Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments, 44973-44977 [2015-18448]

Download as PDF Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices Based on data shared by another Federal Agency, FDA estimates that 135 establishments will initially submit one report, and then will submit confirmation or update reports on a semiannual basis. FDA estimates that the confirmation or updating of registration information as required by section 905 will take 12 minutes annually per confirmation or update per establishment. FDA estimates that the submission of product listings required by section 905 for each establishment will take 2 hours initially. FDA also estimates that the confirmation or updating of product listing information required by section 905 will take 48 minutes annually for two confirmations or updates per establishment. FDA estimates that obtaining an optional Dun and Bradstreet D–U–N–S number will take 0.5 hours, and that 8 respondents (1 percent × 135 = 1.35 of establishments required to register under section 905, and 5 percent × 135 = 6.75 of submitters required to list ingredients under section 904) will not already have a Dun and Bradstreet D–U– N–S number. FDA estimates that the submission of ingredient listing information as required by section 904 of the act will take 3 hours per tobacco product. Dated: July 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18410 Filed 7–27–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–2537] Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of meeting; notice of draft guidance availability, request for comments. ACTION: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), is announcing the availability of a draft guidance for industry entitled ‘‘Request for Quality Metrics’’ and a public meeting regarding the Agency’s plans associated with a quality metrics reporting program. The draft guidance and public meeting are asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:17 Jul 27, 2015 Jkt 235001 intended to gain stakeholders’ perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the authority of the Food, Drug, and Cosmetic Act (the FD&C Act). The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA’s risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA’s evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved riskbased principles to determine the appropriate reporting category for postapproval manufacturing changes. FDA intends to consider the input from this public meeting as we finalize this guidance and the planned implementation of this program, including FDA’s initial set of requests for quality metrics data. DATES: The meeting will be held on August 24, 2015, from 8:30 a.m. to 5 p.m. The meeting may be extended or end early depending on the level of public participation. Register to attend or present at the meeting by August 7, 2015, (see section V.C. for information on how to register or make a presentation at the meeting). If you cannot attend in person, information about how you can access a live Web cast will be located at http:// www.fda.gov/Drugs/NewsEvents/ ucm451529.htm. Submit either electronic or written comments concerning the draft guidance and collection of information proposed in the draft guidance by September 28, 2015. ADDRESSES: The meeting will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503 Section B/C), Silver Spring, MD 20993– 0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 44973 performed. For parking and security information, please refer to http:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 240–402–7800. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Althea Cuff, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4061, email: Althea.Cuff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background More than a decade ago, FDA launched an initiative to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. As part of this initiative, and in recognition of the increasing complexity of pharmaceutical manufacturing, FDA developed a 21st century vision for manufacturing and quality with input from academia and industry. The desired state was described as follows: ‘‘A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.’’ 1 There has been significant progress toward this vision in the intervening 1 See ‘‘FDA Pharmaceutical Quality Oversight: One Quality Voice’’ at http://www.fda.gov/ downloads/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ UCM442666.pdf. E:\FR\FM\28JYN1.SGM 28JYN1 44974 Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES years, as evidenced by programs and guidance from FDA around major initiatives such as pharmaceutical development and quality by design (QbD), quality risk management and pharmaceutical quality systems, process validation, and process analytical technology (PAT), among others. These programs and guidances are intended to promote effective use of the most current pharmaceutical science and engineering principles and knowledge throughout the lifecycle of a product. Despite these achievements, however, we have not fully realized our 21st century vision for manufacturing and quality—there continue to be indicators of serious product quality defects. The Agency has found that the majority of drug shortages stem from quality concerns—substandard manufacturing facilities or processes are discovered, or significant quality defects are identified in finished product, necessitating remediation efforts to fix the issue, which in turn, may interrupt production, and cause a shortage of drugs.2 Taking action to reduce drug shortages remains a top priority for FDA. The continued existence of product quality issues may point to increased complexities in the supply chain, a lack of innovation in manufacturing, a failure to adopt modern manufacturing technologies and robust quality management systems, or other factors. Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) amended the FD&C Act to provide FDA with a number of new authorities to drive safety and quality throughout the drug supply chain. Section 706 of FDASIA amended section 704(a) of the FD&C Act (21 U.S.C. 374(a)) by adding section 704(a)(4), under which FDA may require the submission of any records or other information that FDA may inspect under section 704 of the FD&C Act, in advance or in lieu of an inspection, by requesting the records or information from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug. As described in the draft guidance, under this authority, FDA intends to make an initial set of requests for quality metrics data to owners and 2 In 2012, for example, based on information collected from manufacturers, FDA determined that 66 percent of disruptions in drug manufacturing were the result of either (1) efforts to address product-specific quality failures or (2) broader efforts to remediate or improve an unsafe manufacturing facility. ‘‘FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages’’, see figure 2, at http://www.fda.gov/downloads/drugs/ drugsafety/drugshortages/ucm372566.pdf. VerDate Sep<11>2014 19:17 Jul 27, 2015 Jkt 235001 operators of certain human drug establishments. FDA intends to make its requests at the time the guidance is finalized and to provide notice of its requests in the Federal Register. FDA would use the data it receives to calculate quality metrics and to inform decisions about how to develop its program. FDA may add to, revise, or remove quality metrics data and establishments in such future requests to reflect the Agency’s understanding of current manufacturing and establishment considerations and the utility of the data received to date. FDA used the following criteria for the selection of the quality metrics described in the guidance: Objective, subject to inspection under section 704 of the FD&C Act, and valuable in assessing the overall state of quality of the product and process, commitment to quality by the manufacturer, and the health (i.e., effective functioning) of the associated Pharmaceutical Quality System(s), while avoiding any undue reporting burden. CGMP regulations for human drugs expect an ongoing program to maintain and evaluate product and process data that relate to product quality (21 CFR 211.180(e)). Manufacturers are expected to use a quality program in order to support process validation, and the metrics described in this guidance could be a part of such a program. As discussed in the guidance, FDA encourages manufacturers to routinely use additional quality metrics beyond the metrics described in this guidance in performing these evaluations. FDA intends to use quality metrics data to further develop the FDA’s riskbased inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA’s evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved riskbased principles to determine the appropriate reporting category for postapproval manufacturing changes. In the context of developing this program, to identify some types of PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 mutually useful and objective quality metrics, FDA has consulted with stakeholders through various trade and professional association meetings, and a Federal Register document we published on February 12, 2013 (78 FR 9928) soliciting initial input on the use of manufacturing quality metrics as it relates to drug shortages. These efforts have generated several categories of quality-related information that CDER and CBER have considered in developing the quality metrics discussed in the guidance. As described in the guidance, FDA intends to collect and use quantitative quality metrics data to calculate four quality metrics. Notably, FDA has considered requesting data on the ‘‘Right First Time’’ metric, which is a measure of the rework/reprocessing rate or the number of lots released without any processing deviations. We believe that a Right First Time metric can be a useful metric for establishments to measure as part of their own quality metrics program and a leading indicator for product quality. However, as part of our stakeholder consultation, we have also received mixed industry feedback on how to define this metric, whether this metric may be less relevant for finished dosage forms than for active pharmaceutical ingredient (API) manufacturing (where rework is more common), and whether this metric is suitably robust for use in our program. We are requesting further input on this topic (see section V.B.). This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on request for quality metrics. