81 FR 64171 - Biosimilar User Fee Act; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 181 (September 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 181 (September 19, 2016)
| Page Range | 64171-64175 | |
| FR Document | 2016-22442 |
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)] [Notices] [Pages 64171-64175] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22442] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3326] Biosimilar User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect fees and use them for the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting biosimilar [[Page 64172]] biological product user fees in future fiscal years. Following an initial consultation with public stakeholders and discussions with the regulated industry, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider the public views and comments and revise the recommendations as necessary. DATES: The public meeting will be held on October 20, 2016, from 9 a.m. to 2 p.m. Please register for the meeting by October 19, 2016, at http://bsufapublicmeeting.eventbrite.com. Submit electronic or written comments to the public docket by October 19, 2016. ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503, Section A), Silver Spring, MD 20993-0002. Participants must enter through Building 1 and undergo security screening. For more information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-N-3326 for ``Biosimilar User Fee Act; Public Meeting.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FDA will post the agenda approximately 5 days before the meeting at: http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993, 301-796- 4548, FAX: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Introduction FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of BsUFA, the legislation that authorizes FDA to collect user fees and use them for the process for the review of biosimilar biological product applications. The current authorization of the program (BsUFA I) expires in September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the process for the review of biosimilar biological product applications. Section 744I(e)(2) of the FD&C Act (21 U.S.C. 379j-53(e)(2)) requires that after FDA holds negotiations with regulated industry, we do the following: (1) Present recommendations to the relevant Congressional committees, (2) publish recommendations in the Federal Register, (3) provide a period of 30 days for the public to provide written comments on the recommendations, (4) hold a meeting at which the public may present its views on the recommendations, and (5) after consideration of public views and comments, revise the recommendations as necessary. This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements. The purpose of the meeting is to hear the public's views on the proposed recommendations for the reauthorization of BsUFA II. The following information is provided to help potential meeting participants [[Page 64173]] better understand the history and evolution of the BsUFA program and the proposed BsUFA II recommendations. II. What is BsUFA and what does it do? BsUFA is a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain biosimilar biological products. BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act (Pub. L. 112-144) for a period of 5 years. BsUFA's intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better-managed biosimilar biological product review process to make important therapies available to patients sooner without compromising review quality or FDA's high standards for safety, efficacy, and quality. As part of FDA's agreement with industry during each reauthorization, the Agency agrees to certain performance goals. These goals apply to the process for the review of new biosimilar biological product applications, resubmissions of original applications, and new and resubmitted supplements to approved applications. Phased in over the 5 years of BsUFA I, the goals were to review and act on 90 percent of original biosimilar biological product application submissions within 10 months of receipt and resubmitted original biosimilar biological product applications within 6 months of receipt; to review and act on 90 percent of original supplements with clinical data within 10 months of receipt and resubmitted supplements with clinical data within 6 months of receipt; and review and act on 90 percent of manufacturing supplements within 6 months of receipt. III. Proposed BsUFA II Recommendations In preparing the proposed recommendations to Congress for BsUFA reauthorization, FDA conducted discussions with the regulated industry and consulted with stakeholders, as required by the law. We began the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input on the reauthorization and announcing a public meeting that was held on December 18, 2015. The meeting included presentations by FDA and a series of panels with representatives of different stakeholder groups, including patient advocates, consumer groups, regulated industry, health professionals, and academic researchers. The materials from the meeting, including a transcript and Webcast recording, can be found at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. Following the December 2015 public meeting, FDA conducted negotiations with the regulated industry from March 2016 through May 2016. FDA posted minutes of these meetings on its Web site at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. The proposed enhancements for BsUFA II address many of the top priorities identified by public stakeholders, the regulated industry, and FDA. While some of the proposed enhancements are new, many either build on successful enhancements or refine elements from the existing