Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11669

Dockets Management Staff between 9 yellow prussiate of soda as an patients and providers (by requiring a.m. and 4 p.m., Monday through anticaking agent for potassium chloride facilities to provide them with Friday. in animal food. additional health information); helping • Confidential Submissions—To We are reviewing the potential to ensure the availability of qualified submit a comment with confidential environmental impact of this petition. mammography personnel; bolstering the information that you do not wish to be To encourage public participation medical outcomes audit to provide made publicly available, submit your consistent with regulations issued under feedback to improve mammography comments only as a written/paper the National Environmental Policy Act interpretations; modernizing submission. You should submit two (40 CFR 1501.4(b)), we are placing the technological aspects of the standards; copies total. One copy will include the environmental assessment submitted and adding additional tools to deal with information you claim to be confidential with the petition that is the subject of noncompliant facilities. with a heading or cover note that states this notice on public display at the DATES: Submit either electronic or ‘‘THIS DOCUMENT CONTAINS Dockets Management Staff (see DATES written comments on the proposed rule CONFIDENTIAL INFORMATION.’’ The and ADDRESSES) for public view and by June 26, 2019. Submit comments on Agency will review this copy, including comment. information collection issues under the the claimed confidential information, in We will also place on public display, Paperwork Reduction Act of 1995 by its consideration of comments. The at the Dockets Management Staff and at April 29, 2019. second copy, which will have the https://www.regulations.gov, any ADDRESSES: You may submit comments claimed confidential information amendments to, or comments on, the as follows. Please note that late, redacted/blacked out, will be available petitioner’s environmental assessment untimely filed comments will not be for public viewing and posted on without further announcement in the considered. Electronic comments must https://www.regulations.gov. Submit Federal Register. If, based on our be submitted on or before June 26, 2019. both copies to the Dockets Management review, we find that an environmental The https://www.regulations.gov Staff. If you do not wish your name and impact statement is not required, and electronic filing system will accept contact information to be made publicly this petition results in a regulation, we comments until 11:59 p.m. Eastern Time available, you can provide this will publish the notice of availability of at the end of June 26, 2019. Comments information on the cover sheet and not our finding of no significant impact and received by mail/hand delivery/courier in the body of your comments and you the evidence supporting that finding (for written/paper submissions) will be must identify this information as with the regulation in the Federal considered timely if they are ‘‘confidential.’’ Any information marked Register in accordance with 21 CFR postmarked or the delivery service as ‘‘confidential’’ will not be disclosed 25.51(b). acceptance receipt is on or before that except in accordance with 21 CFR 10.20 Dated: March 22, 2019. date. and other applicable disclosure law. For Lowell J. Schiller, Electronic Submissions more information about FDA’s posting Acting Associate Commissioner for Policy. of comments to public dockets, see 80 Submit electronic comments in the FR 56469, September 18, 2015, or access [FR Doc. 2019–05954 Filed 3–27–19; 8:45 am] BILLING CODE 4164–01–P following way: the information at: https://www.gpo.gov/ • Federal eRulemaking Portal: fdsys/pkg/FR-2015-09-18/pdf/2015- https://www.regulations.gov. Follow the 23389.pdf. DEPARTMENT OF HEALTH AND instructions for submitting comments. Docket: For access to the docket to HUMAN SERVICES Comments submitted electronically, read background documents or the including attachments, to https:// electronic and written/paper comments Food and Drug Administration www.regulations.gov will be posted to received, go to https:// the docket unchanged. Because your www.regulations.gov and insert the 21 CFR Part 900 comment will be made public, you are docket number, found in brackets in the [Docket No. FDA–2013–N–0134] solely responsible for ensuring that your heading of this document, into the comment does not include any ‘‘Search’’ box and follow the prompts RIN 0910–AH04 confidential information that you or a and/or go to the Dockets Management third party may not wish to be posted, Mammography Quality Standards Act Staff, 5630 Fishers Lane, Rm. 1061, such as medical information, your or Rockville, MD 20852. AGENCY: Food and Drug Administration, anyone else’s Social Security number, or FOR FURTHER INFORMATION CONTACT: HHS. confidential business information, such Chelsea Trull, Center for Veterinary ACTION: Proposed rule. as a manufacturing process. Please note Medicine, Food and Drug that if you include your name, contact Administration, 7519 Standish Pl., SUMMARY: The Food and Drug information, or other information that Rockville, MD 20855, 240–402–6729, Administration (FDA or Agency) is identifies you in the body of your [email protected]. proposing to update the mammography comments, that information will be SUPPLEMENTARY INFORMATION: Under the regulations that were issued under the posted on https://www.regulations.gov. Federal Food, Drug, and Cosmetic Act Mammography Quality Standards Act of • If you want to submit a comment (section 409(b)(5) (21 U.S.C. 348(b)(5))), 1992 (MQSA) and the Federal Food, with confidential information that you we are giving notice that we have filed Drug, and Cosmetic Act (FD&C Act). We do not wish to be made available to the a food additive petition (FAP 2307), are proposing updates to modernize the public, submit the comment as a submitted by Uralkali PSJ, Ul., regulations by incorporating current written/paper submission and in the Pyatiletki 63, Berezniki, Perm Territory, science and mammography best manner detailed (see ‘‘Written/Paper 618426, Russia. The petition proposes to practices. These updates would improve Submissions’’ and ‘‘Instructions’’). amend the food additive regulations in the delivery of mammography services 21 CFR part 573 Food Additives by strengthening the communication of Written/Paper Submissions Permitted in Feed and Drinking Water of healthcare information; allowing for Submit written/paper submissions as Animals to provide for the safe use of more informed decision making by follows:

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11670 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

• Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts I. Executive Summary written/paper submissions): Dockets and/or go to the Dockets Management A. Purpose of the Proposed Rule Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, Drug Administration, 5630 Fishers Rockville, MD 20852. Mammography is an x-ray imaging examination used to identify signs of Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information • breast cancer. For women to receive the For written/paper comments collection issues under the Paperwork full benefit of mammography, the submitted to the Dockets Management Reduction Act of 1995 to the Office of Staff, FDA will post your comment, as service must be of high quality, Management and Budget (OMB) in the well as any attachments, except for including performance of the following ways: information submitted, marked and examination by qualified technologists; identified as confidential, if submitted • Fax to the Office of Information and using equipment that is tested and as detailed in ‘‘Instructions.’’ Regulatory Affairs, OMB, Attn: FDA properly functioning; interpretation by Instructions: All submissions received Desk Officer, Fax: 202–395–7285, or qualified physicians; and clear and must include the Docket No. FDA– email to [email protected]. prompt communication of results to 2013–N–0134 for ‘‘Mammography All comments should be identified with patients and their referring healthcare Quality Standards Act; Amendments to the title, Mammography Quality providers. The MQSA establishes Part 900 Regulations.’’ Received Standards Act; Amendments to Part 900 uniform baseline Federal standards comments, those filed in a timely Regulations. designed to ensure that all women manner (see ADDRESSES), will be placed nationwide have access to quality FOR FURTHER INFORMATION CONTACT: in the docket and, except for those mammography services, and its Preetham Sudhaker, Division of submitted as ‘‘Confidential implementing regulations address Mammography Quality Standards Submissions,’’ publicly viewable at standards for accreditation bodies and (DMQS), Center for Devices and https://www.regulations.gov or at the certifying agencies, qualifications of Radiological Health, Food and Drug Dockets Management Staff between 9 personnel at mammography facilities, Administration, 10903 New Hampshire a.m. and 4 p.m., Monday through standards for mammography equipment, Ave., Bldg. 66, Silver Spring, MD 20993, Friday. quality assurance testing, • Confidential Submissions—To 301–796–5911. recordkeeping, and communication of submit a comment with confidential SUPPLEMENTARY INFORMATION: results. Based on technology changes in information that you do not wish to be mammography and our experience with made publicly available, submit your Table of Contents the administration of the MQSA comments only as a written/paper I. Executive Summary program, FDA is proposing to submission. You should submit two A. Purpose of the Proposed Rule modernize and improve the regulations copies total. One copy will include the B. Legal Authority as well as improve the information, information you claim to be confidential C. Summary of the Major Provisions of the including breast density information, with a heading or cover note that states Proposed Rule provided by mammography facilities to ‘‘THIS DOCUMENT CONTAINS D. Costs and Benefits of the Proposed Rule patients and their healthcare providers. CONFIDENTIAL INFORMATION.’’ The II. Table of Abbreviations and Acronyms The proposed changes would require Agency will review this copy, including Commonly Used in This Document that the lay summary provided to the claimed confidential information, in III. Background patients identify whether the patient has its consideration of comments. The A. FDA’s Current Regulatory Framework low or high density breasts and include second copy, which will have the for Mammography a prescribed paragraph on the claimed confidential information B. History of FDA’s Mammography significance of breast density. They redacted/blacked out, will be available Regulations (21 CFR Part 900) would also establish four categories for for public viewing and posted on C. Need for New and Amended Regulations reporting breast tissue density in the https://www.regulations.gov. Submit IV. Legal Authority mammography report that is provided to both copies to the Dockets Management V. Description of the Proposed Rule the patient’s referring healthcare Staff. If you do not wish your name and A. Definitions of Mammography and provider. contact information to be made publicly Mammographic Modality available, you can provide this B. Repeated Failure of Accreditation B. Legal Authority information on the cover sheet and not C. Retention and Provision of Personnel The MQSA (Pub. L. 102–539) was in the body of your comments and you Records enacted on October 27, 1992, and is must identify this information as D. Equipment and Quality Control codified under the Public Health ‘‘confidential.’’ Any information marked E. Mammography Reporting Service (PHS) Act (42 U.S.C. 263b; as ‘‘confidential’’ will not be disclosed F. Recordkeeping section 354 of the PHS Act). Under the G. Mammography Medical Outcomes except in accordance with 21 CFR 10.20 MQSA, all mammography facilities, Audit and other applicable disclosure law. For except facilities of the Department of H. Additional Mammography Review and Veteran Affairs (VA), must be accredited more information about FDA’s posting Patient and Referring Physician by an approved accreditation body and of comments to public dockets, see 80 Notification FR 56469, September 18, 2015, or access I. Additional Bases for Suspension or certified by FDA (or an approved State the information at: https://www.gpo.gov/ Revocation of a Certificate, and certification agency) to provide fdsys/pkg/FR-2015-09-18/pdf/2015- Ineligibility To Own or Operate After mammography services (42 U.S.C. 23389.pdf. Revocation 263b(b)(1), (d)(1)(iv)). FDA is proposing Docket: For access to the docket to VI. Proposed Effective Date these amendments to the mammography read background documents or the VII. Preliminary Economic Analysis of regulations (set forth in part 900 (21 electronic and written/paper comments Impacts CFR part 900)) under section 354 of the received, go to http:// VIII. Analysis of Environmental Impact PHS Act (42 U.S.C. 263b), and sections www.regulations.gov and insert the IX. Paperwork Reduction Act of 1995 of the FD&C Act (sections 519, 537, and docket number, found in brackets in the X. Federalism 704(e); 21 U.S.C. 360i, 360nn, and heading of this document, into the XI. References 374(e)).