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Specific Request for Comments and Information In addition to comments on the guidance generally, FDA is requesting comments and related supporting information on the following topics, as described in the draft guidance: (1) Optional metrics related to quality culture and process capability/ performance, (2) frequency of quality metrics data reporting, (3) an alternative approach to reduce the reporting burden based on the data collection timeframe, and (4) an alternative approach that would allow inclusion of a limited text field for data points or metrics. FDA has described these potential alternative approaches in the draft guidance and is E:\FR\FM\28JYN1.SGM 28JYN1 Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices seeking public comment on these and any other alternative approaches. asabaliauskas on DSK5VPTVN1PROD with NOTICES III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. IV. Paperwork Reduction Act of 1995 The draft guidance contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). The title, description, and respondent description of the information collection are given under this section with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. We invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title: Request for Quality Metrics; Guidance for Industry. Description: FDA intends to use quality metrics data to further develop the FDA’s risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA’s evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly VerDate Sep<11>2014 19:17 Jul 27, 2015 Jkt 235001 controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved riskbased principles to determine the appropriate reporting category for postapproval manufacturing changes. Section 704(a)(4)(A) of the FD&C Act, added by section 706 of FDASIA, authorizes FDA to request from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug in advance or in lieu of an inspection any records or other information that we may inspect under section 704 of the FD&C Act, provided that we request submission of the information within a reasonable time frame, within reasonable limits, and in a reasonable manner. The draft guidance is intended to describe a set of requests for data under section 704(a)(4) of the FD&C Act that FDA intends to give notice of in the Federal Register at the time the guidance is finalized. In general, the information needed to respond to FDA’s proposed requests is developed and maintained in the course of manufacturing drugs under existing current good manufacturing practice (CGMP) for finished pharmaceuticals in part 211 (21 CFR part 211), and for APIs under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), and could be reviewed during an FDA inspection of a drug establishment. FDA has OMB approval for the information collection currently required under part 211 (OMB control number 0910–0139) and, in table 2, we have calculated the burden for preparing and maintaining the information collection for APIs as currently required under section 501(a)(2)(B) of the FD&C Act but not currently included under OMB control number 0910–0139. FDA intends to request quality metrics data from owners and operators of certain establishments registered under section 510 of the FD&C Act (21 U.S.C. 360), as described in the draft guidance. FDA intends to request that such establishments compile reports containing the following quality metrics data, segregated by quarter, by product, and establishment: • The number of lots attempted of the product. • The number of specification-related rejected lots of the product, rejected during or after manufacturing. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 44975 • The number of attempted lots pending disposition for more than 30 days. • The number of out-of-specification (OOS) results for the product, including stability testing. • The number of lot release and stability tests conducted for the product. • The number of OOS results for lot release and stability tests for the product which are invalidated due to lab error. • The number of product quality complaints received for the product. • The number of lots attempted which are released for distribution or for the next stage of manufacturing the product. • If the associated annual product reviews (APRs) or product quality reviews (PQRs) were completed within 30 days of annual due date for the product. • The number of APRs or PQRs required for the product. In addition to the baseline metrics described previously, FDA is requesting public comment on whether to include the option of submitting additional, optional metrics as evidence of manufacturing robustness and a commitment to quality: • Senior Management Engagement— Was each APR or PQR reviewed and approved by the following: (1) The head of the quality unit, (2) the head of the operations unit, (3) both, or (4) neither? • Corrective Action and Preventive Action (CAPA) Effectiveness—What percentage of your corrective actions involved re-training of personnel (i.e., a root cause of the deviation is lack of adequate training)? • Process Capability/Performance—A ‘‘yes’’ or ‘‘no’’ value of whether the establishment’s management calculated a process capability or performance index for each critical quality attribute as part of that product’s APR or PQR. • Process Capability/Performance—A ‘‘yes’’ or ‘‘no’’ value of whether the establishment’s management has a policy of requiring a CAPA at some lower process capability or performance index. • Process Capability/Performance—If ‘‘yes’’ to the previous question—What is the process capability or performance index that triggers a CAPA? If ‘‘no’’ to the previous question—please do not respond. We estimate the submission of approximately 63,000 product reports to FDA containing the 15 quality metrics data outlined in this document and described in the draft guidance (‘‘Total Annual Reponses’’ in table 1). We estimate that approximately 6,300 establishments will compile and submit these reports, including covered E:\FR\FM\28JYN1.SGM 28JYN1 44976 Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices establishments, reporting establishments, and unregistered foreign establishments, as described in the draft guidance (‘‘Number of Respondents’’ in table 1). We specifically request comment on our estimate of 6,300 establishments and the types of establishments that will participate in compiling and reporting quality metrics data. Our estimate of 63,000 reports is based on the following: Approximately 25,000 reports for drugs subject to approved applications (that is, drugs subject to either approved applications under section 505 of the FD&C Act (21 U.S.C. 355) or under section 351 of the PHS Act, or covered by a submission to a drug master file that is intended to support an application, and approximately 38,000 reports for drugs not subject to approved applications (that is, drugs not subject to either approved applications under section 505 of the FD&C Act or under section 351 of the PHS Act (e.g., drugs marketed pursuant to an OTC monograph and marketed unapproved drugs)). Our estimate of 6,300 establishments is based on data from FDA’s Document Archiving, Reporting & Regulatory Tracking System and the Electronic Drug Registration and Listing System. We estimate that reporting the quality metrics data described previously for each affected product will take approximately 10.6 hours (‘‘Average Burden per Response’’ in table 1). This is a weighted average of the estimate for ‘‘drugs subject to approved applications’’ (finished product and API) (15.75 hours) and ‘‘drugs not subject to approved applications’’ (finished product and API) (7 hours). The time estimate for application and non-application products differs because the groupings are different (e.g., different strengths are grouped in an application and are not grouped for national drug code). These