program. The enhancements are proposed in the following areas: Review performance, meeting management, guidance development, and administrative areas (hiring and financial management). The full text of the proposed BsUFA II commitment letter can be found here at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. Each significant new or modified enhancement is described briefly in sections III.A through III.K. A. The Review Cycle FDA and the regulated industry jointly identified an opportunity to reduce multiple review cycles for biosimilar biological products by increasing transparency and communication during the review process of a 351(k) application. For BsUFA II, it is therefore proposed to establish a model for the review of biosimilar biological products similar to the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and original Biologics License Applications (the Program) that was established in the fifth authorization of the Prescription Drug User Fee Act (PDUFA). The Program was first established for PDUFA in 2012. An interim assessment of the Program suggested that it has created conditions that enhance the ability of applicants and FDA reviewers to work toward application approval in the first cycle (see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm). Likewise, it is anticipated that the review model will promote efficiency and effectiveness of the first cycle review process and minimize the number of review cycles necessary for approval for 351(k) applications. The Program will allow for additional communication between FDA review teams and the applicants of biosimilar biological products in the form of pre-submission meetings, mid-cycle communications, and late-cycle meetings, while also adding 60 days to the review timeframe to accommodate this additional interaction. This enhancement is described in section I.B. of the proposed BsUFA II commitment letter. B. Review Goal Extension for Missing Manufacturing Facilities When manufacturing facilities are not adequately identified, this may result in the need for FDA to conduct inspections late in the review process. This can adversely impact FDA's ability to complete application review within the performance goal timeframes. Accordingly, FDA proposes to extend the goal date for an original application or a supplement when FDA identifies a need to inspect a facility that was not included in a comprehensive and readily located list of manufacturing facilities. This enhancement is described in section I.A.5.b of the proposed BsUFA II commitment letter. C. Special Protocol Assessment and Agreement Further clarity is needed regarding the types of clinical study protocols that may qualify for a Special Protocol Assessment and Agreement under BsUFA. Pharmacokinetic (PK) and Pharmacodynamic (PD) similarity studies should be added to the examples provided in the goals letter. It is proposed that the language in the goals is revised to include PK and PD similarity studies. This enhancement is described in section I.H.1.c of the proposed BsUFA II commitment letter. D. Prior Approval Manufacturing Supplements The review goal date for biosimilar prior approval manufacturing supplements is currently 6 months under BsUFA I, compared to 4 months for stand-alone biologics under PDUFA. Therefore, to increase consistency among user fee programs, it is proposed that prior approval manufacturing supplements are reviewed in 4 months, instead of 6 months, with a phased-in performance goal. The language for prior approval supplements is included in section I.A.3 of the proposed BsUFA II commitment letter. E. Meeting Management The enhancements in this section focus on FDA's ability to better manage meetings with sponsors of 351(k) applications. The details for these enhancements can be found in section [[Page 64174]] I.I of the proposed BsUFA II commitment letter. 1. Addition of a Written Response Meeting Format for Biosimilar Initial Advisory (BIA) and Biosimilar Program Development (BPD) Type 2 Meetings Currently, there is no mechanism to grant a meeting request and provide a written response in place of a face-to-face meeting, videoconference, or teleconference. From FY 2013 to FY2015, FDA provided written responses to sponsors for 16 out of 22 meetings that were denied or cancelled due to incomplete, premature, or unnecessary requests in order to support biosimilar development programs. Such responses are not on a user fee clock and are not tracked work. For BsUFA II, it is proposed that for BIA and BPD Type 2 meetings, the sponsor may request a written response to questions rather than a face- to-face meeting, videoconference, or teleconference. If a written response is deemed appropriate, FDA will notify the requester of the date it intends to send the written response. This date will be consistent with the timeframes specified for the specific meeting type. 2. Increase the Scheduling Timeframe for BPD Type 2 Meetings The FDA has had challenges scheduling BPD type 2 meetings within the 75-day timeframe. Scheduling challenges occur due to an increasing number of Type 2 meetings to discuss novel and complex aspects of development that require extensive internal discussion. A review committee must address many of these aspects to ensure implementation of consistent scientific advice and policy concerning biosimilar development. Consequently, FDA is unable to answer and provide comprehensive responses to such questions at meetings within the 75-day timeframe. This results in unresolved issues and additional followup questions that ultimately leads to a delay in a sponsor's overall development program. To provide the necessary time for FDA discussions and to develop comprehensive responses, it is proposed that BPD Type 2 Meetings occur within 90 calendar days, instead of 75 days, from receipt of the meeting request and meeting package with a phased in performance goal. Additionally, it is proposed that the Agency will send preliminary responses to the sponsor's questions contained in the background package no later than five calendar days before the face-to- face videoconference or teleconference meeting date for BPD Type 2 and Type 3 meetings. 