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11671

C. Summary of the Major Provisions of qualification records, which are often physicians to review their performance the Proposed Rule needed to work at additional or new and enact quality improvement FDA is proposing three categories of facilities. measures. • Improvements in the way improvements to our mammography mammography results are categorized, D. Costs and Benefits of the Proposed regulations: Improvements that address reported, retained, and transferred to Rule changes in mammography technology; patients and healthcare providers improvements that enhance The primary public health benefits of would, among other things: enforcement of quality standards; and Æ Require that the mammographic the proposed rule come from the improvements in the way examination report include the facility potential for earlier breast cancer mammography results are categorized, name and location (at a minimum, the detection, improved morbidity and reported, retained, and transferred to city, State, and ZIP code of the facility), mortality, resulting in reductions in patients and healthcare providers. cancer treatment costs. • in order to help to ensure that New and amended proposed healthcare providers can obtain the The quantified benefits are derived provisions related to technology would, necessary information to enable them to from reduced mortality and breast among other things, update several assist women in making informed cancer treatment costs resulting from equipment and quality control healthcare decisions; the breast density reporting provisions in the regulations to address Æ Change the explanatory language in requirements. The estimate of current technology, including digital one final assessment category annualized benefits over 10 years ranges mammography. (‘‘benign’’) to promote greater • from $16.27 million to $466.75 million Improvements that enhance consistency and accuracy in the use of at a 7 percent discount rate and $16.27 enforcement would, among other things: the category, and add three new Æ million to $534.03 million at a 3 percent Require that mammograms categories of mammographic assessment discount rate. The costs of the proposed submitted for interpretation be to the existing categories in the rule include costs to mammography presented in the mammographic regulations, which would allow facilities to comply with the proposed modality in which they were originally mammography facilities to more requirements and costs associated with produced, and not be copied or precisely classify and communicate supplemental testing and biopsies digitized, which could adversely affect findings; resulting from the breast density the accuracy of interpretation; Æ Add a specific, required timeframe Æ requirements. The estimate of Prohibit accreditation bodies from for facilities to deliver medical reports annualized costs over 10 years ranges accepting an application for to healthcare providers and the from $34.96 million to $60.50 million at accreditation from a facility that has summary written in lay language to a 7 percent discount rate with a primary failed to become accredited after three patients whose mammograms have value of $47.03 million. Using a 3 consecutive attempts until 1 year after either ‘‘Suspicious’’ or ‘‘Highly percent discount rate, the annualized the most recent accreditation failure; suggestive of malignancy’’ final costs range from $33.86 million to Æ Expressly state that a facility’s assessment categories, which could lead $59.40 million with a primary value of certificate may be suspended or revoked to earlier definitive tissue diagnosis of $45.92 million. The primary estimate of due to a failure to comply with malignancy and earlier start of the present value of costs over 10 years reasonable requests by FDA, the State treatment, and avoid, for the patient, the is $330.29 million at a 7 percent certification agency, or the accreditation anxiety of a protracted waiting period; discount rate and $391.74 million at a body for records, including clinical Æ Require reporting to patients and 3 percent discount rate. images for an additional mammography healthcare providers to include an review (AMR), or with reasonable assessment of breast density, in order to II. TABLE OF ABBREVIATIONS AND requests by current or former facility provide them with additional ACRONYMS COMMONLY USED IN personnel for records documenting their information about their mammography qualifications; and the potential limitations of their THIS DOCUMENT Æ Add the State certification agency mammogram results so they and their as an entity that may initiate an AMR, healthcare providers can make informed which can help detect quality issues, healthcare decisions; and also to state expressly that FDA and Æ American College of Radi- ACR. Require each mammography ology. the State certification agency can notify facility to implement policies and Centers for Disease Control CDC. patients and their providers procedures to minimize the loss of and Prevention. individually or through the mass media mammography images and reports Conference of Radiation Con- CRCPD. when a facility is unable or unwilling to because the loss of these records can trol Program Directors, Inc. perform a required patient and referring have a significant, negative impact on Division of Mammography DMQS. physician notification (PPN), which clinical care, and also specify the Quality Standards. would help to ensure that patients and timeframe within which facilities must Food and Drug Administration FDA or we. providers are informed of serious risks transfer original mammograms and Federal Food, Drug, and Cos- FD&C Act. to human health resulting from copies of reports to patients, healthcare metic Act. mammography that fails to meet quality providers, and others because delays in Institute of Medicine ...... IOM. standards; the transfer of these records can lead to Mammography Quality Stand- MQSA. Æ Require that, before a facility closes delays in diagnosis or treatment; and ards Act of 1992. or no longer provides mammography Æ Clarify the minimum information Mammography Quality Stand- MQSRA. services, it must make arrangements for that facilities must collect during the ards Reauthorization Acts access by patients and healthcare mammography medical outcomes audit of 1998 and 2004. providers to mammography images and because calculating and tracking these National Mammography Qual- NMQAAC. ity Assurance Advisory reports; and values is important to the evaluation of Æ Committee. Require facilities to provide accuracy in detecting breast cancer, Public Health Service Act ...... PHS Act. personnel with copies of their MQSA allowing facilities and interpreting

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11672 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

III. Background lead to needless anxiety for the patient, activities (see 42 U.S.C. 263b(e)(1) and According to the Centers for Disease costly additional testing, and (3)). The MQSA also requires that, as Control and Prevention (CDC), in 2014, unnecessary biopsies. part of the overall accreditation process, actual clinical mammograms from each the most recent year for which numbers A. FDA’s Current Regulatory Framework facility be evaluated for quality by the are available, over 235,000 women were for Mammography accreditation body (see 42 U.S.C. diagnosed with breast cancer, and more The MQSA was enacted on October than 41,000 women died of the disease 263b(e)(1)(B)(i)). 27, 1992. The passage of the MQSA 2. An annual mammography facility (Ref. 1). According to the National came after the Senate Committee on physics survey, consultation, and Cancer Institute of the National Labor and Human Resources held evaluation performed by a qualified Institutes of Health, in 2017, over hearings on breast cancer and found a medical physicist (see 42 U.S.C. 250,000 women were projected to be wide range of problems with 263b(e)(1)(B)(iv)). diagnosed with breast cancer, and over mammography practice in the United 3. Annual inspection of 40,000 women were projected to die of States, including poor quality mammography facilities, to be the disease (Ref. 2). Among women, equipment, a lack of quality assurance performed by FDA-certified Federal or breast cancer is now the most common (QA) procedures, poorly trained State inspectors (see 42 U.S.C. non-skin cancer and the second leading radiologic technologists and interpreting 263b(g)(1)(E)). If State inspectors are cause of cancer deaths after lung cancer physicians, and a lack of facility used, the MQSA requires a Federal (Ref. 3). Early detection of breast cancer, inspections and consistent audit of the State inspection program by typically involving breast physical governmental oversight (Refs. 7 and 8). direct Federal inspections of a sample of examination and mammography, is the Under the MQSA, a comprehensive State-inspected facilities (see 42 U.S.C. best means of preventing deaths that can statutory scheme for the certification 263b(g)(3)). result if the diagnosis is delayed until and inspection of mammography 4. Establishment of initial and the onset of more advanced symptoms facilities was established to ensure that continuing qualification standards for (Ref. 4). Mammography is a type of only those facilities that comply with interpreting physicians, radiologic medical imaging that uses x-rays to Federal standards of safety and quality technologists, medical physicists, and create images (mammograms) of the could continue to operate after October mammography facility inspectors (see internal structures of the breasts. There 1, 1994. Operation after that date is 42 U.S.C. 263b(f)(1)(C)–(E) and are three types of mammography contingent on receipt of an FDA (g)(1)(D)). referred to in this document: Screen- certificate attesting that the facility 5. Specification of boards or film mammography, full field digital meets the mammography quality organizations eligible to certify the mammography, and digital breast standards. All mammography facilities adequacy of training and experience of tomosynthesis. In screen-film are subject to the MQSA, except for mammography personnel (see 42 U.S.C. mammography, x-rays are transmitted those under the jurisdiction of the VA. 263b(f)(2)). through the breast and expose a sheet of All covered facilities have to meet 6. Establishment of quality standards x-ray film enclosed in a cassette. In full baseline standards in the areas of for mammography equipment and field digital mammography, the x-rays radiation dose, equipment, and practices, including QA and quality go through to an image receptor that is personnel, and other general practices, control programs (see 42 U.S.C. a radiation-sensitive electronic device or such as quality control and quality 263b(f)(1)(A)). plate. Images are displayed on a assurance, are required to be accredited 7. Standards governing recordkeeping computer work station, and can, for by an approved accreditation body and for patient files and requirements for example, be digitally magnified. Digital certified by the Secretary of Health and mammography reporting and patient breast tomosynthesis also uses an Human Services (the Secretary) (42 notification by physicians (see 42 U.S.C. electronic image receptor and a U.S.C. 263b(b)(1) and (d)(1)(A)(iv)). 263b(f)(1)(G)). computer work station, and obtains Facilities must also undergo annual 8. Establishment of the National multiple images at different angles inspections to ensure compliance with Mammography Quality Assurance around the breast, then uses a computer the MQSA requirements (42 U.S.C Advisory Committee (NMQAAC or to reconstruct a series of parallel images 263b(g)(1)). The MQSA also provides for Committee) (see 42 U.S.C. 263b(n)(1)). that resemble slices through the breast. oversight and enforcement to help to Among other things, NMQAAC is Mammography can help detect breast ensure that mammography services required to advise FDA on appropriate cancer in its earliest, most treatable meet these Federal quality standards (42 quality standards for mammography stages, when it is too small to be felt or U.S.C. 263b(h), (i), and (j)). facilities and accreditation bodies (see detected by any other method (Ref. 5). The Mammography Quality Standards 42 U.S.C. 263b(n)(3)). However, as noted by the Government Reauthorization Acts of 1998 and 2004 B. History of FDA’s Mammography Accountability Office (GAO), a (MQSRA) (Pub. L. 105–248 and 108– Regulations (21 CFR Part 900) mammogram is among the most difficult 365) amended the MQSA by, among radiographic images to interpret (Ref. 6). other things, enhancing patient FDA published interim The mammogram must be of high notification concerning health risks and mammography regulations on December quality for accurate image clarifying the types of certificates that 21, 1993 (58 FR 67558 and 58 FR 67565; interpretation. If the image quality is could be issued under the MQSA. see also 59 FR 49808). These interim poor, the interpreter may miss a Specifically, the MQSA requires the regulations established requirements for cancerous lesion. Such a false negative following: entities applying to serve as diagnosis could delay treatment and 1. Accreditation of mammography accreditation bodies and for facilities result in an avoidable death or increased facilities by private, nonprofit applying to obtain FDA certification to morbidity. It is equally true that poor organizations or State agencies that have provide mammography services after quality images or inaccurate been approved by FDA as meeting the October 1, 1994. FDA published interpretations can lead to a false standards established by FDA for comprehensive mammography quality positive diagnosis when normal tissue is accreditation bodies and that continue standards in a final rule published on misinterpreted as abnormal. This could to pass annual FDA reviews of their October 28, 1997 (62 FR 55852). Most of