burden hour estimates are based on information provided by CGMP regulatory compliance experts at FDA and in industry. Therefore, we estimate approximately 667,800 total burden hours for compiling and reporting quality metrics data under the draft guidance (‘‘Total Hours’’ in table 1). We believe that the estimated burden for the initial set of requests represents a conservative estimate of the annual burden of responding to any future information requests under the quality metrics program. The burden hour estimate includes the time for compiling information that we understand is currently developed and maintained in the course of manufacturing drugs in compliance with part 211 and section 501(a)(2)(B) of the FD&C Act, and the time for populating spreadsheet(s) for reporting to FDA. The estimate does not include burden hours currently approved under OMB control number 0910–0139 for information collection under part 211. In table 2, we have calculated the burden for information collection for APIs as currently required under section 501(a)(2)(B) of the FD&C Act but not currently included under OMB control number 0910–0139. The draft guidance requests that all reports be submitted through the FDA Electronic Submission Gateway (ESG). We are not estimating any additional burden associated with accessing the ESG because reporting establishments, which are subject to FDA’s establishment registration and drug listing regulations (21 CFR part 207), are required to use the ESG to submit information, and the burdens associated with these submissions are approved under OMB control number 0910–0045. To date, we have not identified any reporting establishments that are not already reporting to the ESG. In table 1, we estimate the reporting burden for the information collection in the draft guidance. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Draft guidance for industry on request for quality metrics Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Collecting and Reporting to FDA Quality Metric Inputs ...... 6,300 10 63,000 10.6 hours 667,800 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In table 2, we estimate the recordkeeping burden for preparing and maintaining CGMP records for APIs that are not currently included under OMB control number 0910–0139. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Section 501(a)(2)(B) of the FD&C Act Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Preparing and Maintaining CGMP Records for APIs (not currently included under OMB control number 0910– 0139) ................................................................................ 1,260 256 322,560 .82 hours 264,499 asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Title: Request for Quality Metrics; Public Meeting. The information collection associated with the public meeting is exempt from OMB regulations on the PRA as follows: 5 CFR 1320.3(h)(8) (exemption from the definition of ‘‘information’’): Facts or opinions obtained or solicited at or in connection with public hearings or VerDate Sep<11>2014 20:00 Jul 27, 2015 Jkt 235001 meetings. 5 CFR 1320.3(h)(4) (exemption from the definition of ‘‘information’’): Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration of the comment. E:\FR\FM\28JYN1.SGM 28JYN1 Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices V. Attendance and/or Participation at the Public Meeting asabaliauskas on DSK5VPTVN1PROD with NOTICES A. Purpose and Scope of the Meeting The purpose of this meeting and public docket is for CDER and CBER to hear from stakeholders any questions, concerns, and suggestions regarding the proposed plans for the scope and implementation of the quality metrics reporting program proposed in this guidance. B. Questions to Stakeholders FDA seeks input from stakeholders and other members of the public on the following meeting questions: 1. Are there other objective metrics that FDA should request in advance of or in lieu of an inspection that FDA should collect to improve our understanding of products and establishments for purposes of more informed, risk-based inspection scheduling and identification of potential product shortages? 2. Are the definitions of the metrics and associated data requests selected adequate and clear? 3. Are the metrics requested from each business segment/type clear and appropriate? 4. Should the Agency explore collecting metrics from high-risk excipient producers, and if so, which excipients should be considered highrisk and what metrics should apply? 5. Should the Agency explore collecting metrics from the medical gas manufacturing industry? 6. Should the Agency add the ‘‘Right First Time’’ metric (see section I.), and if so, should the definition be a rework/ reprocessing rate or a measure of lots manufactured without processing deviations? 7. What data standards/mechanisms would be useful to aid reporting and how should the submissions be structured? 8. Are there reporting hurdles to collecting metrics by reporting establishment/product (segmented by site) versus by site (segmented by product), and how can they be overcome? 9. FDA may consider whether to require the submission of quality metrics on a recurring basis. How frequently should metrics be reported and/or segmented within the reporting period (e.g., annually, semiannually, or quarterly)? C. Meeting Participation and Request To Present The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited VerDate Sep<11>2014 19:17 Jul 27, 2015 Jkt 235001 seating. Attendance will be free and on a first-come, first-served basis. If you wish to attend (either in person or by Web cast (see Streaming Web Cast of the Public Meeting)) and/or present at the meeting, please register for the meeting and/or make a request for oral presentations or comments by visiting https://qualitymetrics-publicmeeting.eventbrite.com on or before August 7, 2015. The registration request should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number, and priority number(s)). Those without email access can register by contacting Althea Cuff by August 7, 2015 (see FOR FURTHER INFORMATION CONTACT). FDA will try to accommodate all persons who wish to make a presentation. Individuals wishing to present should identify the number of the topic, or topics, they wish to address (see section V.B.). This will help FDA organize the presentations. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presentation will depend on the number of individuals who wish to speak. Once FDA notifies registered presenters of their scheduled times, they are encouraged to submit an electronic copy of their presentation to Althea Cuff at Althea.Cuff@fda.hhs.gov on or before August 7, 2015. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make a presentation. Persons registered to make an oral presentation are encouraged to arrive at the meeting room early and check in at the onsite registration table to confirm their designated presentation time. An agenda for the meeting and other background materials will be made available 3 days before the meeting at http://www.fda.gov/Drugs/NewsEvents/ ucm451529.htm. If you need special accommodations because of a disability, please contact Althea Cuff (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. Meeting Registration and Request to Present: The meeting is free and seating will be on a first-come, first-served basis. If you wish to attend or make an oral presentation, see section V.C. for information on how to register and the deadline for registration. If you cannot attend in person, information about how you can access a live Web cast will be located at http://www.fda.gov/Drugs/ NewsEvents/ucm451529.htm. Transcripts: As soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may also be viewed at the Division of Dockets PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 44977 Management (see ADDRESSES). A transcript will also be available in either hard copy or on CD–ROM, after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Streaming Web Cast of the Public Meeting: For those unable to attend in person, FDA will provide a live Web cast of the meeting. To join the meeting via the Web cast, please go to https:// collaboration.fda.gov/qmpm2015/. An agenda will be posted on the FDA Web site at http://www.fda.gov/Drugs/News Events/ucm451529.htm prior to the meeting. Docket Comments: Regardless of attendance at the public meeting, interested persons may submit either electronic or written comments regarding this document to the public docket (see ADDRESSES) by (see DATES). Given that time will be limited at the public meeting, FDA encourages all interested persons to comment in writing to ensure that their comments are considered. VI. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm or http:// www.regulations.gov. Dated: July 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18448 Filed 7–27–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Chronic Fatigue Syndrome Advisory Committee Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public. SUMMARY: E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44973-44977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18448]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2537]


