreviated application, a D. Impact of AGDUFA III Changes on A submission is incomplete if it supplemental abbreviated application, User Fee Revenue would require additional data or or generic investigational file that The FY 2019 baseline for AGDUFA III information to enable the Agency to informs the Agency that the application complete a comprehensive review of the includes a foreign manufacturing is $18,336,340. For each year from FY study submission and reach a decision facility. Should any changes to the 2020 through FY 2023, the annual on the issue(s) presented in the annual list occur after its submission to statutory revenue amounts established submission. If the Agency determines the Agency, the sponsor may provide in section 741(b) of the FD&C Act (21 that the deficiencies are not substantial, the updated information to the Agency. U.S.C. 379j–21(b)) will be further the Agency will review and act on 90 The Agency will keep a record of the adjusted according to the new statutory percent of resubmitted JINAD study number of foreign PAIs conducted for provision for the inflation adjuster and submissions within 60 days after the abbreviated applications, along with the may be further adjusted by the workload receipt date of a complete study average time for completing the PAIs, adjuster, if applicable. and include this information in its submission. This shorter review time for The planned total 5-year revenue for annual performance report. The time for resubmitted JINAD study submissions is AGDUFA I was $27,100,000. The completing the PAI is understood to not intended to prevent the use of minor planned total 5-year revenue for amendments during Agency review of a mean the time from the inspection scheduling request through notification AGDUFA II was $38,100,000, which study submission. If the Agency also included one-time information determines that the deficiencies are to the Center for Veterinary Medicine technology funding in the amount of substantial or new substantial (CVM) of inspectional findings. $850,000 for FY 2014. It is estimated information is provided, the Agency The Agency and regulated industry will review and act on 90 percent of agree that the use of both formal that the planned total 5-year revenue for resubmitted JINAD study submissions meetings (e.g., pre-submission AGDUFA III will be $95,000,000. within 180 days after the receipt date of conferences, workshops) and informal The fee revenue distribution in a complete study submission. communication by both parties is AGDUFA III will remain the same as The Agency will review and act on 90 critical to ensure high submission AGDUFA II: 25 percent in application percent of JINAD submissions quality such that the above performance fees; 37.5 percent in product fees; and consisting of protocols without goals can be achieved. 37.5 percent in sponsor fees. substantial data, that the Agency and B. Inflation Adjuster and Workload the sponsor consider to be an essential Dated: October 20, 2017. Adjuster part of the basis for making the decision Leslie Kux, to approve or not approve an ANADA The Agency and regulated industry Associate Commissioner for Policy. or supplemental ANADA, within 75 agree to change the current fixed 4 [FR Doc. 2017–23173 Filed 10–24–17; 8:45 am] days after the submission date. percent inflation adjuster to a variable BILLING CODE 4164–01–P The Agency will allow comparability inflation adjuster calculated using protocols as described in § 514.8(b)(2)(v) payroll cost and benefits and the

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