[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)] [Notices] [Pages 42931-42934] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2019-17734] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0134] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 18, 2019. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0309. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Mammography Quality Standards Act Requirements--21 CFR Part 900 OMB Control Number 0910-0309--Extension The Mammography Quality Standards Act (Pub. L. 102-539) requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accreditation and certification bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. The intent of these regulations is to assure safe, reliable, and accurate mammography on a nationwide level. Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA-approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance, and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer complaint mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis. The following sections of Title 21 of the Code of Federal Regulations (CFR) are not included in the burden tables because they are considered usual and customary practice and were part of the standard of care prior to the implementation of the regulations; therefore, they resulted in no additional burden: 21 CFR 900.12(c)(1) and (3) and 900.3(f)(1). 21 CFR 900.24(c) was also not included in the burden tables because if a certifying State had its approval withdrawn, FDA would take [[Page 42932]] over certifying authority for the affected facilities. Because FDA already has all the certifying State's electronic records, there wouldn't be an additional reporting burden. We have rounded numbers in the ``Total Hours'' column in all three burden tables. (Where the number was a portion of 1 hour, it has been rounded to 1 hour. All other ``Total Hours'' have been rounded to the nearest whole number.) In the Federal Register of May 1, 2019 (84 FR 18548), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment that expressed general concern regarding the cost and quality of mammography equipment. However, the comment did not refer to any particular provision of the regulations or the information collection burden estimate. We note that in the Federal Register of March 28, 2019 (84 FR 11669), FDA published a proposed rule to update the mammography regulations. As part of the proposed rule, FDA prepared a Preliminary Economic Analysis of Impacts. Comments received on the proposed rule are currently being considered. FDA meets with its National Mammography Quality Assurance Advisory Committee (NMQAAC) annually. NMQAAC is made up of representatives of the mammography community, consumer and industry groups, and government. It is charged with advising FDA's mammography program on advances in mammography technology and procedures and on appropriate quality standards for mammography facilities. NMQAAC also discusses and comments on all guidances before they are made final. The meetings are open to the public and time is allotted for public statements on issues of concern in the mammography field. The chairperson may also call upon attendees to contribute to the committee discussions. FDA also meets or holds teleconferences several times a year with its approved accreditation bodies and State certification agencies to discuss issues of mutual concern. The Agency has also long enjoyed a good relationship with the Conference of State Radiation Program Directors (CRCPD), which is the professional organization of the State agencies concerned with radiation protection. The CRCPD has established a standing Mammography Committee, which meets with FDA mammography staff at least once a year. Finally, in recent years, FDA mammography staff have met several times with representatives of manufacturers working on the new applications of digital technology in mammography to resolve problems preventing the making of that technology generally available. FDA mammography staff have also worked with representatives of the manufacturers to develop quality assurance manuals for full field digital mammography units. FDA estimates the burden of this collection of information as follows: Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Activity/21 CFR section/FDA Number of Number of Total annual Average burden per Total hours Total capital operating and Form No. respondents responses per responses response \1\ costs maintenance respondent costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification of intent to 0.33 1 0.33 1....................... 1 .............. ............... become an AB--900.3(b)(1). Application for approval as 0.33 1 0.33 320..................... 106 $10,776 ............... an AB; full \2\-- 900.3(b)(3). Application for approval as 5 1 5 30...................... 150 .............. ............... an AB; limited \3\-- 900.3(b)(3). AB renewal of approval-- 1 1 1 15...................... 15 .............. ............... 900.3(c). AB application deficiencies-- 0.1 1 0.1 30...................... 3 .............. ............... 900.3(d)(2). AB resubmission of denied 0.1 1 0.1 30...................... 3 .............. ............... applications--900.3(d)(5). Letter of intent to 0.1 1 0.1 1....................... 1 .............. ............... relinquish accreditation authority--900.3(e). Summary report describing 330 1 330 7....................... 2,310 .............. $83,618 all facility assessments-- 900.4(f). AB reporting to FDA; 8,654 1 8,654 1....................... 8,654 .............. 4,663 facility \4\--900.4(h). AB reporting to FDA; AB \5\-- 5 1 5 10...................... 50 .............. ............... 900.4(h). AB financial records-- 1 1 1 16...................... 16 .............. ............... 900.4(i)(2). Former AB new application-- 0.1 1 0.1 60...................... 6 .............. ............... 900.6(c)(1). Reconsideration of 1 1 1 2....................... 2 .............. ............... accreditation following appeal--900.15(d)(3)(ii). Application for alternative 2 1 2 2....................... 4 .............. ............... standard--900.18(c). Alternative standard 10 1 10 1....................... 10 .............. ............... amendment--900.18(e). Certification agency 0.33 1 0.33 320..................... 106 32,327 224 application--900.21(b). Certification agency 0.1 1 0.1 30...................... 3 .............. ............... application deficiencies-- 900.21(c)(2). Certification electronic 5 200 1,000 0.083 (5 minutes)....... 83 .............. ............... data transmission-- 900.22(h). Changes to standards-- 2 1 2 30...................... 60 .............. 22 900.22(i). Certification agency minor 1 1 1 30...................... 30 .............. ............... deficiencies--900.24(b). Appeal of adverse action 0.2 1 0.2 16...................... 3 .............. ............... taken by FDA--900.25(a). Inspection fee exemption-- 700 1 700 0.25 (15 minutes)....... 