Request for Quality Metrics; Notice of Draft Guidance 
Availability and Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting; notice of draft guidance availability, 
request for comments.

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SUMMARY: The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research (CDER) and Center for Biologics Evaluation and 
Research (CBER), is announcing the availability of a draft guidance for 
industry entitled ``Request for Quality Metrics'' and a public meeting 
regarding the Agency's plans associated with a quality metrics 
reporting program. The draft guidance and public meeting are intended 
to gain stakeholders' perspectives on various aspects of the 
development and planned implementation of a quality metrics program 
launched under the authority of the Food, Drug, and Cosmetic Act (the 
FD&C Act). The guidance includes an explanation of how FDA intends to 
use quality metrics data to further develop the FDA's risk-based 
inspection scheduling, to identify situations in which there may be a 
risk for drug supply disruption, to improve the efficiency and 
effectiveness of establishment inspections, and to improve FDA's 
evaluation of drug manufacturing and control operations. FDA expects 
that the initial use of the metrics will be to consider a decreased 
surveillance inspection frequency for certain establishments. For 
example, establishments that have highly controlled manufacturing 
processes have the potential to be inspected less often (as a lower 
priority for inspection) than similar establishments that demonstrate 
uncontrolled processes (as a higher priority for inspection). In 
addition, FDA intends to consider whether these metrics may provide a 
basis for FDA to use improved risk-based principles to determine the 
appropriate reporting category for postapproval manufacturing changes. 
FDA intends to consider the input from this public meeting as we 
finalize this guidance and the planned implementation of this program, 
including FDA's initial set of requests for quality metrics data.