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11673

these regulations became effective on to the MQSA regulations. At the suspicious, and highly suggestive of April 28, 1999; the remainder became meeting, FDA sought input from the malignancy (see § 900.12(c)(1)(iv)(A)– effective on October 28, 2002. FDA also Committee on the potential inclusion of (E)), or the assessment ‘‘incomplete: published a final rule on the MQSA and breast tissue density information in need additional imaging evaluation’’ State certification agencies on February facility mammography reports. The (see § 900.12(c)(1)(v)). FDA is proposing 6, 2002 (67 FR 5446). Committee advised that FDA require to add to the current categories two new breast density reporting in C. Need for New and Amended categories of final assessment (known mammography reports provided to Regulations biopsy proven malignancy and post- healthcare providers as well as in lay- procedure mammograms for marker Most of the requirements in our language summaries provided to placement), and one new assessment mammography regulations are over 20 patients (Ref. 20). category of incomplete (need prior years old. As described below, major The MQSA and current regulations mammograms for comparison). The developments in understanding relating require a mammography facility to addition of these categories would allow to the importance of certain breast provide a written report on each the mammography facility to more anatomy on breast cancer risk have mammographic examination to the precisely classify its findings (see occurred and FDA believes these patient’s healthcare provider (see 42 section V.E.3 of this proposed rule and developments should be reflected in our U.S.C. 263b(f)(1)(G)(ii)(II); § 900.12(c)(3) proposed § 900.12(c)(1)). In September nationwide standard. In addition, we (21 CFR 900.12(c)(3)). The 2006, the NMQAAC recommended are proposing to update our mammography facility is also required adding these categories to the mammography regulations in response to provide a summary of the report in assessment categories used in the to several gaps that we have identified lay language to the patient (see 42 referring healthcare provider report (Ref. as we have implemented the current U.S.C. 263b(f)(1)(G)(ii)(IV); 22). regulations. For example, FDA is § 900.12(c)(2)). Current regulations do proposing to require that both the not require that a notification of breast IV. Legal Authority mammography report and lay summary density be part of the report provided to The MQSA (Pub. L. 102–539) was include basic mammography facility the healthcare provider or the lay enacted on October 27, 1992, and is identification information. Technology summary provided to the patient. codified at 42 U.S.C. 263b (section 354 has also advanced since the regulations However, there is increasing interest in of the PHS Act). Under the MQSA, all were promulgated, so the proposed breast density reporting, and States are mammography facilities, except regulations would make changes to taking action. Between 2009 and May facilities of the VA, must be accredited reflect current mammography best 2018, 34 States have passed laws by an approved accreditation body and practices and technologies. mandating notification of breast density certified by FDA (or an approved State 1. Additional Information in (Ref. 21). These State laws impose certification agency) to provide Mammography Reporting: Breast requirements that vary from State to mammography services (42 U.S.C. Density State. To ensure all women receive 263b(b)(1) and (d)(1)(iv)). FDA is consistent breast density information Breast density refers to the proportion proposing these amendments to the from their mammograms, FDA is mammography regulations (set forth in of fibroglandular tissue in the breast, as proposing to amend the mammography seen on a mammogram. Mammograms part 900) under section 354 of the PHS reporting requirements in § 900.12(c) to Act (42 U.S.C. 263b), and sections 519, of breasts with higher density are harder require that the written report of the to interpret than those of less dense 537, and 704(e) of the FD&C Act (21 results of the mammographic U.S.C. 360i, 360nn, and 374(e)). breasts, because the dense tissue can examination provided to the healthcare obscure cancers (Ref. 9). In 2005, the provider and the lay summary of the V. Description of the Proposed Rule Institute of Medicine (IOM) noted that results provided to the patient also breast density is a characteristic of some A. Definitions of Mammography and include information concerning patient Mammographic Modality patients that affects the quality of breast density. mammographic interpretation (Ref. 10). FDA is proposing to amend the In addition, since the publication of the 2. Classifications of Mammography definition of ‘‘mammography’’ to current MQSA regulations, peer Assessment exclude computed tomography (CT) of reviewed scientific research has Additionally, the current categories the breast as the requirements in part confirmed that dense breast tissue is one do not account for some important 900 relating to mammography personnel of the factors that increases the chances clinical and mammographic scenarios, qualifications and image quality are not that a woman will develop breast cancer which could lead to confusing applicable to breast CT (§ 900.2(aa)). (Refs. 11 to 15). The CDC accordingly communication between interpreting FDA is also proposing to amend the lists dense breast tissue as one of the physicians and referring healthcare definition of ‘‘mammographic modality’’ risk factors for breast cancer (Ref. 16). providers, and may also lessen the to replace ‘‘xeromammography’’ as an Because dense breast tissue can obscure usefulness of the required medical example of a modality with ‘‘full field small cancers and is also a risk factor for outcomes audit if these cases are digital mammography,’’ as the former is breast cancer, some women with dense incorrectly classified. Classification of an obsolete technology (see § 900.2(z)). breasts may choose, after consulting the assessment of the mammogram is B. Repeated Failure of Accreditation with their healthcare provider, to part of the information that a undergo additional screening. mammography facility currently is FDA is proposing to add a new Additional screening of women with required to include in the subsection to the code of conduct and dense breasts can detect some mammography report (see general responsibilities requirements for additional cancers and reduce delays in § 900.12(c)(1)(iv)). Mammography accreditation bodies, which would treatment (Refs. 17 to 19). facilities classify their findings prohibit an accreditation body from On November 4, 2011, FDA convened regarding a mammogram using the accepting an application for an open public meeting of the following assessment categories: accreditation from a facility that has NMQAAC to consider possible changes Negative, benign, probably benign, failed to become accredited after three

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11674 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

consecutive attempts until 1 year after services make arrangements for access amend the equipment section to add a the most recent failed attempt (proposed by personnel to these records. new paragraph for equipment of other § 900.4(a)(6)(ii)). modalities (proposed § 900.12(b)(16)) D. Equipment and Quality Control Upon receipt of an accreditation that would require that systems with body’s decision that a facility has The proposed rule would amend parts image receptor modalities other than submitted the necessary information, of the equipment section to address screen-film demonstrate compliance FDA may issue a provisional certificate digital mammography and other with quality standards by successful to the facility so that it can perform changes in technology that have results of QA testing as specified in the mammography and obtain clinical occurred since publication of the section for quality control testing—other images for the purposes of ultimately current regulations (§ 900.12(b)). modalities (§ 900.12(e)(6)). meeting the requirements necessary for 1. Digital Accessories and Unit E. Mammography Reporting accreditation (and later certification). Conversion FDA’s experience with MQSA program FDA also is proposing to amend FDA is proposing to add a new section ‘‘Medical records and administration has shown that some provision that would require that mammography reports’’ (§ 900.12(c)). facilities repeatedly receive a facilities use only digital accessory The proposed rule would amend the provisional certificate—and continue to components that were either approved mammography reporting requirements perform mammography—but repeatedly or cleared by FDA specifically for as described below (see § 900.12(c)). Our resubmit and fail to achieve mammography or approved or cleared goal is to revise the mammography accreditation. This new subsection by FDA for a use that could include reporting regulations to increase the would prohibit an accreditation body mammography and that have the same clarity of communication among from accepting an application for equipment specifications as those mammography facilities, healthcare accreditation from a facility that has approved or cleared for mammography providers, and patients, facilitate the failed to become accredited after three (§ 900.12(b)(2)). All equipment must be retrieval of mammography images, and consecutive attempts until 1 year after designed for mammography. The help ensure that healthcare providers the most recent accreditation failure mechanism by which it is known that and patients are obtaining the necessary (proposed § 900.4(a)(6)(ii)). This would equipment is designed for information from the report of the help to ensure that facilities that have mammography is that it was approved results of a mammographic examination repeatedly failed to meet the required or cleared by FDA for that use. This to enable a woman and her healthcare quality standards will not continue to proposal clarifies that this is applicable provider to make informed healthcare offer mammography services while in to all equipment, including things such decisions. an unaccredited and provisionally as monitors. This change would ensure certified status. FDA believes that three 1. Contents and Terminology that only those components appropriate consecutive failures signify that a for mammography would be used Image quality contributes to accurate facility is not capable of performing clinically. interpretation of mammograms. The mammography that meets the required The proposed rule would also add a MQSA and implementing regulations quality standards. provision establishing that a are intended to ensure that quality C. Retention and Provision of Personnel mammography unit that is converted images are produced. However, FDA’s Records from one mammographic modality to experience has shown that some another is considered a new unit at the facilities copy or digitize clinical Mammography personnel in all facility under this part and, prior to images, and submit these copies, of categories (interpreting physicians, clinical use, must undergo a lesser quality than the original images, radiologic technologists, and medical mammography equipment evaluation to the interpreting physician for physicists) may work in more than one demonstrating compliance with interpretation. This can adversely affect mammography facility. Each facility is applicable requirements. The facility accuracy of interpretation. Therefore, to required to maintain records of the would also have to follow its ensure that the interpreting physician training and experience supporting the accreditation body’s procedures for interprets the actual images, which were qualification of each of its personnel applying for accreditation of that unit. performed in compliance with MQSA (see § 900.12(a)(4)). If a facility worker quality standards, FDA is proposing to loses his or her personal copy of these 2. X-Ray Film/Printer Film change this section on content and records, he or she may attempt to obtain FDA is proposing to rename ‘‘X-Ray terminology of medical records and copies from a facility where he or she film’’ to ‘‘Film’’ and insert the phrase mammography reports to require that works. Experience with MQSA program ‘‘For facilities using screen-film units’’ the mammograms submitted for administration has shown that facilities regarding the use of x-ray film interpretation be presented in the have refused reasonable requests by (§ 900.12(b)(11)). The revised section mammographic modality in which they personnel for copies of these records. also would contain an additional were originally produced, and not be When personnel cannot obtain copies of provision that would require that copied or digitized (§ 900.12(c)(1)). their records to document their facilities using hardcopy prints of 2. Facility Identification and Other qualifications, they may not be able to digital images for transfer, retention, or Information work at additional or new facilities, final interpretation purposes use a type which can lead to reduced public access of printer film designated by the film The existing section on content and to mammography services. FDA is manufacturer as appropriate for this terminology requires that a proposing to amend the retention of purpose and compatible with the printer mammography facility prepare a written personnel records section to require that being used to maintain image quality. report of each mammographic facilities provide copies of these records examination performed under its to personnel upon their reasonable 3. Quality Assurance Testing for certificate (§ 900.12(c)(1)). The proposed request (proposed § 900.12(a)(4)). It Equipment Other Than Screen-Film rule would add a requirement that the would further require that facilities that To ensure compliance with image report include the facility name and close or cease to provide mammography quality standards, FDA is proposing to location (at a minimum, the city, State,

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11675

and ZIP code of the facility) (proposed interpreting physician is aware of supported by the NMQAAC in 2006 § 900.12(c)(1)(ii)). This proposed clinical findings or symptoms, despite (Ref. 20). This category has two roles in addition would help to ensure that the benign assessment, these shall be current clinical practice. It is primarily healthcare providers know which explained).’’ The mammogram assigned used for a mammogram performed facility is providing the report of the this category is not truly ‘‘negative,’’ as following a biopsy to confirm the results of a mammographic examination it has one or more findings. However, deployment and position of a breast so they can follow up with the reporting these findings are benign, and no further tissue marker. During a biopsy using a facility as necessary in order to assist evaluation or follow up is needle to withdraw tissue from a their patients in making informed recommended. This change would suspicious breast lesion, a marker may healthcare decisions. promote greater consistency and be placed at the site, and The existing section on accuracy in the use of the ‘‘benign’’ final mammographic images are obtained to communication of mammography assessment category. assess and document the position of the results to the patients requires that the These proposed changes to the marker. If this mammogram facility provide each patient with a reporting requirements would add three demonstrates that the marker has not summary of the report in lay language new categories (listed below) of deployed or has migrated, placement of within 30 calendar days of the mammographic assessment to the another marker may be necessary before mammographic examination existing categories in the regulations concluding the procedure. Also, if the (§ 900.12(c)(2)). The proposed rule (proposed § 900.12(c)(1)(iv) through tissue biopsy result, when it becomes would revise this subsection to require (c)(1)(vi)). The addition of these available, shows cancer and further that the lay summary include the name categories would allow the surgery is necessary, the marker of the patient, and the name, address, mammography facility to more precisely identifies the site for further surgical and telephone number of the facility classify its findings. planning. The breast abnormality has performing the mammographic One proposed new category is already been found to be examination. This proposed addition ‘‘ ‘Known Biopsy Proven Malignancy.’ mammographically suspicious and would help to ensure that appropriate Reserved for known malignancies being warranting biopsy, and it will be mammography facility identification evaluated by mammography for definitively diagnosed by the tissue information is included in the lay definitive therapy’’ (see proposed biopsy result when available, so this summary sent to the patient. Experience § 900.12(c)(1)(iv)(F)). The addition of post-procedure mammogram does not has shown that inadequate facility this final assessment was recommended contribute to lesion characterization, identification information in in the IOM report of 2005 (Ref. 10), and other final assessments are not mammography reports and lay which was commissioned by Congress appropriate for this mammogram. The summaries can impede communication to address concerns about the quality of other use of this final assessment mammography image interpretation. among healthcare providers and category is for a mammogram performed This recommendation was also patients and hamper the timely to document the position of a supported by the NMQAAC in 2006 provision of medical care. localization needle. During needle (Ref. 22). This assessment would be localization, a needle is positioned as a 3. Mammographic Assessment used when breast imaging is performed temporary marker to direct subsequent Categories after a tissue diagnosis of cancer, but surgery for a nonpalpable lesion seen on Mammography facilities classify their before complete surgical removal of the earlier mammography. The post- findings regarding a mammogram using cancer. The category would alert procedure mammogram is performed as the categories listed in current providers who receive the report that a guide to identify the suspicious site categories for final assessment of the mammographic finding has already findings (§ 900.12(c)(1)(iv)), and they received additional evaluation, for the surgeon who will biopsy or report that classification in the written including tissue diagnosis, and is not a excise the lesion and remove the marker report of the results of each new finding that requires further needle. FDA determined that this mammography examination sent to the evaluation. Additionally, the category proposed category could be used as an healthcare provider. For each final would be relevant to the mammography alternative quality standard (see assessment category in the current medical outcomes audit, which is § 900.18) (Ref. 24). regulations, the words in quotation required under the MQSA regulations FDA proposes to add a third new marks are required to be included in the (see § 900.12(f)). For this required audit, category, ‘‘Incomplete: Need prior medical report, while the remaining each facility must have a system to track mammograms for comparison,’’ for language is intended to provide a mammogram that is found to be either those examinations where no final explanations of the categories to ‘‘suspicious’’ or ‘‘highly suggestive of assessment category can be assigned promote their consistent use but is not malignancy’’ and a process to correlate (proposed § 900.12(c)(1)(v)(B)). This required to be included in the medical the mammographic findings with biopsy assessment category would be reserved report. results. The ‘‘Known Biopsy Proven for examinations where comparison FDA is proposing to change the Malignancy’’ final assessment could be with prior mammograms should be explanatory language associated with used to exclude such cases from the performed before one of the other the ‘‘benign’’ assessment category to mammography medical outcomes audit, assessment categories is given. If this more accurately reflect and in order to avoid counting the same assessment category is used, a follow up communicate the intent of this category cancer case more than once in an audit. report with one of the other assessment (§ 900.12(c)(1)(iv)(B)). Currently the FDA determined that this proposed categories must be issued within 30 prescribed wording associated with this category could be used as an alternative calendar days of the initial report assessment is ‘‘ ‘Benign:’ Also a negative quality standard (see § 900.18) (Ref. 23). whether or not comparison views can be assessment.’’ FDA is proposing to The second proposed new category is obtained. The addition of this change the wording of this category to ‘‘Post-Procedure Mammograms for assessment category was also supported ‘‘ ‘Benign:’ Also a normal assessment, Marker Placement’’ (proposed by the NMQAAC in 2006 (Ref. 22). with benign findings present, but no § 900.12(c)(1)(iv)(G)). The addition of Comparison to previous examinations is evidence of malignancy (if the this final assessment category was also sometimes required to make a final