3. Reduce the Scheduling Timeframe for Biosimilar Initial Advisory (BIA) Meetings On average, five BIA meetings were scheduled per fiscal year from 2013 to 2015. The content of a BIA meeting is limited to a general discussion on whether a proposed product could be developed as a biosimilar product and to provide high-level advice on the expected content of the development program. Targeted advice on the adequacy of any comparative data or extensive advice for any aspect of an ongoing biosimilar development program is not expected to be provided in a BIA meeting. The current 90-day scheduling timeframe may no longer be appropriate and should be shortened. Therefore, it is proposed for BIA meetings to occur within 75 calendar days, instead of 90 days, from receipt of the meeting request and meeting package. F. Guidance Development FDA has received feedback that additional clarity is needed on regulatory processes and the scientific criteria for biosimilar development and approval to provide certainty to industry and other stakeholders related to Agency expectations. Therefore, it is proposed that FDA revise its guidance entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants'' and update the draft guidance entitled ``Best Practices for Communication Between IND Sponsors and FDA During Drug Development'' to include communications between IND sponsors and FDA during biosimilar biological product development. Additionally, it is proposed that FDA publish draft or final guidance on several issues related to biosimilar biological product development including considerations in demonstrating interchangeability with a reference product; statistical considerations for analytic similarity for biosimilar biological products; processes and further considerations related to post-approval manufacturing changes for biosimilar biological products; clinical pharmacology data to support a demonstration of biosimilarity to a reference product; nonproprietary naming of biological products; and labeling for biosimilar biological products. The proposed goals related to guidance development are described in sections I.I.6 and II of the proposed BsUFA II commitment letter. G. Improving FDA Hiring and Retention of Review Staff To speed and improve development of safe and effective biosimilar biological products for patients, FDA must hire and retain sufficient numbers and types of technical and scientific experts to efficiently conduct reviews of 351(k) applications. In order to strengthen this core function during BsUFA II, FDA proposes to implement a full time equivalent staff-based position management system capability and an online position classification system. In addition, FDA will complete implementation of corporate recruiting practices, augment hiring capacity with expert contractor support, establish a dedicated function for staffing of the human drug review program, establish clear goals for biosimilar review program hiring, and conduct comprehensive and continuous assessments of hiring and retention performance. These enhancements are described in section V of the proposed BsUFA II commitment letter. H. Enhancing Capacity for Biosimilar Guidance Development, Reviewer Training, and Timely Communication In order to accelerate patient access to safe and effective biosimilar biological products and ensure accuracy, consistency, and timeliness FDA needs a more focused and better resourced capacity to coordinate key legal, scientific, review, and outreach functions in FDA's development phase advice and premarket review. It is proposed that FDA strengthen its staff capacity to: (1) Develop new regulations and guidance to clarify scientific criteria for biosimilar development and approval, and to provide certainty to industry and other stakeholders on key regulatory issues including the scope of eligible biosimilar biological products; (2) develop or revise manuals of policy and procedures, standard operating procedures, and review templates to facilitate rapid update and application of new policies and guidance by review staff, and to develop and deliver timely, comprehensive training to all Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research review staff and special government employees involved in the review of 351(k) BLAs; (3) deliver timely information to the public to improve public understanding of biosimilarity and interchangeability; and (4) deliver information concerning the date of first licensure and the reference product exclusivity expiry date, to be included in the Purple [[Page 64175]] Book.