4164-01-P Food And Drug Administration
This document is scheduled to be published in theFederal Register on 03/28/2019 and available online athttps://federalregister.gov/d/2019-05803, and on govinfo.gov4164-01-PDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration21 CFR Part 900[Docket No. FDA-2013-N-0134]RIN 0910-AH04Mammography Quality Standards ActAGENCY: Food and Drug Administration, HHS.ACTION: Proposed rule.SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing to update themammography regulations that were issued under the Mammography Quality Standards Act of1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are proposingupdates to modernize the regulations by incorporating current science and mammography bestpractices. These updates would improve the delivery of mammography services bystrengthening the communication of healthcare information; allowing for more informeddecision making by patients and providers (by requiring facilities to provide them with additionalhealth information); helping to ensure the availability of qualified mammography personnel;bolstering the medical outcomes audit to provide feedback to improve mammographyinterpretations; modernizing technological aspects of the standards; and adding additional toolsto deal with noncompliant facilities.DATES: Submit either electronic or written comments on the proposed rule by [INSERT DATE90 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Submitcomments on information collection issues under the Paperwork Reduction Act of 1995 by
[INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERALREGISTER].ADDRESSES: You may submit comments as follows. Please note that late, untimely filedcomments will not be considered. Electronic comments must be submitted on or before[INSERT DATE 90 DAYS AFTER DATE OF PUBLICATION IN THE FEDERALREGISTER]. The https://www.regulations.gov electronic filing system will accept commentsuntil 11:59 p.m. Eastern Time at the end of [INSERT DATE 90 DAYS AFTER DATE OFPUBLICATION IN THE FEDERAL REGISTER]. Comments received by mail/handdelivery/courier (for written/paper submissions) will be considered timely if they are postmarkedor the delivery service acceptance receipt is on or before that date.Electronic SubmissionsSubmit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions forsubmitting comments. Comments submitted electronically, including attachments, tohttps://www.regulations.gov will be posted to the docket unchanged. Because yourcomment will be made public, you are solely responsible for ensuring that your commentdoes not include any confidential information that you or a third party may not wish to beposted, such as medical information, your or anyone else’s Social Security number, orconfidential business information, such as a manufacturing process. Please note that ifyou include your name, contact information, or other information that identifies you inthe body of your comments, that information will be posted onhttps://www.regulations.gov.
If you want to submit a comment with confidential information that you do not wish to bemade available to the public, submit the comment as a written/paper submission and inthe manner detailed (see “Written/Paper Submissions” and “Instructions”).Written/Paper SubmissionsSubmit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will postyour comment, as well as any attachments, except for information submitted, marked andidentified as confidential, if submitted as detailed in “Instructions.”Instructions: All submissions received must include the Docket No. FDA-2013-N-0134for “Mammography Quality Standards Act; Amendments to Part 900 Regulations.” Receivedcomments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and,except for those submitted as “Confidential Submissions,” publicly viewable athttps://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m.,Monday through Friday. Confidential Submissions--To submit a comment with confidential information that youdo not wish to be made publicly available, submit your comments only as a written/papersubmission. You should submit two copies total. One copy will include the informationyou claim to be confidential with a heading or cover note that states “THIS DOCUMENTCONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy,including the claimed confidential information, in its consideration of comments. The