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11676 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

assessment. Assigning this ‘‘Incomplete: 5. Breast Density Notification delayed cancer diagnosis (Ref. 9). need prior mammograms’’ assessment as Clinical practice guidelines already Women with dense breasts who receive an assessment category would allow recommend that the interpreting the notification would have additional tracking of these examinations to ensure physician provide breast density information about their own anatomy either that prior examinations are information in the mammography report and be positioned to discuss this and obtained and compared in a timely to the referring healthcare provider (Ref. make more informed healthcare choices fashion, or, if they remain unavailable, 25). Moreover, as of May 2018, facilities with their healthcare providers. With that the current examination is given a in 34 States are also required by State knowledge of their breast density, some definitive final assessment in a timely law to provide breast density women may choose additional fashion. This proposed category is part information to patients (Ref. 21). screening using technology approved by of an assessment that FDA determined Proposed § 900.12(c)(1)(vi) would FDA, either with indications for use could be used as an alternative quality require that the patient’s breast density specifically for dense breasts, or known standard (see § 900.18) (Ref. 23). be included in the mammography report to be effective for evaluating dense that must be provided to the patient’s breasts, which could result in additional 4. Deadlines for Provision of Lay referring or named healthcare provider. cancers detected and reduce delays in Summary to Patient and Report to Proposed § 900.12(c)(1)(vi) would treatment. For example, a device for Provider establish four categories for reporting automated breast ultrasound has been FDA-approved for use in combination Current regulations require that if the breast tissue density in the mammography report: ‘‘The breasts are with a screening mammogram for final assessment in a mammography additional breast cancer screening in report is ‘‘Suspicious’’ or ‘‘Highly almost entirely fatty.’’, ‘‘There are scattered areas of fibroglandular women with dense breasts and a suggestive of malignancy,’’ the facility density.’’, ‘‘The breasts are negative mammogram. One study should make reasonable attempts to heterogeneously dense, which may showed that supplemental ultrasound ensure that the results are obscure small masses.’’, and ‘‘The screening in high-risk women with communicated to the patient and breasts are extremely dense, which dense breasts resulted in the detection healthcare provider as soon as possible lowers the sensitivity of of 1.1 to 7.2 additional cancers per 1,000 (§ 900.12(c)(2) and (c)(3)(ii)). FDA mammography.’’ These four categories women (Ref. 19). The detection of proposes adding a specific timeframe for are consistent with current clinical additional cancers has to be weighed delivery of medical reports to healthcare practice guidelines (Ref. 25). against any increase in false positive providers and the summary written in Based on discussion with the results (Ref. 28). lay language to patients whose NMQAAC in 2011 (Ref. 20), and 6. Mammography Self-Referrals mammograms have either of these two consistent with current clinical practice Current § 900.12(c)(2)(ii) requires that final assessment categories. (Ref. 26) as well as most State density ‘‘Each facility that accepts patients who notification laws (Ref. 27), for The proposed rule would amend do not have a healthcare provider shall notification to patients, FDA has communication of mammography maintain a system for referring such grouped these four categories of breast results to patients and healthcare patients to a healthcare provider when density into two broader groups: Low providers to require that, if the clinically indicated,’’ i.e., when density and high density. Proposed assessment of the mammography report necessitated by the presence of signs or § 900.12(c)(2)(iii) and (c)(2)(iv) would is ‘‘Suspicious’’ or ‘‘Highly suggestive of symptoms of disease. However, many require that the lay summary provided malignancy,’’ the facility must cases of breast cancer are identified due to patients identify whether the patient communicate the results to the referring to an abnormality on a mammogram, in has low or high density breasts and healthcare provider or a healthcare the absence of any clinical signs or include a prescribed paragraph on the provider named by the patient, within 7 symptoms. Proposed § 900.12(c)(2)(ii) significance of breast density. calendar days of the final interpretation FDA developed two patient density adds the term ‘‘mammographically’’ as of the mammographic examination but paragraphs, one intended for patients another indication for which facilities in no case later than 14 calendar days with low breast density and one for must maintain a system for referral to a from the date of the mammographic patients with high breast density with healthcare provider. This addition examination, and to the patient in the input from FDA’s Risk Communication would help to ensure that patients summary written in lay language, Advisory Committee. The paragraphs without healthcare providers and within 7 calendar days of the final contain an explanation of high breast receiving mammographic examinations interpretation of the mammographic tissue density, as well as specific topics from a mammography facility are examination but in no case later than 21 for women to discuss with their referred to healthcare providers when calendar days from the date of the healthcare providers. mammographically appropriate, i.e., mammographic examination The purpose of these proposed breast when appropriate based on the results (§ 900.12(c)(2) and (c)(3)). FDA would density notification requirements is to of the mammogram, as well as when require such action by the facility for provide women and their healthcare clinically appropriate. these two final assessment categories providers with additional information F. Recordkeeping because they both suggest a high regarding their mammography results possibility of malignancy. We believe and the potential limitations of those 1. Policies To Minimize Loss of Records that specifying a timeframe for results to enable women and their Current § 900.12(c)(4)(i) requires communicating these results, instead of healthcare providers to make informed facilities to maintain mammography the open-ended ‘‘as soon as possible,’’ healthcare decisions. As discussed films and reports in a permanent which is currently required, could lead previously, dense breast tissue increases medical record of the patient for a to earlier definitive tissue diagnosis of the risk of developing breast cancer period of not less than 5 years, or not malignancy and earlier start of (Refs. 11 to 13). Dense breast tissue can less than 10 years if no additional treatment, and avoid, for the patient, the also obscure mammographic signs of mammograms of the patient are anxiety of a protracted waiting period. breast cancer and thus result in a performed at the facility, or a longer

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11677

period if mandated by State or local law. releasing a copy upon the patient’s a diagnostic mammogram (consisting of FDA’s experience has shown that, with request. Delays in release of these copies individualized views for the evaluation the widespread use of electronic media can lead to delays in diagnosis or of a woman with breast symptoms, for the storage of soft copy images, treatment, so FDA is proposing to add physical signs of breast disease, or facilities face new technical challenges § 900.12(c)(4)(iii), which would require abnormal findings on a screening regarding maintaining the availability of that each facility that performs mammogram) (Ref. 31). Calculating and current and recent mammograms. Since mammograms, upon request by, or on tracking these three audit metrics would the loss of these images can have a behalf of, the patient, provide copies of allow facilities and interpreting significant impact on patient care, mammograms and copies of physicians to review their performance, facilities must address these challenges. mammogram reports to a medical evaluate their accuracy in detecting The proposed rule (proposed institution, a physician or healthcare breast cancer, and enact quality § 900.12(c)(4)(i)) would amend this provider of the patient, or to the patient improvement measures as necessary. As section to require each facility to directly, and that the release of the a result, FDA is proposing to revise implement policies and procedures to copies must take place within 15 § 900.12(f)(1) and add subparagraphs minimize the possibility of loss of these calendar days of the facility receiving § 900.12(f)(1)(i) through (f)(1)(iii) to records. In addition, since copying or such a request in order to facilitate clarify the minimum information that digitizing a mammographic image can prompt patient care. must be collected during the audit, degrade the quality of the image and including a determination of three of the 4. Facility Closure and Record Access potentially lead to incorrect diagnoses, most clinically significant metrics: the proposed rule would also require FDA is proposing to add Positive predictive value, cancer that, to preserve image quality, the § 900.12(c)(4)(v), which would provide detection rate, and recall rate. mammograms must be retained in that, before a facility closes or no longer H. Additional Mammography Review retrievable form in the mammographic provides mammography services, it and Patient and Referring Physician modality in which they were produced must make arrangements for the Notification and cannot be produced by copying or continued access by patients and digitizing hardcopy originals. healthcare providers to mammograms Existing § 900.12(j) addresses AMR and reports. This access may be and PPN. It sets forth the AMR 2. Transfer of Mammograms and provided by the permanent transfer of procedures, whereby FDA may require Mammography Reports mammograms and reports to the patient the facility to provide clinical images Current § 900.12(c)(4)(ii) requires or her healthcare provider or transfer of and other relevant information to the facilities, upon request by, or on behalf the mammograms and reports to a accreditation body or other entity of, the patient, to permanently or facility or other entity that will continue designated by FDA if FDA believes that temporarily transfer the original to provide access to patients and mammography quality at the facility has mammograms and copies of the healthcare providers within the time been compromised and may present a patient’s reports to a medical periods specified in § 900.12(c)(4)(i). serious risk to human health institution, a physician or healthcare The facility must notify its accreditation (§ 900.12(j)(1)). If FDA determines that provider of the patient, or to the patient body and certifying agency in writing of the quality of mammography performed directly. Since delays in the transfer of the arrangements it has made and must by a facility was so inconsistent with these records can lead to delays in make reasonable efforts to notify all the quality standard established in diagnosis or treatment, the FDA’s affected patients as to how to obtain § 900.12 as to present a significant risk proposed rule (proposed their records. to individual or public health, FDA may § 900.12(c)(4)(ii)) would amend this require such facility to issue a PPN to G. Mammography Medical Outcomes section to require facilities to release notify patients who received records within 15 calendar days of the Audit mammography at such facility and their facility receiving the transfer request in As part of recordkeeping referring physicians of the deficiencies order to facilitate prompt patient care. requirements, the existing MQSA and resulting potential harm, Also, copying or digitizing a regulations, § 900.12(f), require facilities appropriate remedial measures, and mammographic image can degrade the to perform an audit of medical outcomes other relevant information quality of the image and potentially lead of its mammography patients, but do not (§ 900.12(j)(2)). to incorrect diagnoses. Therefore, to specify the information to be collected Proposed revised § 900.12(j)(1) adds preserve image quality, the proposed or evaluated during this audit. Recently, the State certification agency as an rule would also require that the the clinical practice community entity that may initiate an AMR. transferred mammograms be in the recognized that specific audit metrics Proposed revised § 900.12(j)(2) would mammographic modality in which they are particularly relevant to continuous require that referring non-physician were produced, and cannot be produced quality improvement at mammography healthcare providers receive notification by copying or digitizing hardcopy facilities (Refs. 29 and 30). along with referring physicians (many originals. Additionally, for digital Based on this industry best practice, patients are referred for mammography mammograms or digital breast FDA is proposing to clarify the by non-physician healthcare providers), tomosynthesis, if the examination is minimum required components of the and expressly state that FDA and the being transferred for final interpretation medical outcomes audit, including the State certification agency can notify purposes, the facility must be able to calculation of three clinically significant patients and their providers provide the recipient with original metrics known as positive predictive individually or through the mass media digital images electronically. value, cancer detection rate, and recall when a facility is unable or unwilling to rate (see proposed § 900.12(f)(1)). The perform the required notification. This 3. Provision of Copies of Mammograms latter two metrics incorporate the proposed subsection also would make and Mammography Reports accepted clinical distinction between a clear that a PPN could be based on With the widespread use of digital screening mammogram (consisting of information discovered during the AMR mammography, facilities often retain the routine views for the earlier detection of or it could be based on other original mammogram even when cancer in an asymptomatic woman) and information. These proposals would