\1\ The language for enhanced capacity is included in section III of the proposed BsUFA II commitment letter. --------------------------------------------------------------------------- \1\ The ``Purple Book'' lists biological products, including any interchangeable biological products, licensed by FDA under the Public Health Service Act. --------------------------------------------------------------------------- I. Enhancing Management of User Fee Resources FDA is committed to enhancing management of BsUFA resources and ensuring BsUFA user fee resources are administered, allocated, and reported in an efficient and transparent manner. In BsUFA II, FDA proposes to establish a resource capacity planning function to improve its ability to analyze current resource needs and project future resource needs, to modernize its time reporting approach, to conduct an evaluation of BsUFA program resource management, to publish a 5-year BsUFA financial plan with annual updates, and to convene an annual public meeting, beginning in FY 2019, to discuss the financial plan and progress towards the financial management enhancements. FDA also proposes to reduce the carryover balance to no greater than 21 weeks of the FY 2022 target revenue by the end of FY 2022. These enhancements are described in section IV of the proposed BsUFA II commitment letter. J. Enhancements to Fee Structure and Related Mechanisms for Increased Predictability, Stability, and Efficiency The current BsUFA fee structure references PDUFA fees each fiscal year and calculates biosimilar biological product development program (BPD) fees based on the PDUFA application fee. FDA and industry agreed that the BsUFA II fee structure and the fee setting process could be updated to enhance the predictability and stability of fee amounts and revenues in a manner to improve FDA's ability to engage in long-term financial planning. To address these issues, FDA proposes to discontinue the reduction of the biosimilar biological product application fee by the cumulative BPD fees paid by sponsors, to discontinue the establishment and supplement fees, to rename the product fee as the BsUFA Program fee, to modify the Program fee billing date to minimize the need for multiple billing cycles, and to add a limitation that a sponsor shall not be assessed more than five BsUFA Program fees for a fiscal year for products identified in each distinct approved biosimilar biological product application held by that sponsor. K. Enhancements to User Fee Revenue Amounts and Adjustments FDA and industry agreed that the BsUFA II user fee revenue amounts and fee amounts should be independent of PDUFA and based on BsUFA program costs. FDA proposes to establish fees to generate a total of $45 million in user fee revenue for FY 2018. However, FDA also proposes that it can adjust this amount when setting the user fee amounts published in the FY 2018 Federal Register notice to reflect an updated assessment of the BsUFA workload, with the limitation that this adjustment cannot increase user fee revenue by more than $9 million (i.e. relative to the $45 million specified for FY 2018 user fee revenue). To enhance the predictability of user fee amounts, FDA proposes that the amount for each BsUFA fee cannot increase more than 25 percent from the respective FY2018 fee amount until the capacity planning adjustment is effective and that FDA can otherwise modify the amount of the user fee revenue generated from each fee type each fiscal year. FDA proposes to adjust the annual user fee revenue amount for inflation, to develop a robust methodology for adjusting fees based on the capacity needs of the program, and to introduce an annual operating reserve adjustment to provide for adequate carryover resources. IV. Purpose and Scope of the Meeting If you wish to attend this meeting, visit http://bsufapublicmeeting.eventbrite.com. Please register by October 19, 2016. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. The meeting will include a presentation by FDA and a series of invited panels representing different stakeholder groups identified in the statute (such as patient advocacy groups, consumer advocacy groups, health professionals, and regulated industry). We will also provide an opportunity for other organizations and individuals to make presentations at the meeting or to submit written comments to the docket before the meeting. FDA will also hold an open public comment period at the meeting to give the public an opportunity to present their comments. Registration for open public comment will occur at the registration desk on the day of the meeting and workshop on a first-come, first-served basis. Transcripts: As soon as a transcript is available, FDA will post it at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22442 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
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The burden for this collection of the site visit and answer the data estimates that it will take the program
information is as follows. For each data collectors’ questions. The burden director (or designated individual) of
collection, the respondents includes: (1) related to the completion of Section 2 of the respective regulatory authority 30
The person in charge of the selected the form is specific to the program minutes (0.5 hours) to answer the
facility type (whether it be a health care directors (or designated individuals) of questions related to Section 2 of the
facility, school, or supermarket/grocery the respective regulatory authorities. It form. The total burden estimate for a
store); and (2) the program director (or includes the time it will take to answer data collection, including both the
designated individual) of the respective the data collectors’ questions and is the program director’s and the person in
regulatory authority. To provide the same regardless of the facility type. charge’s responses, in health care
sufficient number of observations To calculate the estimate of the hours facility types is 180 minutes (150+30)(3
needed to conduct a statistically per response, FDA uses the average data hours), in schools is 150 minutes
significant analysis of the data, FDA has collection duration for similar facility (120+30)(2.5 hours), and in retail food
determined that 400 data collections types during FDA’s 2008 Risk Factor stores is 210 minutes (180+30)(3.5
will be required in each of the three Study (Ref. 3) plus an extra 30 minutes hours).