DATES: The meeting will be held on August 24, 2015, from 8:30 a.m. to 5 
p.m. The meeting may be extended or end early depending on the level of 
public participation. Register to attend or present at the meeting by 
August 7, 2015, (see section V.C. for information on how to register or 
make a presentation at the meeting). If you cannot attend in person, 
information about how you can access a live Web cast will be located at 
http://www.fda.gov/Drugs/NewsEvents/ucm451529.htm.
    Submit either electronic or written comments concerning the draft 
guidance and collection of information proposed in the draft guidance 
by September 28, 2015.

ADDRESSES: The meeting will be held at FDA White Oak Campus, 10903 New 
Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503 
Section B/C), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1, where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911. Send one self-addressed adhesive label to assist 
that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document. The draft guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-7800.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. All comments should be identified with 
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-4061, email: Althea.Cuff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    More than a decade ago, FDA launched an initiative to encourage the 
implementation of a modern, risk-based pharmaceutical quality 
assessment system. As part of this initiative, and in recognition of 
the increasing complexity of pharmaceutical manufacturing, FDA 
developed a 21st century vision for manufacturing and quality with 
input from academia and industry. The desired state was described as 
follows: ``A maximally efficient, agile, flexible pharmaceutical 
manufacturing sector that reliably produces high-quality drug products 
without extensive regulatory oversight.'' \1\
---------------------------------------------------------------------------

    \1\ See ``FDA Pharmaceutical Quality Oversight: One Quality 
Voice'' at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf.
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    There has been significant progress toward this vision in the 
intervening

[[Page 44974]]

years, as evidenced by programs and guidance from FDA around major 
initiatives such as pharmaceutical development and quality by design 
(QbD), quality risk management and pharmaceutical quality systems, 
process validation, and process analytical technology (PAT), among 
others. These programs and guidances are intended to promote effective 
use of the most current pharmaceutical science and engineering 
principles and knowledge throughout the lifecycle of a product.
    Despite these achievements, however, we have not fully realized our 
21st century vision for manufacturing and quality--there continue to be 
indicators of serious product quality defects. The Agency has found 
that the majority of drug shortages stem from quality concerns--
substandard manufacturing facilities or processes are discovered, or 
significant quality defects are identified in finished product, 
necessitating remediation efforts to fix the issue, which in turn, may 
interrupt production, and cause a shortage of drugs.\2\ Taking action 
to reduce drug shortages remains a top priority for FDA.
---------------------------------------------------------------------------

    \2\ In 2012, for example, based on information collected from 
manufacturers, FDA determined that 66 percent of disruptions in drug 
manufacturing were the result of either (1) efforts to address 
product-specific quality failures or (2) broader efforts to 
remediate or improve an unsafe manufacturing facility. ``FDA's 
Strategic Plan for Preventing and Mitigating Drug Shortages'', see 
figure 2, at http://www.fda.gov/downloads/drugs/drugsafety/drugshortages/ucm372566.pdf.
---------------------------------------------------------------------------

    The continued existence of product quality issues may point to 
increased complexities in the supply chain, a lack of innovation in 
manufacturing, a failure to adopt modern manufacturing technologies and 
robust quality management systems, or other factors. Title VII of the 
Food and Drug Administration Safety and Innovation Act (FDASIA) amended 
the FD&C Act to provide FDA with a number of new authorities to drive 
safety and quality throughout the drug supply chain. Section 706 of 
FDASIA amended section 704(a) of the FD&C Act (21 U.S.C. 374(a)) by 
adding section 704(a)(4), under which FDA may require the submission of 
any records or other information that FDA may inspect under section 704 
of the FD&C Act, in advance or in lieu of an inspection, by requesting 
the records or information from a person that owns or operates an 
establishment that is engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug. As described in the 
draft guidance, under this authority, FDA intends to make an initial 
set of requests for quality metrics data to owners and operators of 
certain human drug establishments. FDA intends to make its requests at 
the time the guidance is finalized and to provide notice of its 
requests in the Federal Register. FDA would use the data it receives to 
calculate quality metrics and to inform decisions about how to develop 
its program. FDA may add to, revise, or remove quality metrics data and 
establishments in such future requests to reflect the Agency's 
understanding of current manufacturing and establishment considerations 
and the utility of the data received to date.
    FDA used the following criteria for the selection of the quality 
metrics described in the guidance: Objective, subject to inspection 
under section 704 of the FD&C Act, and valuable in assessing the 
overall state of quality of the product and process, commitment to 
quality by the manufacturer, and the health (i.e., effective 
functioning) of the associated Pharmaceutical Quality System(s), while 
avoiding any undue reporting burden.
    CGMP regulations for human drugs expect an ongoing program to 
maintain and evaluate product and process data that relate to product 
quality (21 CFR 211.180(e)). Manufacturers are expected to use a 
quality program in order to support process validation, and the metrics 
described in this guidance could be a part of such a program. As 
discussed in the guidance, FDA encourages manufacturers to routinely 
use additional quality metrics beyond the metrics described in this 
guidance in performing these evaluations.
    FDA intends to use quality metrics data to further develop the 
FDA's risk-based inspection scheduling, to identify situations in which 
there may be a risk for drug supply disruption, to improve the 
efficiency and effectiveness of establishment inspections, and to 
improve FDA's evaluation of drug manufacturing and control operations. 
FDA expects that the initial use of the metrics will be to consider a 
decreased surveillance inspection frequency for certain establishments. 
For example, establishments that have highly controlled manufacturing 
processes have the potential to be inspected less often (as a lower 
priority for inspection) than similar establishments that demonstrate 
uncontrolled processes (as a higher priority for inspection). In 
addition, FDA intends to consider whether these metrics may provide a 
basis for FDA to use improved risk-based principles to determine the 
appropriate reporting category for postapproval manufacturing changes.
    In the context of developing this program, to identify some types 
of mutually useful and objective quality metrics, FDA has consulted 
with stakeholders through various trade and professional association 
meetings, and a Federal Register document we published on February 12, 
2013 (78 FR 9928) soliciting initial input on the use of manufacturing 
quality metrics as it relates to drug shortages. These efforts have 
generated several categories of quality-related information that CDER 
and CBER have considered in developing the quality metrics discussed in 
the guidance.
    As described in the guidance, FDA intends to collect and use 
quantitative quality metrics data to calculate four quality metrics. 
Notably, FDA has considered requesting data on the ``Right First Time'' 
metric, which is a measure of the rework/reprocessing rate or the 
number of lots released without any processing deviations. We believe 
that a Right First Time metric can be a useful metric for 
establishments to measure as part of their own quality metrics program 
and a leading indicator for product quality. However, as part of our 
stakeholder consultation, we have also received mixed industry feedback 
on how to define this metric, whether this metric may be less relevant 
for finished dosage forms than for active pharmaceutical ingredient 
(API) manufacturing (where rework is more common), and whether this 
metric is suitably robust for use in our program. We are requesting 
further input on this topic (see section V.B.).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on request for 
quality metrics. It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations.