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11678 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

help to assure that quality 42 U.S.C. 263b(i) and not 41 U.S.C. result in an expenditure in any year that mammography services are provided 263b(i). meets or exceeds this amount. and that patients and providers are VI. Proposed Effective Date B. Summary of Benefits and Costs informed of significant risk to individual or public health resulting FDA proposes that any final rule that The proposed rule would modernize from mammography that fails to meet may issue based on this proposal mammography regulations by quality standards. become effective 18 months after the incorporating current science and date of publication of the final rule in mammography best practices to improve I. Additional Bases for Suspension or the delivery of mammography services. Revocation of a Certificate, and the Federal Register. Facilities need time to become familiar with new The proposed updates include Ineligibility To Own or Operate After requirements on recordkeeping, Revocation requirements and to add breast density reporting to their reporting systems. reporting, and communication of Revisions to § 900.14(a)(3) would results. This proposed rule also expressly state that FDA and State VII. Preliminary Economic Analysis of addresses procedural requirements in certification agencies can suspend or Impacts several areas related to quality control and management of mammography revoke the certificate of a facility that A. Introduction fails to comply with reasonable requests facilities. by FDA, the State certification agency, FDA has examined the impacts of the The benefits and costs associated with or the accreditation body for records, proposed rule under Executive Order this proposed rule are summarized in including clinical images for an AMR 12866, Executive Order 13563, table 1. The quantified benefits are under § 900.12(j). Experience with Executive Order 13771, the Regulatory derived from reduced mortality and MQSA program administration has Flexibility Act (5 U.S.C. 601–612), and breast cancer treatment costs resulting shown that some facilities are unable or the Unfunded Mandates Reform Act of from the breast density reporting unwilling to cooperate with 1995 (Pub. L. 104–4). Executive Orders requirements. In this analysis, we use submissions for such requested 12866 and 13563 direct us to assess all two methods of measuring the value of materials. The refusal to provide records costs and benefits of available regulatory reduced mortality: The value per can delay identification of serious risks alternatives and, when regulation is statistical life (VSL) approach and an to human health or delay notification of necessary, to select regulatory approach based on the value of lost significant risk to individual or public approaches that maximize net benefits quality-adjusted life years (QALY). health to affected patients and their (including potential economic, Under the VSL approach, the estimate of healthcare providers. environmental, public health and safety, annualized benefits over 10 years ranges In addition, proposed § 900.14(a)(7) and other advantages; distributive from $73.24 million to $466.75 million would state that FDA may suspend or impacts; and equity). Executive Order at a 7 percent discount rate. Using a 3 revoke the certificate of a facility that 13771 requires that the costs associated percent discount rate, the annualized fails to comply with reasonable requests with significant new regulations ‘‘shall, benefits range from $85.33 million to by current or former facility personnel to the extent permitted by law, be offset $534.03 million. Under the QALY for records documenting their by the elimination of existing costs approach, the estimate of annualized qualifications. Experience with MQSA associated with at least two prior benefits over 10 years ranges from program administration has also shown regulations.’’ We believe that this $16.27 million to $77.23 million at a 7 that facilities have refused reasonable proposed rule is a significant regulatory percent discount rate. Using a 3 percent requests to give copies of their records action as defined by Executive Order discount rate, the annualized benefits to the personnel named in the records. 12866. range from $16.27 million to $ 61.77. When personnel cannot obtain copies of Because there is uncertainty in the their records to document their The Regulatory Flexibility Act literature about the most appropriate qualifications under MQSA, they may requires us to analyze regulatory options method for analyzing reduced mortality be prevented from working at additional that would minimize any significant for the population affected by this or new facilities, which can lead to impact of a rule on small entities. proposed rule, we do not present a reduced public access to mammography Because many facilities that will be primary value and use estimates from services. affected by this rule are defined as small both methods to create the range of The MQSA (42 U.S.C. 263b(i)) states businesses, we find that the proposed values in Table 1. The high estimate in that upon the finding of certain acts, rule will have a significant economic Table 1 is based on the VSL approach, such as misrepresentation in obtaining a impact on a substantial number of small which yields the higher bound estimate certificate, failure to comply with entities. of the two methods. The low estimate is quality standard requirements, failure to The Unfunded Mandates Reform Act based on the QALY approach, which provide certain information to FDA in of 1995 (section 202(a)) requires us to yields the lower bound estimate of the response to reasonable requests, failure prepare a written statement, which two methods. Other benefits that we are to permit inspection, violation of any includes an assessment of anticipated not able to quantify include provision of the MQSA or regulation costs and benefits, before proposing improvements in the accuracy of promulgated under the MQSA, and ‘‘any rule that includes any Federal mammography by improving quality failure to comply with a sanction, a mandate that may result in the control and records management, and facility’s certificate may be revoked. If a expenditure by State, local, and tribal effects on morbidity. facility’s certificate is revoked, persons governments, in the aggregate, or by the The costs of the proposed rule include who owned or operated the facility at private sector, of $100,000,000 or more costs to mammography facilities to the time of revocation are ineligible to (adjusted annually for inflation) in any comply with the proposed requirements own or operate a mammography facility one year.’’ The current threshold after and costs associated with supplemental for 2 years. adjustment for inflation is $150 million, testing and biopsies resulting from the FDA is also revising § 900.11(c) to using the most current (2017) Implicit breast density requirements. The correct a citation error to the MQSA and Price Deflator for the Gross Domestic estimate of annualized costs over 10 make clear that § 900.14(c) implements Product. This proposed rule would years ranges from $34.96 million to

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11679

$60.50 million at a 7 percent discount million to $59.40 million with a primary percent discount rate and $391.74 rate with a primary value of $47.03 value of $45.92 million. The primary million at a 3 percent discount rate. million. Using a 3 percent discount rate, estimate of the present value of costs the annualized costs range from $33.86 over 10 years is $330.29 million at a 7 TABLE 1—SUMMARY OF BENEFITS AND COSTS IN MILLIONS 2017 DOLLARS OVER A 10-YEAR TIME HORIZON

Units Primary Category estimate Low estimate High estimate Discount rate Period Notes Year dollars (%) covered

Benefits: Annualized ...... $16.27 $466.75 2017 7% 10 years Monetized $/year ...... 16.27 534.03 2017 3 10 years Annualized Quantified ...... 7 3

Qualitative ...... Improvements in the accuracy of mammography and better management of mammography fa- cilities.

Costs: Annualized Monetized $/year ... 47.03 34.96 60.50 2017 7 10 years 45.92 33.86 59.40 2017 3 10 years Annualized Quantified ...... 7 3 Qualitative. Transfers: Federal ...... 7 Annualized Monetized $/year ...... 3

From/To ...... From: To:

Other ...... 7 Annualized Monetized $/year ...... 3

From/To ...... From: To:

Effects: State, Local or Tribal Government: Small Business: Annual cost per affected small entity estimated as 357-623, which would represent a maximum of 2.7 percent of annual receipts Wages: Growth:

In line with Executive Order 13771, in savings over an infinite time horizon. would be considered a regulatory action table 2 we estimate present and Based on these costs this proposed rule under E.O. 13771. annualized values of costs and cost

TABLE 2—EO 13771 SUMMARY TABLES IN MILLIONS 2016 DOLLARS OVER AN INFINITE TIME HORIZON

Primary Lower bound Upper bound Primary Lower bound Upper bound (7%) (7%) (7%) (3%) (3%) (3%)

Present Value of Costs ...... $615.44 $446.14 $804.56 $1,378.67 $983.65 $1,819.96 Present Value of Cost Savings ...... 0 0 0 0 0 0 Present Value of Net Costs ...... 615.44 446.14 804.56 1,378.67 983.65 1,819.96 Annualized Costs...... 43.08 31.23 56.32 41.36 29.51 54.60 Annualized Cost Savings ...... 0 0 0 0 0 0 Annualized Net Costs...... 43.08 31.23 56.32 41.36 29.51 54.60

C. Summary of Regulatory Flexibility One-time costs are 26.7 percent of The full analysis of economic impacts Analysis receipts and annual costs are 4.1 percent is available in the docket for this We estimate that there are 4,585 non- of receipts for the smallest diagnostic proposed rule (Ref. 32) and at https:// hospital facilities and 4,106 hospitals imaging centers. Based on this, we www.fda.gov/AboutFDA/ReportsMan that perform mammography. A conclude that the proposed rule, if ualsForms/Reports/EconomicAnalyses/ minimum of 3,865 of the mammography finalized, would have a significant default.htm. We solicit comment about facilities in operation for the entire year, impact on a substantial number of small the analysis of economic impacts. or 95 percent of the total, would be entities. The proposed regulation would VIII. Analysis of Environmental Impact small. At least 382 of all hospitals with have smaller effects on hospitals less than $10 million in annual receipts, because they provide more diversified The Agency has determined under 21 or 9 percent of the total, are small. The services and tend to be larger. We have CFR 25.30(h) that this action is of a type estimated one-time cost is $4,100 to developed a comprehensive Economic that does not individually or $6,474 per facility. The estimated Analysis of Impacts that assesses the cumulatively have a significant effect on annual cost is $357 to $623 per facility. impacts of the proposed rule. the human environment. Therefore,

VerDate Sep<11>2014 19:13 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11680 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

neither an environmental assessment are subject to review functions, help ensure that healthcare providers nor an environmental impact statement including whether the information will and patients obtain the necessary is required. have practical utility; (2) the accuracy of information from the mammography FDA’s estimate of the burden of the facility to enable a woman and her IX. Paperwork Reduction Act of 1995 proposed collection of information, healthcare provider to make informed This proposed rule refers to including the validity of the healthcare decisions. FDA also is previously approved collections of methodology and assumptions used; (3) proposing additional categories be information that are subject to review by ways to enhance the quality, utility, and added to the list of assessments that the Office of Management and Budget clarity of the information to be facilities are required to use in the (OMB) under the Paperwork Reduction collected; and (4) ways to minimize the mammography report. In addition, FDA Act of 1995 (PRA) (44 U.S.C. 3501– burden of the collection of information is proposing to amend its requirements 3520). The collections of information in on respondents, including through the related to the transfer and provision of part 900 have been approved under use of automated collection techniques, mammography records, the transfer and OMB control number 0910–0309. The when appropriate, and other forms of provision of personnel records upon proposed amendments to part 900 in information technology. request or facility closure, and FDA this document necessitate revisions to Title: Mammography Facilities, notification and mammographic records OMB control number 0910–0309. A Standards, and Lay Summaries for access upon facility closure. description of the proposed Patients. Description of Respondents: amendments that necessitate revisions Description: FDA is proposing to Respondents to this information to the annual third-party disclosure amend its mammography reporting collection are facilities that provide burden is given in the Description requirements to require that the mammographic examinations and State section below. Included in the estimate mammography report provided to the certification. is the time for reviewing instructions, healthcare provider and the lay searching existing data sources, summary report provided to the patient Agencies: As of May 1, 2018, FDA gathering and maintaining the data include basic mammography facility internal data on facilities showed that needed, and completing and reviewing identification information and there were 8,691 facilities certified to each collection of information. information concerning patient breast perform mammography. In addition to FDA invites comments on these density. This action is intended to mammography-performing facilities, the topics: (1) Whether the proposed facilitate communication between regulation would also affect four State collection of information is necessary mammography facilities, healthcare certification agencies (Ref. 33). for the proper performance of FDA’s providers, and patients; facilitate the FDA estimates the burden of this information collection provisions that retrieval of mammography images; and collection of information as follows:

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of Total Number of disclosures Average burden 2 Activity/21 CFR section respondents per annual per disclosure Total hours respondent disclosures

Provision of personnel records—900.12(a)(4) ...... 608 1 608 0.08 (5 minutes) ..... 49 Transfer of personnel records by closing facilities— 87 1 87 5...... 435 900.12(a)(4). New assessment categories and breast density re- 8,691 1 8,691 23...... 199,893 porting in mammography report (one-time bur- den)—900.12(c)(1)(iv)–(c)(1)(vi). Breast density reporting in lay summary (one-time 8,691 1 8,691 11...... 95,601 burden)—900.12(c)(2). Transfer/provision of copies of mammograms and 8,691 1,508 13,109,566 0.08 (5 minutes) ..... 1,048,765 records upon patient’s request—900.12(c)(4)(ii) and (c)(4)(iii). Facility closure; notification and records access— 87 1 87 32...... 2,784 900.12(c)(4)(v). Patient notification of significant risk (by State certifi- 5 1 5 100...... 500 cation agency)—900.12(j)(2).