second copy, which will have the claimed confidential information redacted/blacked out,will be available for public viewing and posted on https://www.regulations.gov. Submitboth copies to the Dockets Management Staff. If you do not wish your name and contactinformation to be made publicly available, you can provide this information on the coversheet 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 inaccordance with 21 CFR 10.20 and other applicable disclosure law. For moreinformation about FDA’s posting of comments to public dockets, see 80 FR 56469,September 18, 2015, or access the information at: 5-23389.pdf.Docket: For access to the docket to read background documents or the electronic andwritten/paper comments received, go to http://www.regulations.gov and insert the docketnumber, found in brackets in the heading of this document, into the “Search” box and follow theprompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,MD 20852.Submit comments on information collection issues under the Paperwork Reduction Actof 1995 to the Office of Management and Budget (OMB) in the following ways: Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,Fax: 202-395-7285, or email to oira submission@omb.eop.gov. All comments should beidentified with the title, Mammography Quality Standards Act; Amendments to Part 900Regulations.FOR FURTHER INFORMATION CONTACT: Preetham Sudhaker, Division of MammographyQuality Standards (DMQS), Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-7965911.SUPPLEMENTARY INFORMATION:Table of ContentsI.Executive SummaryA.Purpose of the Proposed RuleB.Legal AuthorityC.Summary of the Major Provisions of the Proposed RuleD.Costs and Benefits of the Proposed RuleII.Table of Abbreviations and Acronyms Commonly Used in This DocumentIII.BackgroundA. FDA’s Current Regulatory Framework for MammographyB. History of FDA’s Mammography Regulations (21 CFR Part 900)C. Need for New and Amended RegulationsIV.Legal AuthorityV.Description of the Proposed RuleA. Definitions of Mammography and Mammographic ModalityB. Repeated Failure of AccreditationC. Retention and Provision of Personnel RecordsD. Equipment and Quality ControlE. Mammography ReportingF. RecordkeepingG. Mammography Medical Outcomes Audit
H. Additional Mammography Review and Patient and Referring Physician NotificationI. Additional Bases for Suspension or Revocation of a Certificate, and Ineligibility toOwn or Operate After RevocationVI.Proposed Effective DateVII.Preliminary Economic Analysis of ImpactsVIII.Analysis of Environmental ImpactIX.Paperwork Reduction Act of 1995X.FederalismXI.ReferencesI.A.Executive SummaryPurpose of the Proposed RuleMammography is an x-ray imaging examination used to identify signs of breast cancer.For women to receive the full benefit of mammography, the service must be of high quality,including performance of the examination by qualified technologists; using equipment that istested and properly functioning; interpretation by qualified physicians; and clear and promptcommunication of results to patients and their referring healthcare providers. The MQSAestablishes uniform baseline Federal standards designed to ensure that all women nationwidehave access to quality mammography services, and its implementing regulations addressstandards for accreditation bodies and certifying agencies, qualifications of personnel atmammography facilities, standards for mammography equipment, quality assurance testing,recordkeeping, and communication of results. Based on technology changes in mammographyand our experience with the administration of the MQSA program, FDA is proposing tomodernize and improve the regulations as well as improve the information, including breast
density information, provided by mammography facilities to patients and their healthcareproviders. The proposed changes would require that the lay summary provided to patientsidentify whether the patient has low or high density breasts and include a prescribed paragraphon the significance of breast density. They would also establish four categories for reportingbreast tissue density in the mammography report that is provided to the patient’s referringhealthcare provider.B. Legal AuthorityThe MQSA (Pub. L. 102-539) was enacted on October 27, 1992, and is codified underthe Public Health Service (PHS) Act (42 U.S.C. 263b; section 354 of the PHS Act). Under theMQSA, all mammography facilities, except facilities of the Department of Veteran Affairs (VA),must be accredited by an approved accreditation body and certified by FDA (or an approvedState certification agency) to provide mammography services (42 U.S.C. 263b(b)(1), (d)(1)(iv)).FDA is proposing these amendments to the mammography regulations (set forth in part 900 (21CFR part 900)) under section 354 of the PHS Act (42 U.S.C. 263b), and sections of the FD&CAct (sections 519, 537, and 704(e); 21 U.S.C. 360i, 360nn, and 374(e)).C. Summary of the Major Provisions of the Proposed RuleFDA is proposing three categories of improvements to our mammography regulations :improvements that address changes in mammography technology; improvements that enhanceenforcement of quality standards; and improvements in the way mammo graphy results arecategorized, reported, retained, and transferred to patients and healthcare providers. New and amended proposed provisions related to technology would, among other things,update several equipment and quality control provisions in the regulations to addresscurrent technology, including digital mammography.