II. Specific Request for Comments and Information

    In addition to comments on the guidance generally, FDA is 
requesting comments and related supporting information on the following 
topics, as described in the draft guidance: (1) Optional metrics 
related to quality culture and process capability/performance, (2) 
frequency of quality metrics data reporting, (3) an alternative 
approach to reduce the reporting burden based on the data collection 
timeframe, and (4) an alternative approach that would allow inclusion 
of a limited text field for data points or metrics. FDA has described 
these potential alternative approaches in the draft guidance and is

[[Page 44975]]

seeking public comment on these and any other alternative approaches.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    The draft guidance contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520). The title, description, and respondent 
description of the information collection are given under this section 
with an estimate of the annual reporting burden. Included in the 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing the collection of information.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Request for Quality Metrics; Guidance for Industry.
    Description: FDA intends to use quality metrics data to further 
develop the FDA's risk-based inspection scheduling, to identify 
situations in which there may be a risk for drug supply disruption, to 
improve the efficiency and effectiveness of establishment inspections, 
and to improve FDA's evaluation of drug manufacturing and control 
operations. FDA expects that the initial use of the metrics will be to 
consider a decreased surveillance inspection frequency for certain 
establishments. For example, establishments that have highly controlled 
manufacturing processes have the potential to be inspected less often 
(as a lower priority for inspection) than similar establishments that 
demonstrate uncontrolled processes (as a higher priority for 
inspection). In addition, FDA intends to consider whether these metrics 
may provide a basis for FDA to use improved risk-based principles to 
determine the appropriate reporting category for postapproval 
manufacturing changes.
    Section 704(a)(4)(A) of the FD&C Act, added by section 706 of 
FDASIA, authorizes FDA to request from a person that owns or operates 
an establishment that is engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug in advance or in lieu 
of an inspection any records or other information that we may inspect 
under section 704 of the FD&C Act, provided that we request submission 
of the information within a reasonable time frame, within reasonable 
limits, and in a reasonable manner. The draft guidance is intended to 
describe a set of requests for data under section 704(a)(4) of the FD&C 
Act that FDA intends to give notice of in the Federal Register at the 
time the guidance is finalized. In general, the information needed to 
respond to FDA's proposed requests is developed and maintained in the 
course of manufacturing drugs under existing current good manufacturing 
practice (CGMP) for finished pharmaceuticals in part 211 (21 CFR part 
211), and for APIs under section 501(a)(2)(B) of the FD&C Act (21 
U.S.C. 351(a)(2)(B)), and could be reviewed during an FDA inspection of 
a drug establishment. FDA has OMB approval for the information 
collection currently required under part 211 (OMB control number 0910-
0139) and, in table 2, we have calculated the burden for preparing and 
maintaining the information collection for APIs as currently required 
under section 501(a)(2)(B) of the FD&C Act but not currently included 
under OMB control number 0910-0139.
    FDA intends to request quality metrics data from owners and 
operators of certain establishments registered under section 510 of the 
FD&C Act (21 U.S.C. 360), as described in the draft guidance. FDA 
intends to request that such establishments compile reports containing 
the following quality metrics data, segregated by quarter, by product, 
and establishment:
     The number of lots attempted of the product.
     The number of specification-related rejected lots of the 
product, rejected during or after manufacturing.
     The number of attempted lots pending disposition for more 
than 30 days.
     The number of out-of-specification (OOS) results for the 
product, including stability testing.
     The number of lot release and stability tests conducted 
for the product.
     The number of OOS results for lot release and stability 
tests for the product which are invalidated due to lab error.
     The number of product quality complaints received for the 
product.
     The number of lots attempted which are released for 
distribution or for the next stage of manufacturing the product.
     If the associated annual product reviews (APRs) or product 
quality reviews (PQRs) were completed within 30 days of annual due date 
for the product.
     The number of APRs or PQRs required for the product.
    In addition to the baseline metrics described previously, FDA is 
requesting public comment on whether to include the option of 
submitting additional, optional metrics as evidence of manufacturing 
robustness and a commitment to quality:
     Senior Management Engagement--Was each APR or PQR reviewed 
and approved by the following: (1) The head of the quality unit, (2) 
the head of the operations unit, (3) both, or (4) neither?
     Corrective Action and Preventive Action (CAPA) 
Effectiveness--What percentage of your corrective actions involved re-
training of personnel (i.e., a root cause of the deviation is lack of 
adequate training)?
     Process Capability/Performance--A ``yes'' or ``no'' value 
of whether the establishment's management calculated a process 
capability or performance index for each critical quality attribute as 
part of that product's APR or PQR.
     Process Capability/Performance--A ``yes'' or ``no'' value 
of whether the establishment's management has a policy of requiring a 
CAPA at some lower process capability or performance index.
     Process Capability/Performance--If ``yes'' to the previous 
question--What is the process capability or performance index that 
triggers a CAPA? If ``no'' to the previous question--please do not 
respond.
    We estimate the submission of approximately 63,000 product reports 
to FDA containing the 15 quality metrics data outlined in this document 
and described in the draft guidance (``Total Annual Reponses'' in table 
1). We estimate that approximately 6,300 establishments will compile 
and submit these reports, including covered