facility types. Therefore, the total (0.5 hours) for the information Based on the number of entry refusals
number of responses will be 2,400 (400 collection related to Section 3, Part B of from the 2013–2014 Risk Factor Study
data collections × 3 facility types × 2 the form. FDA estimates that it will take in the restaurant facility types, we
respondents per data collection). the persons in charge of health care estimate a refusal rate of 2 percent in the
The burden associated with the facility types, schools, and retail food institutional foodservice and retail food
completion of Sections 1 and 3 of the stores 150 minutes (2.5 hours), 120 store facility types. The estimate of the
form is specific to the persons in charge minutes (2 hours), and 180 minutes (3 time per non-respondent is 5 minutes
of the selected facilities. It includes the hours), respectively, to accompany the (0.08 hours) for the person in charge to
time it will take the persons in charge data collectors while they complete listen to the purpose of the visit and
to accompany the data collectors during Sections 1 and 3 of the form. FDA provide a verbal refusal of entry.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Number of
Number of Total annual responses per Total annual Average burden per
Activity responses per non-respond- Total hours
respondents responses non-respond- non-responses response
respondent ents ent
2015–2016 Data Collection (Health Care Facili- 400 1 400 ........................ ........................ ........................ 2.5 .......................... 1,000
ties)—Completion of Sections 1 and 3.
2015–2016 Data Collection (Schools)—Completion 400 1 400 ........................ ........................ ........................ 2 ............................. 800
of Sections 1 and 3.
2015–2016 Data Collection (Retail Food Stores)— 400 1 400 ........................ ........................ ........................ 3 ............................. 1,200
Completion of Sections 1 and 3.
2015–2016 Data Collection-Completion of Section 1,200 1 1,200 ........................ ........................ ........................ 0.5 .......................... 600
2—All Facility Types.
2017–2018 Data Collection-Entry Refusals—All Fa- ........................ ........................ ........................ 24 1 24 0.08 (5 minutes) ..... 1.92
cility Types.
Total Hours .......................................................... ........................ ........................ ........................ ........................ ........................ ........................ ................................ 3,601.92
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References Reduction/UCM423850.pdf. DEPARTMENT OF HEALTH AND
3. ‘‘FDA Report on the Occurrence of HUMAN SERVICES
The following references are on Foodborne Illness Risk Factors in
display in the Division of Dockets Selected Institutional Foodservice, Food and Drug Administration
Management (see ADDRESSES) and are Restaurant, and Retail Food Store
available for viewing by interested Facility Types (2009).’’ Available at: [Docket No. FDA–2015–N–3326]
persons between 9 a.m. and 4 p.m., http://www.fda.gov/downloads/Food/
FoodSafety/RetailFoodProtection/Food Biosimilar User Fee Act; Public
Monday through Friday, and are
borneIllnessandRiskFactorReduction/ Meeting
available electronically at http://
RetailFoodRiskFactorStudies/
www.regulations.gov. FDA has verified UCM224682.pdf. AGENCY: Food and Drug Administration,
the Web site addresses, as of the date 4. FDA National Retail Food Team. ‘‘FDA HHS.
this document publishes in the Federal Trend Analysis Report on the ACTION: Notice of public meeting;
Register, but Web sites are subject to Occurrence of Foodborne Illness Risk request for comments.
change over time. Factors in Selected Institutional
1. ‘‘Report of the FDA Retail Food Program Foodservice, Restaurant, and Retail Food SUMMARY: The Food and Drug
Database of Foodborne Illness Risk Store Facility Types (1998–2008).’’ Administration (FDA or Agency) is
Factors (2000).’’ Available at: http:// Available at: http://www.fda.gov/ announcing a public meeting to discuss
www.fda.gov/downloads/Food/Food downloads/Food/FoodSafety/RetailFood proposed recommendations for the
Safety/RetailFoodProtection/Foodborne Protection/FoodborneIllnessandRisk reauthorization of the Biosimilar User
IllnessandRiskFactorReduction/Retail FactorReduction/RetailFoodRiskFactor
Fee Act (BsUFA) for fiscal years (FYs)
FoodRiskFactorStudies/ucm123546.pdf. Studies/UCM224152.pdf.