Improvements that enhance enforcement would, among other things:oRequire that mammograms submitted for interpretation be presented in themammographic modality in which they were originally produced, and not becopied or digitized, which could adversely affect the accuracy of interpretation;o Prohibit accreditation bodies from accepting an application for accreditation froma facility that has failed to become accredited after three consecutive attemptsuntil 1 year after the most recent accreditation failure;oExpressly state that a facility’s certificate may be suspended or revoked due to afailure to comply with reasonable requests by FDA, the State certification agency,or the accreditation body for records, including clinical images for an additionalmammography review (AMR), or with reasonable requests by current or formerfacility personnel for records documenting their qualifications;o Add the State certification agency as an entity that may initiate an AMR, whichcan help detect quality issues, and also to state expressly that FDA and the Statecertification agency can notify patients and their providers individually or throughthe mass media when a facility is unable or unwilling to perform a requiredpatient and referring physician notification (PPN), which would help to ensurethat patients and providers are informed of serious risks to human health resultingfrom mammography that fails to meet quality standards;o Require that, before a facility closes or no longer provides mammographyservices, it must make arrangements for access by patients and healthcareproviders to mammography images and reports; and
o Require facilities to provide personnel with copies of their MQSA qualificationrecords, which are often needed to work at additional or new facilities. Improvements in the way mammography results are categorized, reported, retained,and transferred to patients and healthcare providers would, among other things:o Require that the mammographic examination report include the facility name andlocation (at a minimum, the city, State, and ZIP code of the facility), in order tohelp to ensure that healthcare providers can obtain the necessary information toenable them to assist women in making informed healthcare decisions;o Change the explanatory language in one final assessment category (“benign”) topromote greater consistency and accuracy in the use of the category, and add threenew categories of mammographic assessment to the existing categories in theregulations, which would allow mammography facilities to more preciselyclassify and communicate findings;o Add a specific, required timeframe for facilities to deliver medical reports tohealthcare providers and the summary written in lay language to patients whosemammograms have either “Suspicious” or “Highly suggestive of malignancy”final assessment categories, which could lead to earlier definitive tissue diagnosisof malignancy and earlier start of treatment, and avoid, for the patient, the anxietyof a protracted waiting period;o Require reporting to patients and healthcare providers to include an assessment ofbreast density, in order to provide them with additional information about theirmammography and the potential limitations of their mammogram results so theyand their healthcare providers can make informed healthcare decisions;
o Require each mammography facility to implement policies and procedures tominimize the loss of mammography images and reports because the loss of theserecords can have a significant, negative impact on clinical care, and also specifythe timeframe within which facilities must transfer original mammograms andcopies of reports to patients, healthcare providers, and others because delays inthe transfer of these records can lead to delays in diagnosis or treatment; ando Clarify the minimum information that facilities must collect during themammography medical outcomes audit because calculating and tracking thesevalues is important to the evaluation of accuracy in detecting breast cancer,allowing facilities and interpreting physicians to review their performance andenact quality improvement measures.D. Costs and Benefits of the Proposed RuleThe primary public health benefits of the proposed rule come from the potential forearlier breast cancer detection, improved morbidity and mortality, resulting in reductions incancer treatment costs.The quantified benefits are derived from reduced mortality and breast cancer treatmentcosts resulting from the breast density reporting requirements. The estimate of annualizedbenefits over 10 years ranges from 16.27 million to 466.75 million at a 7 percent discount rateand 16.27 million to 534.03 million at a 3 percent discount rate. The costs of the proposedrule include costs to mammography facilities to comply with the proposed requirements andcosts associated with supplemental testing and biopsies resulting from the breast densityrequirements. The estimate of annualized costs over 10 years ranges from 34.96 million to 60.50 million at a 7 percent discount rate with a primary value of 47.03 million. Using a 3