[[Page 44976]]

establishments, reporting establishments, and unregistered foreign 
establishments, as described in the draft guidance (``Number of 
Respondents'' in table 1). We specifically request comment on our 
estimate of 6,300 establishments and the types of establishments that 
will participate in compiling and reporting quality metrics data.
    Our estimate of 63,000 reports is based on the following: 
Approximately 25,000 reports for drugs subject to approved applications 
(that is, drugs subject to either approved applications under section 
505 of the FD&C Act (21 U.S.C. 355) or under section 351 of the PHS 
Act, or covered by a submission to a drug master file that is intended 
to support an application, and approximately 38,000 reports for drugs 
not subject to approved applications (that is, drugs not subject to 
either approved applications under section 505 of the FD&C Act or under 
section 351 of the PHS Act (e.g., drugs marketed pursuant to an OTC 
monograph and marketed unapproved drugs)).
    Our estimate of 6,300 establishments is based on data from FDA's 
Document Archiving, Reporting & Regulatory Tracking System and the 
Electronic Drug Registration and Listing System. We estimate that 
reporting the quality metrics data described previously for each 
affected product will take approximately 10.6 hours (``Average Burden 
per Response'' in table 1). This is a weighted average of the estimate 
for ``drugs subject to approved applications'' (finished product and 
API) (15.75 hours) and ``drugs not subject to approved applications'' 
(finished product and API) (7 hours). The time estimate for application 
and non-application products differs because the groupings are 
different (e.g., different strengths are grouped in an application and 
are not grouped for national drug code). These burden hour estimates 
are based on information provided by CGMP regulatory compliance experts 
at FDA and in industry. Therefore, we estimate approximately 667,800 
total burden hours for compiling and reporting quality metrics data 
under the draft guidance (``Total Hours'' in table 1). We believe that 
the estimated burden for the initial set of requests represents a 
conservative estimate of the annual burden of responding to any future 
information requests under the quality metrics program.
    The burden hour estimate includes the time for compiling 
information that we understand is currently developed and maintained in 
the course of manufacturing drugs in compliance with part 211 and 
section 501(a)(2)(B) of the FD&C Act, and the time for populating 
spreadsheet(s) for reporting to FDA. The estimate does not include 
burden hours currently approved under OMB control number 0910-0139 for 
information collection under part 211. In table 2, we have calculated 
the burden for information collection for APIs as currently required 
under section 501(a)(2)(B) of the FD&C Act but not currently included 
under OMB control number 0910-0139.
    The draft guidance requests that all reports be submitted through 
the FDA Electronic Submission Gateway (ESG). We are not estimating any 
additional burden associated with accessing the ESG because reporting 
establishments, which are subject to FDA's establishment registration 
and drug listing regulations (21 CFR part 207), are required to use the 
ESG to submit information, and the burdens associated with these 
submissions are approved under OMB control number 0910-0045. To date, 
we have not identified any reporting establishments that are not 
already reporting to the ESG.
    In table 1, we estimate the reporting burden for the information 
collection in the draft guidance.

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
     Draft guidance for industry on request for quality metrics         Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collecting and Reporting to FDA Quality Metric Inputs..............           6,300               10           63,000       10.6 hours          667,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In table 2, we estimate the recordkeeping burden for preparing and 
maintaining CGMP records for APIs that are not currently included under 
OMB control number 0910-0139.