Total ...... 1,348,027 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Columns may not sum due to rounding.

Personnel records—§ 900.12(a)(4): inspection and until FDA has Also under proposed § 900.12(a)(4), Under § 900.12(a)(4), facilities are determined that the facility is in facilities would have to provide copies required to maintain records of training compliance with the MQSA personnel of personnel records to current or and experience regarding personnel requirements. FDA is not proposing any former interpreting personnel who work or have worked at the facility changes to these requirements. The (physician, radiological technologist as interpreting physicians, radiologic information collection (recordkeeping) and medical physicist) upon their technologists, or medical physicists. burden for this provision is currently reasonable request. We estimate that Facilities must maintain records of approved under OMB control number there are, on average, seven interpreting personnel no longer employed by the 0910–0309. personnel per facility (approximately facility at least until the next annual 60,837 total). We estimate that 1 percent

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11681

of these personnel (608 personnel 0910–0309, because it was considered Under proposed § 900.12(c)(4)(i), annually) would request the records and usual and customary practice and was facilities that perform mammograms that it would take approximately 5 part of the standard of care prior to the must maintain mammographic records. minutes to provide the copies for each implementation of the regulations (see 5 The proposed rule would require that request. CFR 1320.3(b)(2)). Provision of the facilities implement policies and Additionally, under proposed mammography report to healthcare procedures to minimize the possibility § 900.12(a)(4), before a facility closes or providers continues to be part of the of record loss and would require that ceases to provide mammography standard of care and remains the usual records be maintained in the modality services, it would have to make and customary business practice. in which they were produced. We arrangements for personnel to access Therefore, these changes would not estimate these proposed additions their MQSA personnel records. This result in additional burden. would not result in a change to the access may be provided by the Under § 900.12(c)(2), Communication currently approved information permanent transfer of these records to of mammography results to the patients, collection burden. the personnel or the transfer of the within 30 days of the mammographic Under § 900.12(c)(4)(ii), facilities records to a facility or other entity that examination, each facility shall provide shall, upon request by or on behalf of would provide access to these records. each patient a summary of the the patient, transfer or release the We estimate that annually 1 percent of mammography report written in lay mammograms and copies of the the total facilities would close or cease terms. Under the proposed rule, if the patient’s reports to a medical to provide mammography services and final assessment is ‘‘Suspicious’’ or institution, a physician or healthcare that it would take each of the facilities ‘‘Highly suggestive of malignancy,’’ the provider of the patient, or to the patient approximately 5 hours to transfer the facility would have to provide the directly. Under proposed records. patient a summary of the mammography § 900.12(c)(4)(ii) and (c)(4)(iii), facilities Medical records and mammography report within a specified timeframe would need to transfer original reports—§ 900.12(c)(1) through (c)(4): (proposed § 900.12(c)(2)); the current mammograms (and copies of associated Section 900.12(c)(1), Contents and regulation states that facilities must reports) or provide copies of terminology, sets forth the requirement make reasonable attempts to provide the mammograms (and copies of associated for facilities to prepare a written report report in such situations ‘‘as soon as reports) within a specified period of of the results of each mammographic possible.’’ Under the proposed rule, this time. Copies of mammograms would examination performed under its summary would need to include the need to be in the same modality in certificate. Section 900.12(c)(1) requires name of the patient and name, address, which they were produced. Moreover, that the report include patient and telephone number of the facility. for digital mammograms or digital breast identifying information, date of We estimate that the proposed tomosynthesis, the facility would have examination, facility name and location, requirements for the lay summary to to be able to provide the recipient with the final assessment of findings (or include this information would not original digital images electronically if classification as to why no final result in a change to the currently the examination is being transferred for assessment can be made), name of the approved information collection burden final interpretation. While the burden of interpreting physician, and for § 900.12(c)(2). maintaining records under § 900.12(c)(4) recommendations to the healthcare Proposed § 900.12(c)(2) also would is included in the currently approved provider. require facilities to provide an burden estimate, the currently approved This proposed rule would include assessment of breast density in the lay burden estimate does not include the two additional final assessment summary. We estimate a one-time third-party disclosure burden of categories and an additional burden for facilities to update their transferring the records. We estimate classification in the mammography existing lay summary reports with the that approximately one third of patients report and would also require an breast density assessments. Based on the would request transfer or release of the assessment of breast density in the ERG report, we believe this would take records (this equals an average of report (proposed § 900.12(c)(1)(iv) 11 hours per facility (Ref. 34). approximately 1,508 requests per through (c)(1)(vi)). We estimate a one- Also, under § 900.12(c)(2)(ii), each facility) and it would take time burden for facilities to update their facility that accepts patients who do not approximately 5 minutes per request. existing mammography reports with have a healthcare provider shall Under proposed § 900.12(c)(4)(v), these new categories. Based on the maintain a system for referring such before a facility closes or ceases to Eastern Research Group (ERG), Inc.’s patients to a healthcare provider when provide mammography services, it report, we believe this would take 23 clinically indicated. The proposed rule would have to make arrangements for hours per facility (Ref. 34). would also require that the system access by patients and healthcare Under the proposed rule, if the final provide referrals when providers to their mammographic assessment is ‘‘Suspicious’’ or ‘‘Highly ‘‘mammographically’’ indicated. We records. Additionally, the facility would suggestive of malignancy,’’ the facility estimate this proposed addition would have to notify its accreditation body and would have to provide the report to the not result in a change to the currently certification agency in writing of the healthcare provider, or if the referring approved information collection arrangements it has made and must healthcare provider is unavailable, to a burden. make reasonable efforts to notify all responsible designee (proposed The proposed requirements in affected patients. We estimate that 1 § 900.12(c)(3)(ii)) within a specified § 900.12(c)(2)(iii) and (c)(2)(iv) to percent of facilities would close on an timeframe; the current regulation states provide an explanation of the breast annual basis and that it would take each that facilities must make reasonable density assessment identified in facility approximately 32 hours to attempts to provide the report in such § 900.12(c)(1)(vi) are not considered to provide notification and access to the situations ‘‘as soon as possible.’’ The be ‘‘collections of information’’ because records. provision of the report to the healthcare the language is originally supplied by Quality assurance-mammography provider was not included in the the Federal government for the purpose medical outcomes audit—§ 900.12(f): currently approved information of disclosure to members of the public Section 900.12(f)(1) requires each collection burden, OMB control number (5 CFR 1320.3(c)(2)). facility to establish a system to collect

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11682 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

and review outcome data for all 395–7285, or emailed to oira_ State agencies serving as accreditation mammographic examinations [email protected]. All bodies. performed, including follow up on the comments should be identified with the On November 4, 2011, FDA convened disposition of all positive mammograms title, ‘‘Mammography Facilities, a public meeting of the NMQAAC where and correlation of pathology results Standards, and Lay Summaries for possible amendments to the MQSA with the interpreting physician’s Patients (OMB control number 0910– regulations, including breast density mammography report. The proposed 0309)’’. reporting, were discussed (Ref. 18). This rule would clarify that positive In compliance with the PRA (44 meeting was open to the public and predictive value, cancer detection rate, U.S.C. 3407(d)), the Agency has time was allotted for public statements and recall rate would have to be submitted the information collection on issues of concern in the collected during this audit. We estimate provisions of this proposed rule mammography field. FDA has also met that the proposed clarifications would (revisions of collections approved under and held teleconferences several times a not result in a change to the currently OMB control number 0910–0309) to year with its approved accreditation approved information collection OMB for review. These requirements bodies and State certification agencies burden. will not be effective until FDA obtains to discuss issues of mutual concern. Additional mammography review and OMB approval. FDA will publish a The Agency also has long enjoyed a patient and referring physician notice concerning OMB approval of good relationship with the Conference notification—§ 900.12(j): Under these requirements in the Federal of Radiation Control Program Directors, § 900.12(j)(1), if FDA believes that Register. Inc. (CRCPD), which is the professional mammographic quality at a facility has X. Federalism organization of the State agencies been compromised and may present a concerned with radiation protection. serious risk to human health, the facility The MQSA established minimum The CRCPD has established a standing must provide clinical images and other national quality standards for Mammography Committee, which meets relevant information for review by the mammography. The MQSA replaced a with FDA mammography staff at least accreditation body or other entity patchwork of Federal, State, and private once a year. designated by FDA. Under the proposed standards with uniform Federal For the reasons discussed previously, rule, the State certification agency may standards designed to ensure that all FDA believes that this proposed rule is request and then review such women nationwide receive adequate consistent with the federalism information. We estimate these quality mammography services. FDA principles expressed in Executive Order proposed revisions would not result in has worked very closely with State 13132. a change to the currently approved officials in developing the national information collection burden. standards for the MQSA program and XI. References Under § 900.12(j)(2), when FDA has has sought and obtained input from The following references are on determined that the quality of States at every step of the process. display in the Dockets Management mammography performed by the facility FDA issued final rules implementing Staff (see ADDRESSES) and are available poses a significant risk to human health, the MQSA on October 28, 1997 for viewing by interested persons a facility may be required to notify all (‘‘Quality Mammography Standards,’’ 62 between 9 a.m. and 4 p.m., Monday patients who received mammograms at FR 55852) and February 6, 2002 (‘‘State through Friday; they are also available the facility or those patients who are Certification of Mammography electronically at https:// determined to be at risk due to the Facilities,’’ 67 FR 5446). As required by www.regulations.gov. FDA has verified quality of their mammography, and Executive Order 13132 (August 4, 1999), the website addresses, as of the date this their referring physicians of the FDA prepared a federalism assessment document publishes in the Federal deficiencies and resulting potential in this latter final rule and determined Register, but websites are subject to harm, appropriate remedial measures, that the rule was consistent with the change over time. and other relevant information. Under federalism principles expressed in 1. Centers for Disease Control and the proposed rule, facilities would need Executive Order 13132. Prevention, ‘‘Breast Cancer Statistics.’’ to notify referring non-physician The proposed amendments to the Available at www.cdc.gov/cancer/breast/ healthcare providers (along with MQSA regulations, among other things, statistics. referring physicians). We estimate this are intended to amend the requirements 2. National Institutes of Health, National proposed revision would not result in a for reporting to healthcare providers and Cancer Institute, ‘‘Surveillance, change to the currently approved patients to assure that patients receive Epidemiology, and End Results information collection burden. Also all necessary information after their Program.’’ Available at https://seer.can under the proposed rule, State mammograms, including an assessment cer.gov/statfacts/html/breast.html. certification agencies (along with FDA) of breast density, while not unduly 3. Centers for Disease Control and Prevention, ‘‘Cancer Among Women.’’ would have the authority to notify burdening the mammography facility. Available at http://www.cdc.gov/cancer/ patients and their providers if a facility Although certain proposed provisions dcpc/data/women.htm. is unable or unwilling to do so. We impact Federal-State relations, FDA 4. Michaelson, J.S., M. Silverstein, J. Wyatt, estimate that the burden to State does not believe that they impose any et al., ‘‘Predicting the Survival of certification agencies would be similar additional, significant burden on the Patients with Breast Carcinoma Using to the approved burden estimate for States. The division of responsibilities Tumor Size,’’ Cancer, 2002; 95(4): facilities; approximately five between FDA, the States, and State 713-723. notifications per year will take 100 agencies would not change if the 5. American Cancer Society, ‘‘Can Breast hours per notification. proposed regulations were finalized, as Cancer Be Found Early?’’ Available at To ensure that comments on these proposals would continue to http://www.cancer.org/cancer/ breastcancer/detailedguide/breast- information collection are received, provide for necessary uniformity of cancer-detection. OMB recommends that written minimum national standards and, at the 6. Government Accountability Office, ‘‘GAO– comments be faxed to the Office of same time, provide maximum flexibility 06–724 Mammography: Current Information and Regulatory Affairs, to States administering the States as Nationwide Capacity Is Adequate, but OMB, Attn: FDA Desk Officer, Fax: 202– Certifier program within their State, and Access Problems May Exist in Certain