2018 through 2022. BsUFA authorizes
mstockstill on DSK3G9T082PROD with NOTICES
2. ‘‘FDA Report on the Occurrence of 5. ‘‘FDA Food Code.’’ Available at: http://
www.fda.gov/FoodCode. FDA to collect fees and use them for the
Foodborne Illness Risk Factors in process for the review of biosimilar
Selected Institutional Foodservice, Dated: September 13, 2016.
Restaurant, and Retail Food Store
biological product applications. The
Leslie Kux, current legislative authority for BsUFA
Facility Types (2004).’’ Available at:
Associate Commissioner for Policy. expires in September 2017. At that time,
http://www.fda.gov/downloads/Food/
GuidanceRegulation/RetailFood [FR Doc. 2016–22438 Filed 9–16–16; 8:45 am] new legislation will be required for FDA
Protection/FoodborneIllnessRiskFactor BILLING CODE 4164–01–P to continue collecting biosimilar
VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1](https://thefederalregister.org/doc/81_FR_64352/page/1.svg)
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Book.1 The language for enhanced K. Enhancements to User Fee Revenue industry). We will also provide an
capacity is included in section III of the Amounts and Adjustments opportunity for other organizations and
proposed BsUFA II commitment letter. FDA and industry agreed that the individuals to make presentations at the
BsUFA II user fee revenue amounts and meeting or to submit written comments
I. Enhancing Management of User Fee to the docket before the meeting.
Resources fee amounts should be independent of
PDUFA and based on BsUFA program FDA will also hold an open public
FDA is committed to enhancing costs. FDA proposes to establish fees to comment period at the meeting to give
management of BsUFA resources and generate a total of $45 million in user the public an opportunity to present
ensuring BsUFA user fee resources are fee revenue for FY 2018. However, FDA their comments. Registration for open
administered, allocated, and reported in also proposes that it can adjust this public comment will occur at the
an efficient and transparent manner. In amount when setting the user fee registration desk on the day of the
BsUFA II, FDA proposes to establish a amounts published in the FY 2018 meeting and workshop on a first-come,
resource capacity planning function to Federal Register notice to reflect an first-served basis.
Transcripts: As soon as a transcript is
improve its ability to analyze current updated assessment of the BsUFA
available, FDA will post it at http://
resource needs and project future workload, with the limitation that this
www.fda.gov/ForIndustry/UserFees/
resource needs, to modernize its time adjustment cannot increase user fee
BiosimilarUserFeeActBsUFA/
reporting approach, to conduct an revenue by more than $9 million (i.e.
ucm461774.htm.
evaluation of BsUFA program resource relative to the $45 million specified for
management, to publish a 5-year BsUFA FY 2018 user fee revenue). To enhance Dated: September 13, 2016.
financial plan with annual updates, and the predictability of user fee amounts, Leslie Kux,
to convene an annual public meeting, FDA proposes that the amount for each Associate Commissioner for Policy.