175 .............. ............... Form FDA 3422. --------------------------------------------------------------------------------------------------------------------------- [[Page 42933]] Total................... .............. ............... .............. ........................ 11,791 43,103 88,527 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Total hours have been rounded. \2\ One-time burden. \3\ Refers to accreditation bodies applying to accredit specific full-field digital mammography units. \4\ Refers to the facility component of the burden for this requirement. \5\ Refers to the AB component of the burden for this requirement. Table 2--Estimated Annual Recordkeeping Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Average burden per Total hours Total capital operating and Activity/21 CFR section recordkeepers records per records recordkeeping \1\ costs maintenance recordkeeper costs -------------------------------------------------------------------------------------------------------------------------------------------------------- AB transfer of facility 0.1 1 0.1 0....................... 1 .............. ............... records--900.3(f)(1). Consumer complaints system; 5 1 5 1....................... 5 .............. ............... AB--900.4(g). Documentation of interpreting 87 1 87 8....................... 696 .............. ............... physician initial requirements--900.12(a)(1)(i )(B)(2). Documentation of interpreting 8,654 4 34,616 1....................... 34,616 .............. ............... physician personnel requirements--900.12(a)(4). Permanent medical record-- 8,654 1 8,654 1....................... 8,654 $30,171 ............... 900.12(c)(4). Procedures for cleaning 8,654 52 450,008 0.083 (5 minutes)....... 37,351 .............. ............... equipment--900.12(e)(13). Audit program--900.12(f)..... 8,654 1 8,654 16...................... 138,464 .............. ............... Consumer complaints system; 8,654 2 17,308 1....................... 17,308 .............. ............... facility--900.12(h)(2). Certification agency conflict 5 1 5 1....................... 5 .............. ............... of interest--900.22(a). Processes for suspension and 5 1 5 1....................... 5 .............. ............... revocation of certificates-- 900.22(d). Processes for appeals-- 5 1 5 1....................... 5 .............. ............... 900.22(e). Processes for additional 5 1 5 1....................... 5 .............. ............... mammography review-- 900.22(f). Processes for patient 3 1 3 1....................... 3 .............. $32 notifications--900.22(g). Evaluation of certification 5 1 5 20...................... 100 .............. ............... agency--900.23. Appeals--900.25(b)........... 5 1 5 1....................... 5 .............. ............... -------------------------------------------------------------------------------------------------------------------------- Total.................... .............. .............. .............. ........................ 237,223 30,171 32 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Total hours have been rounded. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Total hours operating and Activity/21 CFR section respondents disclosures disclosures Average burden per disclosure \2\ maintenance per respondent costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification of facilities that AB 0.1 1 0.1 200............................. 20 $54 relinquishes its accreditation-- 900.3(f)(2). Clinical images; facility \3\-- 2,885 1 2,885 1.44............................ 4,154 248,670 900.4(c), 900.11(b)(1), and 900.11(b)(2). Clinical images; AB \4\--900.4(c)... 5 1 5 416............................. 2,080 ............... Phantom images; facility \3\-- 2,885 1 2,885 0.72 (43 minutes)............... 2,077 ............... 900.4(d), 900.11(b)(1), and 900.11(b)(2). Phantom images; AB \4\--900.4(d).... 5 1 5 208............................. 1,040 ............... Annual equipment evaluation and 8,654 1 8,654 1............................... 8,654 9,325 survey; facility \3\--900.4(e), 900.11(b)(1), and 900.11(b)(2). Annual equipment evaluation and 5 1 5 1,730........................... 8,650 ............... survey; AB \4\--900.4(e). Provisional mammography facility 0 1 0 0.5 (30 minutes)................ 1 ............... certificate extension application-- 900.11(b)(3). Mammography facility certificate 312 1 312 5............................... 1,560 ............... reinstatement application-- 900.11(c). Lay summary of examination-- 8,654 5,085 44,055,590 0.083 (5 minutes)............... 3,652,464 25,861,265 900.12(c)(2). Lay summary of examination; patient 87 1 87 0.5 (30 minutes)................ 44 ............... refusal \5\--900.12(c)(2). Report of unresolved serious 20 1 20 1............................... 20 ............... complaints--900.12(h)(4). Information regarding compromised 20 1 20 200............................. 4,000 324 quality; facility \3\--900.12(j)(1). [[Page 42934]] Information regarding compromised 20 1 20 320............................. 6,400 646 quality; AB \4\--900.12(j)(1). Patient notification of serious 5 1 5 100............................. 500 20,878 risk--900.12(j)(2). Reconsideration of accreditation-- 5 1 5 2............................... 10 ............... 900.15(c). Notification of requirement to 0.4 1 0.4 200............................. 80 73 correct major deficiencies-- 900.24(a). Notification of loss of approval; 0.15 1 0.15 100............................. 15 27 major deficiencies--900.24(a)(2). Notification of probationary status-- 0.3 1 0.3 200............................. 60 55 900.24(b)(1). Notification of loss of approval; 0.15 1 0.15 100............................. 15 27 minor deficiencies--900.24(b)(3). ------------------------------------------------------------------------------------------------------------------- Total........................... .............. ............... .............. ................................ 3,691,842 26,141,344 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with the collection of information. \2\ Total hours have been rounded. \3\ Refers to the facility component of the burden for this requirement. \4\ Refers to the AB component of the burden for this requirement. \5\ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. FDA has adjusted the number of respondents for Sec. 900.3(c) ``AB renewal of approval'' to one. This adjustment resulted in a 14-hour increase to the hour-burden estimate. Additionally, we updated the capital costs and operating and maintenance costs by adjusting them for inflation since the last update to those estimates. This adjustment resulted in a $1,893,071 increase to the estimated capital and operating and maintenance costs ($24,410,106 previously; $26,303,177 current extension request). Dated: August 12, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-17734 Filed 8-16-19; 8:45 am] BILLING CODE 4164-01-P