                                                    Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                Section 501(a)(2)(B) of the FD&C Act                    Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing and Maintaining CGMP Records for APIs (not currently                1,260              256          322,560        .82 hours          264,499
 included under OMB control number 0910-0139)......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Title: Request for Quality Metrics; Public Meeting.
    The information collection associated with the public meeting is 
exempt from OMB regulations on the PRA as follows: 5 CFR 1320.3(h)(8) 
(exemption from the definition of ``information''): Facts or opinions 
obtained or solicited at or in connection with public hearings or 
meetings. 5 CFR 1320.3(h)(4) (exemption from the definition of 
``information''): Facts or opinions submitted in response to general 
solicitations of comments from the public, published in the Federal 
Register or other publications, regardless of the form or format 
thereof, provided that no person is required to supply specific 
information pertaining to the commenter, other than that necessary for 
self-identification, as a condition of the agency's full consideration 
of the comment.

[[Page 44977]]

V. Attendance and/or Participation at the Public Meeting

A. Purpose and Scope of the Meeting

    The purpose of this meeting and public docket is for CDER and CBER 
to hear from stakeholders any questions, concerns, and suggestions 
regarding the proposed plans for the scope and implementation of the 
quality metrics reporting program proposed in this guidance.

B. Questions to Stakeholders

    FDA seeks input from stakeholders and other members of the public 
on the following meeting questions:
    1. Are there other objective metrics that FDA should request in 
advance of or in lieu of an inspection that FDA should collect to 
improve our understanding of products and establishments for purposes 
of more informed, risk-based inspection scheduling and identification 
of potential product shortages?
    2. Are the definitions of the metrics and associated data requests 
selected adequate and clear?
    3. Are the metrics requested from each business segment/type clear 
and appropriate?
    4. Should the Agency explore collecting metrics from high-risk 
excipient producers, and if so, which excipients should be considered 
high-risk and what metrics should apply?
    5. Should the Agency explore collecting metrics from the medical 
gas manufacturing industry?
    6. Should the Agency add the ``Right First Time'' metric (see 
section I.), and if so, should the definition be a rework/reprocessing 
rate or a measure of lots manufactured without processing deviations?
    7. What data standards/mechanisms would be useful to aid reporting 
and how should the submissions be structured?
    8. Are there reporting hurdles to collecting metrics by reporting 
establishment/product (segmented by site) versus by site (segmented by 
product), and how can they be overcome?
    9. FDA may consider whether to require the submission of quality 
metrics on a recurring basis. How frequently should metrics be reported 
and/or segmented within the reporting period (e.g., annually, 
semiannually, or quarterly)?

C. Meeting Participation and Request To Present

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures and limited seating. Attendance will 
be free and on a first-come, first-served basis. If you wish to attend 
(either in person or by Web cast (see Streaming Web Cast of the Public 
Meeting)) and/or present at the meeting, please register for the 
meeting and/or make a request for oral presentations or comments by 
visiting https://qualitymetrics-public-meeting.eventbrite.com on or 
before August 7, 2015. The registration request should contain complete 
contact information for each attendee (i.e., name, title, affiliation, 
address, email address, telephone number, and priority number(s)). 
Those without email access can register by contacting Althea Cuff by 
August 7, 2015 (see FOR FURTHER INFORMATION CONTACT).
    FDA will try to accommodate all persons who wish to make a 
presentation. Individuals wishing to present should identify the number 
of the topic, or topics, they wish to address (see section V.B.). This 
will help FDA organize the presentations. FDA will notify registered 
presenters of their scheduled presentation times. The time allotted for 
each presentation will depend on the number of individuals who wish to 
speak. Once FDA notifies registered presenters of their scheduled 
times, they are encouraged to submit an electronic copy of their 
presentation to Althea Cuff at Althea.Cuff@fda.hhs.gov on or before 
August 7, 2015. If time permits, individuals or organizations that did 
not register in advance may be granted the opportunity to make a 
presentation.
    Persons registered to make an oral presentation are encouraged to 
arrive at the meeting room early and check in at the onsite 
registration table to confirm their designated presentation time. An 
agenda for the meeting and other background materials will be made 
available 3 days before the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm451529.htm. If you need special accommodations because of 
a disability, please contact Althea Cuff (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days before the meeting.
    Meeting Registration and Request to Present: The meeting is free 
and seating will be on a first-come, first-served basis. If you wish to 
attend or make an oral presentation, see section V.C. for information 
on how to register and the deadline for registration. If you cannot 
attend in person, information about how you can access a live Web cast 
will be located at http://www.fda.gov/Drugs/NewsEvents/ucm451529.htm.
    Transcripts: As soon as a transcript is available, it will be 
accessible at http://www.regulations.gov. It may also be viewed at the 
Division of Dockets Management (see ADDRESSES). A transcript will also 
be available in either hard copy or on CD-ROM, after submission of a 
Freedom of Information request. Send written requests to the Division 
of Freedom of Information (ELEM-1029), Food and Drug Administration, 
12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
    Streaming Web Cast of the Public Meeting: For those unable to 
attend in person, FDA will provide a live Web cast of the meeting. To 
join the meeting via the Web cast, please go to https://collaboration.fda.gov/qmpm2015/. An agenda will be posted on the FDA 
Web site at http://www.fda.gov/Drugs/NewsEvents/ucm451529.htm prior to 
the meeting.
    Docket Comments: Regardless of attendance at the public meeting, 
interested persons may submit either electronic or written comments 
regarding this document to the public docket (see ADDRESSES) by (see 
DATES). Given that time will be limited at the public meeting, FDA 
encourages all interested persons to comment in writing to ensure that 
their comments are considered.

VI. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: July 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18448 Filed 7-27-15; 8:45 am]
 BILLING CODE 4164-01-P