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11683

Locations (July 2006).’’ Available at 19. Berg, W.A., J.D. Blume, J.B. Cormack, et Interpretation in Breast Cancer http://www.gao.gov/new.items/ al., ‘‘Combined Screening With Screening, Washington, DC, May 12–13, d06724.pdf. Ultrasound and Mammography 2015. 7. Improving the Quality of Mammography: Compared to Mammography Alone in 30. Sickles, E.A. and C.J. D’Orsi, ‘‘ACR BI– How Current Practice Fails. Hearing Women at Elevated Risk of Breast Cancer RADS Follow-Up and Outcome before the Subcommittee on Aging of the of the First-Year Screen in ACRIN 6666,’’ Monitoring.’’ In: ACR BI–RADS Atlas: Committee on Labor and Human Journal of the American Medical Breast Imaging Reporting and Data Resources, United States Senate, 102d Association, 2008; 299(18); 2151–2163. System, 5th ed., Reston, VA: American Congress, 1992. Available at https://www.ncbi. College of Radiology, 2013. 8. The Failure and Success of Current nlm.nih.gov/pmc/articles/PMC2718688/ 31. Sickles, E.A., C.J. D’Orsi, L.W. Bassett, et Mammography Practice: The Need for pdf/nihms73151.pdf. al., ‘‘ACR BI–RADS Mammography.’’ In: Strong Federal Quality Standards. 20. U.S. Food and Drug Administration, ACR BI–RADS Atlas: Breast Imaging Hearing before the Subcommittee on Public Meeting Materials, National Reporting and Data System, 5th ed., Aging of the Committee on Labor and Mammography Quality Assurance Reston, VA: American College of Human Resources, United States Senate, Advisory Committee (NMQAAC) Radiology, pp. 7–8, 2013. 102d Congress, 1992. meeting, 24-Hour Summary, November 32. Analysis of Economic Impacts. Available 9. American College of Radiology/Society of 4, 2011. Available at https://wayback. at http://www.fda.gov/AboutFDA/ Breast Imaging, ‘‘Breast Density: Breast archive-it.org/7993/20170404143639/ ReportsManualsForms/Reports/ Cancer Screening.’’ Available at https:// https://www.fda.gov/downloads/ EconomicAnalyses/default.htm. www.acr.org/-/media/ACR/Files/Breast- AdvisoryCommittees/Committees 33. U.S. Food and Drug Administration, Imaging-Resources/Breast-Density-bro_ MeetingMaterials/Radiation-Emitting _ MQSA National Statistics, 2018. ACR SBI.pdf. Products/NationalMammographyQuality Available at http://www.fda.gov/ 10. Institute of Medicine, ‘‘Improving Breast AssuranceAdvisoryCommittee/UCM27 Radiation-EmittingProducts/ Imaging Quality Standards.’’ May 23, 9484.pdf. MammographyQualityStandardsAct 2005. Available at https://www.nap.edu/ 21. Dense Breast Info website. Available at andProgram/FacilityScorecard/ read/11308/chapter/1. http://densebreast-info.org/ ucm113858.htm. 11. McCormack, V.A. and I. dos Santos Silva, legislation.aspx. 34. Eastern Research Group, Inc., ‘‘Baseline ‘‘Breast Density and Parenchymal 22. Transcript of the National Mammography Patterns as Markers of Breast Cancer Quality Measures of Screening Quality Assurance Advisory Committee Mammography and the Impacts of Risk: A Meta-Analysis,’’ Cancer (NMQAAC) meeting, September 28–29, Epidemiology, Biomarkers, and Proposed Revisions to Regulations 2006. Available at http://www.access Implementing the Mammography Prevention, 2006; 15: 1159–1169. data.fda.gov/scripts/cdrh/cfdocs/ 12. Boyd, N.F., H. Guo, L.J. Martin, et al., Quality Standards Act.’’ Final Report, cfAdvisory/details.cfm?mtg=636. ‘‘Mammographic Density and the Risk July 19, 2012. (ERG, 2012a). 23. MQSA Alternative Standard #11, and Detection of Breast Cancer,’’ New approved on August 29, 2003. Available England Journal of Medicine, 2007; 356: List of Subjects in 21 CFR Part 900 at http://www.fda.gov/Radiation- 227–236. EmittingProducts/MammographyQuality Electronic products, Health facilities, 13. Vachon, C.M., C.H. van Gils, T.A. Sellers, StandardsActandProgram/Regulations/ et al., ‘‘Mammographic Density, Breast Medical devices, Radiation protection, Cancer Risk and Risk Prediction,’’ Breast ucm259289.htm. Reporting and recordkeeping Cancer Research, 2007; 9: 217. 24. MQSA Alternative Standard #12, requirements, X-rays. approved on September 17, 2003. 14. Gastounioti, A., E.F. Conant, and D. Therefore, under the Federal Food, Kontos, ‘‘Beyond Breast Density: A Available at http://www.fda.gov/ Radiation-EmittingProducts/ Drug, and Cosmetic Act and under Review on the Advancing Role of authority delegated to the Commissioner Parenchymal Texture Analysis in Breast MammographyQualityStandardsActand Cancer Risk Assessment,’’ Breast Cancer Program/Regulations/ucm259290.htm. of Food and Drugs, 21 CFR part 900 is Research, 2016; 18: 19. Available at 25. Sickles, E.A., C.J. D’Orsi, L.W. Bassett, et amended as follows: https://doi.org/10.1186/s13058-016- al., ‘‘ACR BI–RADS Mammography.’’ In: 0755-8. ACR BI–RADS Atlas: Breast Imaging PART 900—MAMMOGRAPHY 15. Guterbock, T., W.F. Cohn, D.L. Rexrode, Reporting and Data System, 5th ed., ■ et al. ‘‘What Do Women Know About Reston, VA: American College of 1. The authority citation for part 900 Breast Density? Results From a Radiology, pp. 123–126, 2013. continues to read as follows: Population Survey of Virginia Women,’’ 26. American Cancer Society, ‘‘Breast Density and Your Mammogram Report.’’ Authority: 21 U.S.C. 360i, 360nn, 374(e); Journal of the American College of 42 U.S.C. 263b. Radiology. 2017; 14: 34–44. Available at Available at https://www.cancer.org/ https://doi.org/10.1016/j.jacr.2016.0 cancer/breast-cancer/screening-tests- ■ 2. Amend § 900.2 by revising 7.003. and-early-detection/mammograms/ paragraphs (z), (aa)(1) and (2), and by 16. Centers for Disease Control and breast-density-and-your-mammogram- adding new paragraph (aa)(3) to read as Prevention, ‘‘What Are the Risk Factors report.html. follows: for Breast Cancer?’’ Available at http:// 27. Ho, J.M., N. Jafferjee, G.M. Covarrubias, www.cdc.gov/cancer/breast/basic_info/ et al., ‘‘Dense Breasts: A Review of § 900.2 Definitions. _ Reporting Legislation and Available risk factors.htm. * * * * * 17. Kolb, T.M., J. Lichy, and J.H. Newhouse, Supplemental Screening Options,’’ ‘‘Comparison of the Performance of American Journal of Roentgenology, (z) Mammographic modality means a Screening Mammography, Physical 2014; 203: 449–456. technology, within the scope of 42 Examination, and Breast US and 28. Melnikow, J., J.J. Fenton, E.P. Whitlock, U.S.C. 263b, for radiography of the Evaluation of Factors That Influence et al., ‘‘Supplemental Screening for breast. Examples are screen-film Them: An Analysis of 27,825 Patient Breast Cancer in Women With Dense mammography and full field digital Evaluations,’’ Radiology, 2002; 225: 165– Breasts: A Systematic Review for the mammography. 175. U.S. Preventive Services Task Force,’’ (aa) * * * 18. Leconte, I., C. Feger, C. Galant, et al., Annals of Internal Medicine 2016; (1) Radiography of the breast 164(4): 268–278. Available at http:// ‘‘Mammography and Subsequent Whole- performed during invasive interventions Breast Sonography of Nonpalpable annals.org/article.aspx?articleid= Breast Cancers: The Importance of 2480756. for localization or biopsy procedures; Radiologic Breast Density,’’ American 29. D’Orsi, C.J., ‘‘Audit.’’ Lecture presented at (2) Radiography of the breast Journal of Roentgenology, 2003; 180: Institute of Medicine workshop on performed with an investigational 1675–1679. Assessing and Improving Imaging mammography device as part of a

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11684 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

scientific study conducted in reasonable request. Before a facility (ii) Date of examination, facility name, accordance with FDA’s investigational closes or ceases to provide and location. At a minimum, the device exemption regulations in part mammography services, it must make location shall include the city, State, 812 of this chapter; or arrangements for access by personnel to ZIP code, and telephone number of the (3) Computed tomography of the their MQSA personnel records. This facility; breast. access may be provided by the (iii) The name of the interpreting * * * * * permanent transfer of these records to physician who interpreted the ■ 3. Amend § 900.4 by redesignating the personnel or the transfer of the mammogram; paragraph (a)(6) as (a)(6)(i) and by records to a facility or other entity that (iv) Overall final assessment of adding new paragraph (a)(6)(ii). will provide access to these records. findings, classified in one of the The addition reads as follows: (b) * * * following categories: (2) * * * (A) ‘‘Negative:’’ Nothing to comment § 900.4 Standards for accreditation bodies. (i) All digital accessory components upon (if the interpreting physician is (a) * * * shall be approved or cleared by FDA, aware of clinical findings or symptoms, (6)(i) * * * (A) Specifically for mammography or, despite the negative assessment, these (ii) If a facility has failed to become (B) For a use that could include shall be explained); accredited after three consecutive mammography and have the same (B) ‘‘Benign.’’ Also, a normal result, attempts, an accreditation body shall equipment specifications as those with benign findings present, but no not accept an application for approved or cleared by FDA specifically evidence of malignancy (if the accreditation from the facility for a for mammography. interpreting physician is aware of period of 1 year from the date of the (ii) A mammography unit that is clinical findings or symptoms, despite most recent accreditation failure. converted from one mammographic the benign assessment, these shall be * * * * * modality to another is considered a new explained); ■ 4. In § 900.11 revise paragraph (c)(4) unit at the facility under this part and (C) ‘‘Probably Benign:’’ Finding(s) has to read as follows: must, prior to clinical use, undergo a a high probability of being benign; mammography equipment evaluation § 900.11 Requirements for certification. (D) ‘‘Suspicious:’’ Finding(s) without demonstrating compliance with all the characteristic morphology of * * * * * applicable requirements. The facility breast cancer but indicating a definite (c) * * * must also follow its accreditation body’s probability of being malignant; (4) If a facility’s certificate was procedures for applying for (E) ‘‘Highly suggestive of revoked on the basis of an act described accreditation of that unit. malignancy:’’ Finding(s) has a high in 42 U.S.C. 263b(i)(1), as implemented * * * * * probability of being malignant; by § 900.14(a), no person who owned or (11) Film. For facilities using screen- (F) ‘‘Known Biopsy Proven operated that facility at the time the act film units, the facility shall use x-ray Malignancy.’’ Reserved for known occurred may own or operate a film for mammography that has been malignancies being mammographically mammography facility within 2 years of designated by the film manufacturer as evaluated for definitive therapy; and the date of revocation. appropriate for mammography. For (G) ‘‘Post-Procedure Mammograms for ■ 5. Amend § 900.12 by: ■ facilities using hardcopy prints of Marker Placement.’’ Reserved for a post- a. Revising paragraph (a)(4); digital images for transfer, retention, or ■ b. Adding paragraphs (b)(2)(i) and (ii); procedure mammogram used to confirm final interpretation purposes, the facility ■ c. Revising paragraph (b)(11); the deployment and position of a breast shall use a type of film designated by ■ d. Adding paragraph (b)(16); and tissue marker. ■ e. Revising paragraphs (c)(1) and (2), the film manufacturer as appropriate for (v) In cases where no final assessment (c)(3)(ii), (c)(4), (f)(1), and (j). these purposes and compatible with the category can be assigned due to The additions and revisions read as printer being used. incomplete work-up, one of the follows: * * * * * following classifications shall be (16) Equipment—other modalities. assigned as an assessment and reasons § 900.12 Quality standards. Systems with image receptor modalities why no assessment can be made shall be (a) * * * other than screen-film shall demonstrate stated by the interpreting physician. (4) Retention of personnel records. compliance with quality standards by (A) ‘‘Incomplete: Need additional Facilities shall maintain records of successful results of quality assurance imaging evaluation.’’ Reserved for training and experience relevant to their testing as specified under paragraph examinations where additional imaging qualification under MQSA for personnel (e)(6) of this section. needs to be performed before an who work or have worked at the facility (c) Medical records and assessment category identified in as interpreting physicians, radiologic mammography reports—(1) Contents paragraph (c)(1)(iv)(A) through (G) of technologists, or medical physicists. and terminology. Each facility shall this section can be given; or These records must be available for prepare a written report of the results of (B) ‘‘Incomplete: Need prior review by the MQSA inspectors. each mammographic examination mammograms for comparison.’’ Records of personnel no longer performed under its certificate. The Reserved for examinations where employed by the facility must be mammographic examination presented comparison with prior mammograms maintained at least until the next annual for interpretation must be in the original should be performed before an inspection has been completed and FDA mammographic modality in which it assessment category identified in has determined that the facility is in was performed, and must not consist of paragraph (c)(1)(iv)(A) through (G) of compliance with the MQSA personnel digital images produced through this section can be given. If this requirements. The facility shall provide copying or digitizing hardcopy original assessment category is used, a follow up copies of these personnel records to images. The mammography report shall report with an assessment category current or former interpreting include the following information: identified in paragraph (c)(1)(iv)(A) physicians, radiologic technologists, (i) The name of the patient and an through (E) of this section must be and medical physicists upon their additional patient identifier; issued within 30 calendar days of the