beginning in FY 2019, to discuss the BsUFA fee cannot increase more than 25 [FR Doc. 2016–22442 Filed 9–16–16; 8:45 am]
financial plan and progress towards the percent from the respective FY2018 fee BILLING CODE 4164–01–P
financial management enhancements. amount until the capacity planning
FDA also proposes to reduce the adjustment is effective and that FDA can
carryover balance to no greater than 21 otherwise modify the amount of the user DEPARTMENT OF HEALTH AND
weeks of the FY 2022 target revenue by fee revenue generated from each fee HUMAN SERVICES
the end of FY 2022. These type each fiscal year. FDA proposes to
enhancements are described in section adjust the annual user fee revenue Food and Drug Administration
IV of the proposed BsUFA II amount for inflation, to develop a robust [Docket No. FDA–2016–N–2673]
commitment letter. methodology for adjusting fees based on
the capacity needs of the program, and Progress Toward Implementing the
J. Enhancements to Fee Structure and to introduce an annual operating reserve Product Identification Requirements of
Related Mechanisms for Increased adjustment to provide for adequate the Drug Supply Chain Security Act;
Predictability, Stability, and Efficiency carryover resources. Public Meeting; Request for Comments
The current BsUFA fee structure IV. Purpose and Scope of the Meeting AGENCY: Food and Drug Administration,
references PDUFA fees each fiscal year HHS.
If you wish to attend this meeting,
and calculates biosimilar biological
visit http:// ACTION: Notice of public meeting;
product development program (BPD)
bsufapublicmeeting.eventbrite.com. request for comments.
fees based on the PDUFA application
Please register by October 19, 2016. If
fee. FDA and industry agreed that the SUMMARY: The Food and Drug
you are unable to attend the meeting in
BsUFA II fee structure and the fee Administration (FDA) is announcing a
person, you can register to view a live
setting process could be updated to public meeting entitled ‘‘Progress
Webcast of the meeting. You will be
enhance the predictability and stability Toward Implementing the Product
asked to indicate in your registration if
of fee amounts and revenues in a Identification Requirements of the Drug
you plan to attend in person or via the
manner to improve FDA’s ability to Supply Chain Security Act.’’ This
Webcast. Seating will be limited, so
engage in long-term financial planning. public meeting is intended to provide
early registration is recommended.
To address these issues, FDA proposes members of the pharmaceutical
Registration is free and will be on a first-
to discontinue the reduction of the distribution supply chain and other
come, first-served basis. However, FDA
biosimilar biological product interested stakeholders an opportunity
may limit the number of participants
application fee by the cumulative BPD to share information with FDA about the
from each organization based on space
fees paid by sponsors, to discontinue efforts underway to implement the Drug
limitations. Registrants will receive
the establishment and supplement fees, Supply Chain Security Act’s (DSCSA’s)
confirmation once they have been
to rename the product fee as the BsUFA product identification requirements,
accepted. Onsite registration on the day
Program fee, to modify the Program fee including the use of product identifiers
of the meeting will be based on space
billing date to minimize the need for to enhance tracing at the product level.
availability. If you need special
multiple billing cycles, and to add a DATES: The public meeting will be held
accommodations because of a disability,
limitation that a sponsor shall not be on October 14, 2016, from 9 a.m. to 4
please contact Amanda Roache (see FOR
assessed more than five BsUFA Program p.m. To permit the widest possible
FURTHER INFORMATION CONTACT) at least 7
fees for a fiscal year for products opportunity to obtain public comment,
days before the meeting.
mstockstill on DSK3G9T082PROD with NOTICES
identified in each distinct approved FDA is soliciting either electronic or
The meeting will include a
biosimilar biological product written comments on all aspects of the
presentation by FDA and a series of
application held by that sponsor. public meeting topics. The deadline for
invited panels representing different
stakeholder groups identified in the submitting comments related to this
1 The ‘‘Purple Book’’ lists biological products,
statute (such as patient advocacy public meeting is November 14, 2016.
including any interchangeable biological products,
licensed by FDA under the Public Health Service groups, consumer advocacy groups, ADDRESSES: The public meeting will be
Act. health professionals, and regulated held at FDA’s White Oak Campus,
VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1](https://thefederalregister.org/doc/81_FR_64352/page/5.svg)
Document Created: 2016-09-17 02:30:41
Document Modified: 2016-09-17 02:30:41
| 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 October 20, 2016, from 9 a.m. to 2 p.m. Please register for the meeting by October 19, 2016, at http://bsufapublicmeeting.eventbrite.com. Submit electronic or written comments to the public docket by October 19, 2016. | |
| Contact | Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993, 301-796- 4548, FAX: 301-847-8443, [email protected] | |
| FR Citation | 81 FR 64171 |
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