percent discount rate, the annualized costs range from 33.86 million to 59.40 million with aprimary value of 45.92 million. The primary estimate of the present value of costs over 10years is 330.29 million at a 7 percent discount rate and 391.74 million at a 3 percent discountrate.II. Table of Abbreviations and Acronyms Commonly Used in This DocumentAmerican College of RadiologyACRCenters for Disease Control and PreventionCDCConference of Radiation Control ProgramCRCPDDirectors, Inc.Division of Mammography Quality Standards DMQSFood and Drug AdministrationFDA or weFederal Food, Drug, and Cosmetic ActFD&C ActInstitute of MedicineIOMMammography Quality Standards Act ofMQSA1992Mammography Quality StandardsMQSRAReauthorization Acts of 1998 and 2004National Mammography Quality AssuranceNMQAACAdvisory CommitteePublic Health Service ActPHS ActIII. BackgroundAccording to the Centers for Disease Control and Prevention (CDC), in 2014, the mostrecent year for which numbers are available, over 235,000 women were diagnosed with breastcancer, and more than 41,000 women died of the disease (Ref. 1). According to the NationalCancer Institute of the National Institutes of Health, in 2017, over 250,000 women wereprojected to be diagnosed with breast cancer, and over 40,000 women were projected to die ofthe disease (Ref. 2). Among women, breast cancer is now the most common non-skin cancerand the second leading cause of cancer deaths after lung cancer (Ref. 3). Early detection ofbreast cancer, typically involving breast physical examination and mammography, is the bestmeans of preventing deaths that can result if the diagnosis is delayed until the onset of more
advanced symptoms (Ref. 4). Mammography is a type of medical imaging that uses x-rays tocreate images (mammograms) of the internal structures of the breasts. There are three types ofmammography referred to in this document: screen-film mammography, full field digitalmammography, and digital breast tomosynthesis. In screen-film mammography, x-rays aretransmitted through the breast and expose a sheet of x-ray film enclosed in a cassette. In fullfield digital mammography, the x-rays go through to an image receptor that is a radiationsensitive electronic device or plate. Images are displayed on a computer work station, and can,for example, be digitally magnified. Digital breast tomosynthesis also uses an electronic imagereceptor and a computer work station, and obtains multiple images at different angles around thebreast, then uses a computer to reconstruct a series of parallel images that resemble slicesthrough the breast.Mammography can help detect breast cancer in its earliest, most treatable stages, when itis too small to be felt or detected by any other method (Ref. 5).However, as noted by the Government Accountability Office (GAO), a mammogram isamong the most difficult radiographic images to interpret (Ref. 6). The mammogram must be ofhigh quality for accurate image interpretation. If the image quality is poor, the interpreter maymiss a cancerous lesion. Such a false negative diagnosis could delay treatment and result in anavoidable death or increased morbidity. It is equally true that poor quality images or inaccurateinterpretations can lead to a false positive diagnosis when normal tissue is misinterpreted asabnormal. This could lead to needless anxiety for the patient, costly additional testing, andunnecessary biopsies.A. FDA’s Current Regulatory Framework for Mammography
The MQSA was enacted on October 27, 1992. The passage of the MQSA came after theSenate Committee on Labor and Human Resources held hearings on breast cancer and found awide range of problems with mammography practice in the United States, including poor qualityequipment, a lack of quality assurance (QA) procedures, poorly trained radiologic technologistsand interpreting physicians, and a lack of facility inspections and consistent governmentaloversight (Refs. 7 and 8). Under the MQSA, a comprehensive statutory scheme for thecertification and inspection of mammography facilities was established to ensure that only thosefacilities that comply with Federal standards of safety and quality could continue to operate afterOc
Food and Drug Administration 21 CFR Part 900 [Docket No. FDA-2013-N-0134] RIN 0910-AH04 Mammography Quality Standards Act AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: Th
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