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00029 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules 11685

initial report whether or not comparison density is low, not high. Follow the paragraph (c)(4)(i) of this section. views can be obtained. recommendations in this letter, and talk Transfer of the mammograms and (vi) Overall assessment of breast to your healthcare provider about breast mammography reports must take place density, classified in one of the density, risks for breast cancer, and your within 15 calendar days of the facility following categories: individual situation.’’ receiving such request. The transferred (A) ‘‘The breasts are almost entirely (iv) If the mammography report mammograms must be in the fatty.’’ identifies the breast density as ‘‘The mammographic modality in which they (B) ‘‘There are scattered areas of breasts are heterogeneously dense, were produced, and cannot be produced fibroglandular density.’’ which may obscure small masses’’ or by copying or digitizing hardcopy (C) ‘‘The breasts are heterogeneously ‘‘The breasts are extremely dense, which originals. For digital mammograms or dense, which may obscure small lowers the sensitivity of digital breast tomosynthesis, if the masses.’’ mammography,’’ the lay summary shall examination is being transferred for (D) ‘‘The breasts are extremely dense, include ‘‘Some patients have high breast final interpretation purposes, the facility which lowers the sensitivity of tissue density (more glands than fat in must be able to provide the recipient mammography. the breasts), which makes it harder to with original digital images (vii) Recommendations made to the find breast cancer on a mammogram. electronically; healthcare provider about what Your breast tissue density is high. Some (iii) Shall upon request by, or on additional actions, if any, should be patients with high breast density may behalf of, the patient, provide copies of taken. All clinical questions raised by need other imaging tests in addition to mammograms and copies of the referring healthcare provider shall mammograms. Follow the mammogram reports to a medical be addressed in the report to the extent recommendations in this letter, and talk institution, a physician or healthcare possible, even if the assessment is to your healthcare provider about high provider of the patient, or to the patient negative or benign. breast density and how it relates to directly during the time specified in (2) Communication of mammography breast cancer risk, and your individual paragraph (c)(4)(i) of this section. results to the patients. Each facility shall situation.’’ Release of the copies must take place provide each patient a summary of the (3) * * * within 15 calendar days of the facility mammography report written in lay (ii) If the assessment is ‘‘Suspicious’’ receiving such request; terms within 30 calendar days of the or ‘‘Highly suggestive of malignancy,’’ (iv) Any fee charged to the patients for mammographic examination which the facility shall provide a written providing the services in paragraphs shall, at a minimum, include the name report of the mammographic (c)(4)(ii) or (c)(4)(iii) of this section shall of the patient, the name, address, and examination, including the items listed not exceed the documented costs telephone number of the facility in paragraph (c)(1) of this section, to the associated with this service; and performing the mammographic referring healthcare provider, or if the (v) Before a facility closes or ceases to examination and an assessment of breast referring healthcare provider is provide mammography services, it must density as described in paragraph unavailable, to a responsible designee of make arrangements for access by (c)(1)(vi) of this section. If the the referring healthcare provider within patients and healthcare providers to assessment of the mammography report 7 calendar days of the final their mammographic records. This is ‘‘Suspicious’’ or ‘‘Highly suggestive of interpretation of the mammograms but access may be provided by the malignancy,’’ the facility shall provide in no case later than 14 calendar days permanent transfer of mammographic the patient a summary of the from the date of the mammographic records to the patient or her healthcare mammography report written in lay examination. provider or the transfer of the language within 7 calendar days of the (4) Recordkeeping. Each facility that mammographic records to a facility or final interpretation of the mammograms performs mammograms: other entity that will provide access to but in no case later than 21 calendar (i) Shall (except as provided in patients and healthcare providers for the days from the date of the paragraph (c)(4)(ii) of this section) time periods specified in paragraph mammographic examination. maintain the mammograms and (i) Patients who do not name a mammography reports in a permanent (c)(4)(i) of this section. The facility must healthcare provider to receive the medical record of the patient for a notify its accreditation body and mammography report shall be sent the period of not less than 5 years, or not certification agency in writing of the report described in paragraph (c)(1) of less than 10 years if no additional arrangements it has made and must this section within 30 days, in addition mammograms of the patient are make reasonable efforts to notify all to the written notification of results in performed at the facility, or a longer affected patients. lay terms. period if mandated by State or local law. * * * * * (ii) Each facility that accepts patients Facilities shall implement policies and (f) * * * who do not have a healthcare provider procedures to minimize the possibility (1) General requirements. For the shall maintain a system for referring of loss of these records. The purposes of these requirements, a such patients to a healthcare provider mammograms must be retained in mammographic examination consisting when mammographically or clinically retrievable form in the mammographic of routine views of an asymptomatic indicated. modality in which they were produced. woman shall be termed a screening (iii) If the mammography report They cannot be produced by copying or mammogram, while a mammographic identifies the patient’s breast density as digitizing hardcopy originals. examination consisting of ‘‘The breasts are almost entirely fatty’’ (ii) Shall upon request by, or on individualized views of a woman with or ‘‘There are scattered areas of behalf of, the patient, permanently or breast symptoms, physical signs of fibroglandular density,’’ the lay temporarily transfer the original breast disease, or abnormal findings on summary shall include ‘‘Some patients mammograms and copies of the a screening mammogram shall be have high breast tissue density (more patient’s reports to a medical termed a diagnostic mammogram. Each glands than fat in the breasts), which institution, a physician or healthcare facility shall establish a system to makes it harder to find breast cancer on provider of the patient, or to the patient collect and review outcome data for all a mammogram. Your breast tissue directly during the time specified in mammographic examinations

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS 11686 Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Proposed Rules

performed, including follow up on the review, or other information, FDA or the (7) Has failed to comply with disposition of all positive mammograms State certification agency may reasonable requests of current or former and correlation of pathology results determine that the quality of facility personnel for records of their with the interpreting physician’s mammography performed by a facility, training or experience relevant to their mammography report. In addition, for whether or not certified under § 900.11, qualification under MQSA, in violation cases of breast cancer among patients was so inconsistent with the quality of § 900.12(a)(4). imaged at the facility that subsequently standards established in this part as to * * * * * become known to the facility, the present a significant risk to human Dated: March 21, 2018. facility shall promptly initiate follow up health. FDA or the State certification on surgical and/or pathology results and agency may require such a facility to Scott Gottlieb, review of the mammographic notify all patients who received Commissioner of Food and Drugs. examinations taken prior to the mammograms at the facility or those [FR Doc. 2019–05803 Filed 3–27–19; 8:45 am] diagnosis of a malignancy. Analysis of patients who are determined to be at BILLING CODE 4164–01–P these outcome data shall be made risk due to the quality of their individually and collectively for all mammography, and their referring interpreting physicians and, at a physicians or healthcare providers, of DEPARTMENT OF THE TREASURY minimum, shall consist of a the deficiencies and resulting potential determination of the following: harm, appropriate remedial measures, Internal Revenue Service (i) Positive predictive value—percent and such other relevant information as of patients with positive mammograms FDA or the State certification agency 26 CFR Part 1 who are diagnosed with breast cancer may require. Such notification shall [REG–143686–07] within 1 year of the date of the occur within a timeframe and in a mammographic examination. manner specified by FDA or the State RIN 1545–BH35 (ii) Cancer detection rate—of the certification agency. If the facility is unable or unwilling to perform such The Allocation of Consideration and patients initially examined with Allocation and Recovery of Basis in screening mammograms who receive an notification, FDA or the State certification agency may notify patients Transactions Involving Corporate assessment of ‘‘Incomplete: Need Stock or Securities; Withdrawal additional imaging evaluation,’’ and their referring physicians or other ‘‘Suspicious,’’ or ‘‘Highly suggestive of healthcare providers individually or AGENCY: Internal Revenue Service (IRS), malignancy’’ on the screening through the mass media. Treasury. ■ 6. In § 900.14, revise paragraph (a) mammogram or on a subsequent ACTION: Proposed rule; withdrawal. diagnostic mammogram, the number of introductory text and paragraphs (a)(3), patients who are diagnosed with breast (5), and (6), and add paragraph (a)(7) to SUMMARY: This document withdraws a cancer within 1 year of the date of the read as follows: notice of proposed rulemaking initial screening mammogram, § 900.14 Suspension or revocation of containing proposed regulations under expressed arithmetically as a ratio per certificates. numerous sections of the Internal 1,000 patients. (a) Except as provided in paragraph Revenue Code (Code). The proposed (iii) Recall rate—percentage of (b) of this section, FDA may suspend or regulations being withdrawn would screening mammograms given an revoke a certificate if FDA finds, after have provided guidance on the recovery assessment of ‘‘Incomplete: Need providing the owner or operator of the of stock basis in distributions of additional imaging evaluation.’’ facility with notice and opportunity for property made by a corporation to a * * * * * a hearing in accordance with part 16 of shareholder and certain transactions (j) Additional mammography review this chapter, that the facility, owner, treated as dividend-equivalents, as well and patient and referring physician operator, or any employee of the facility: as guidance regarding the determination of gain and the basis of stock or notification. * * * * * (1) If FDA or the State certification (3) Has failed to comply with securities received in certain agency believes that mammographic reasonable requests of FDA, the State transactions. The proposed regulations quality at a facility has been certification agency, or the accreditation being withdrawn would have affected compromised and may present a body for records, information, reports, shareholders and security holders of significant risk to human health, the or materials, including clinical images corporations. facility shall provide clinical images for an additional mammography review DATES: As of March 28, 2019, the notice and other relevant information, as under § 900.12(j), that FDA or the State of proposed rulemaking that was specified by FDA or the State certification agency believes are published in the Federal Register (74 certification agency, for review by the necessary to determine the continued FR 3509) on January 21, 2009, with accreditation body or the State eligibility of the facility for a certificate corrections published in the Federal certification agency. This additional or continued compliance with the Register (74 FR 9575) on March 5, 2009, mammography review will help FDA or standards of § 900.12; is withdrawn. the State certification agency determine * * * * * FOR FURTHER INFORMATION CONTACT: whether the facility is in compliance (5) Has violated or aided and abetted Kevin M. Jacobs at (202) 317–5332 or with this section and whether there is in the violation of any provision of or Aglaia Ovtchinnikova at (202) 317–6975 a need to notify affected patients, their regulation promulgated pursuant to 42 (neither a toll-free number). referring physicians or healthcare U.S.C. 263b; SUPPLEMENTARY INFORMATION: providers, and/or the public that there (6) Has failed to comply with prior is a significant risk to human health. sanctions imposed by FDA or the State Background (2) Based on the results of the certification agency under 42 U.S.C. On January 21, 2009, the Department additional mammography review, the 263b(h), including a directed plan of of the Treasury (Treasury Department) facility’s failure to comply with the correction or a patient and referring and the IRS published a notice of terms of the additional mammography physician notification; or proposed rulemaking (REG–143686–07)

VerDate Sep<11>2014 17:48 Mar 27, 2019 Jkt 247001 PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 E:\FR\FM\28MRP1.SGM 28MRP1 amozie on DSK9F9SC42PROD with PROPOSALS