Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements, 42931-42934 [2019-17734]

Download as PDF Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices security check procedures will be performed. For parking and security information, please refer to www.fda.gov/publicmeetinginfo. FOR FURTHER INFORMATION CONTACT: Rokhsareh Shahidzadeh, Office of Scientific Professional Development, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2383, Silver Spring, MD 20993, 301–796–8740, FDASciProDev@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The FDA Science Forum is held biennially to share with the public the unique scientific research and collaborative efforts of our 11,000 scientists and researchers. These scientists and researchers use novel science and technologies to inform FDA’s regulatory decision-making—and drive innovation. FDA scientific experts and nationally renowned scientists will speak on the eight topics of the upcoming FDA Science Forum, Transforming Health: Innovation in FDA Science. FDA’s Science Forum welcomes the public, industry, academia, patient advocates, sister Agencies, and current and potential collaborators, to learn about the Agency’s regulatory science—the type of science that is rarely undertaken by industry or academia, but that makes critical contributions to product quality and safety. jspears on DSK3GMQ082PROD with NOTICES II. Topics for Discussion at the Public Workshop Sessions in the two-day forum will highlight such areas as FDA research into new predictive tools for developing and evaluating therapeutics, advancing artificial intelligence, evaluating digital health devices, and novel methods of tackling critical public health challenges such as addiction. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following website: https://www.fda.gov/ scienceforum. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by September 6, 2019, at 5 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. VerDate Sep<11>2014 16:29 Aug 16, 2019 Jkt 247001 If you need special accommodations due to a disability, please contact Rokhsareh Shahidzadeh (see FOR FURTHER INFORMATION CONTACT) no later than September 4, 2019, by 5 p.m. Eastern Time. Streaming Webcast of the public workshop: This public workshop will also be webcast. To register, please visit the following website: https:// www.fda.gov/scienceforum. Participants interested in viewing via webcast must register by September 6, 2019, at 5 p.m. Eastern Time. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Dated: August 13, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–17703 Filed 8–16–19; 8:45 am] BILLING CODE 4164–01–P 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. 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0309. Also SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 42931 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, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 FDAapproved 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 E:\FR\FM\19AUN1.SGM 19AUN1 42932 Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices 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 jspears on DSK3GMQ082PROD with NOTICES Activity/21 CFR section/FDA Form No. Notification of intent to become an AB—900.3(b)(1). Application for approval as an AB; full 2—900.3(b)(3). Application for approval as an AB; limited 3—900.3(b)(3). AB renewal of approval—900.3(c) AB application deficiencies— 900.3(d)(2). AB resubmission of denied applications—900.3(d)(5). Letter of intent to relinquish accreditation authority—900.3(e). Summary report describing all facility assessments—900.4(f). AB reporting to FDA; facility 4— 900.4(h). AB reporting to FDA; AB 5— 900.4(h). AB financial records—900.4(i)(2) Former AB new application— 900.6(c)(1). Reconsideration of accreditation following appeal— 900.15(d)(3)(ii). Application for alternative standard—900.18(c). Alternative standard amendment—900.18(e). Certification agency application— 900.21(b). Certification agency application deficiencies—900.21(c)(2). Certification electronic data transmission—900.22(h). Changes to standards—900.22(i) Certification agency minor deficiencies—900.24(b). Appeal of adverse action taken by FDA—900.25(a). Inspection fee exemption—Form FDA 3422. VerDate Sep<11>2014 16:29 Aug 16, 2019 Number of responses per respondent Number of respondents Total annual responses Average burden per response Total hours 1 Total capital costs Total operating and maintenance costs 0.33 1 0.33 1 .................................. 1 ........................ .......................... 0.33 1 0.33 320 .............................. 106 $10,776 .......................... 5 1 5 30 ................................ 150 ........................ .......................... 1 0.1 1 1 1 0.1 15 ................................ 30 ................................ 15 3 ........................ ........................ .......................... .......................... 0.1 1 0.1 30 ................................ 3 ........................ .......................... 0.1 1 0.1 1 .................................. 1 ........................ .......................... 330 1 330 7 .................................. 2,310 ........................ $83,618 8,654 1 8,654 1 .................................. 8,654 ........................ 4,663 5 1 5 10 ................................ 50 ........................ .......................... 1 0.1 1 1 1 0.1 16 ................................ 60 ................................ 16 6 ........................ ........................ .......................... .......................... 1 1 1 2 .................................. 2 ........................ .......................... 2 1 2 2 .................................. 4 ........................ .......................... 10 1 10 1 .................................. 10 ........................ .......................... 0.33 1 0.33 320 .............................. 106 32,327 224 0.1 1 0.1 30 ................................ 3 ........................ .......................... 5 200 1,000 0.083 (5 minutes) ....... 83 ........................ .......................... 2 1 1 1 2 1 30 ................................ 30 ................................ 60 30 ........................ ........................ 22 .......................... 0.2 1 0.2 16 ................................ 3 ........................ .......................... 700 1 700 0.25 (15 minutes) ....... 175 ........................ .......................... Jkt 247001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\19AUN1.SGM 19AUN1 42933 Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Number of respondents Number of responses per respondent Total annual responses Average burden per response ........................ .......................... ........................ ..................................... Activity/21 CFR section/FDA Form No. Total ...................................... Total hours 1 11,791 Total operating and maintenance costs Total capital costs 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 Number of recordkeepers Activity/21 CFR section AB transfer of facility records— 900.3(f)(1). Consumer complaints system; AB—900.4(g). Documentation of interpreting physician initial requirements— 900.12(a)(1)(i)(B)(2). Documentation of interpreting physician personnel requirements— 900.12(a)(4). Permanent medical record— 900.12(c)(4). Procedures for cleaning equipment—900.12(e)(13). Audit program—900.12(f) ............... Consumer complaints system; facility—900.12(h)(2). Certification agency conflict of interest—900.22(a). Processes for suspension and revocation of certificates—900.22(d). Processes for appeals—900.22(e) Processes for additional mammography review—900.22(f). Processes for patient notifications—900.22(g). Evaluation of certification agency— 900.23. Appeals—900.25(b) ....................... Total ........................................ 1 Total Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 1 Total capital costs Total operating and maintenance costs 0.1 1 0.1 0 .................................. 1 ........................ .......................... 5 1 5 1 .................................. 5 ........................ .......................... 87 1 87 8 .................................. 696 ........................ .......................... 8,654 4 34,616 1 .................................. 34,616 ........................ .......................... 8,654 1 8,654 1 .................................. 8,654 $30,171 .......................... 8,654 52 450,008 0.083 (5 minutes) ....... 37,351 ........................ .......................... 8,654 8,654 1 2 8,654 17,308 16 ................................ 1 .................................. 138,464 17,308 ........................ ........................ .......................... .......................... 5 1 5 1 .................................. 5 ........................ .......................... 5 1 5 1 .................................. 5 ........................ .......................... 5 5 1 1 5 5 1 .................................. 1 .................................. 5 5 ........................ ........................ .......................... .......................... 3 1 3 1 .................................. 3 ........................ $32 5 1 5 20 ................................ 100 ........................ .......................... 5 1 5 1 .................................. 5 ........................ .......................... ........................ ........................ ........................ ..................................... 237,223 30,171 32 hours have been rounded. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 jspears on DSK3GMQ082PROD with NOTICES Notification of facilities that AB relinquishes its accreditation—900.3(f)(2). Clinical images; facility 3—900.4(c), 900.11(b)(1), and 900.11(b)(2). Clinical images; AB 4—900.4(c) ............................... Phantom images; facility 3—900.4(d), 900.11(b)(1), and 900.11(b)(2). Phantom images; AB 4—900.4(d) ............................ Annual equipment evaluation and survey; facility 3—900.4(e), 900.11(b)(1), and 900.11(b)(2). Annual equipment evaluation and survey; AB 4— 900.4(e). Provisional mammography facility certificate extension application—900.11(b)(3). Mammography facility certificate reinstatement application—900.11(c). Lay summary of examination—900.12(c)(2) ............ Lay summary of examination; patient refusal 5— 900.12(c)(2). Report of unresolved serious complaints— 900.12(h)(4). Information regarding compromised quality; facility 3—900.12(j)(1). VerDate Sep<11>2014 16:29 Aug 16, 2019 Number of disclosures per respondent Number of respondents Activity/21 CFR section Jkt 247001 PO 00000 Total annual disclosures Average burden per disclosure Total hours 2 Total operating and maintenance costs 0.1 1 0.1 200 .............................. 20 $54 2,885 1 2,885 1.44 ............................. 4,154 248,670 5 2,885 1 1 5 2,885 416 .............................. 0.72 (43 minutes) ....... 2,080 2,077 .......................... .......................... 5 8,654 1 1 5 8,654 208 .............................. 1 .................................. 1,040 8,654 .......................... 9,325 5 1 5 1,730 ........................... 8,650 .......................... 0 1 0 0.5 (30 minutes) ......... 1 .......................... 312 1 312 5 .................................. 1,560 .......................... 8,654 87 5,085 1 44,055,590 87 0.083 (5 minutes) ....... 0.5 (30 minutes) ......... 3,652,464 44 25,861,265 .......................... 20 1 20 1 .................................. 20 .......................... 20 1 20 200 .............................. 4,000 324 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\19AUN1.SGM 19AUN1 42934 Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Number of disclosures per respondent Number of respondents Activity/21 CFR section Information regarding compromised quality; AB 4— 900.12(j)(1). Patient notification of serious risk—900.12(j)(2) ...... Reconsideration of accreditation—900.15(c) ........... Notification of requirement to correct major deficiencies—900.24(a). Notification of loss of approval; major deficiencies—900.24(a)(2). Notification of probationary status—900.24(b)(1) .... Notification of loss of approval; minor deficiencies—900.24(b)(3). Total .................................................................. Total annual disclosures Average burden per disclosure Total hours 2 Total operating and maintenance costs 20 1 20 320 .............................. 6,400 646 5 5 0.4 1 1 1 5 5 0.4 100 .............................. 2 .................................. 200 .............................. 500 10 80 20,878 .......................... 73 0.15 1 0.15 100 .............................. 15 27 0.3 0.15 1 1 0.3 0.15 200 .............................. 100 .............................. 60 15 55 27 ........................ .......................... ........................ ..................................... 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 § 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Tick-Borne Disease Working Group Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public. For this meeting, the Working Group will receive updates from the eight subcommittees formed at the June 4, 2019, meeting and continue to focus on plans to develop the next report to the jspears on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:29 Aug 16, 2019 Jkt 247001 HHS Secretary and Congress on federal tick-borne activities and research, taking into consideration the 2018 report. The 2020 report will address a wide range of federal activities and research related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify gaps in tick-borne disease research; and provide recommendations to the HHS Secretary regarding changes or improvements to such activities and research. In developing the report, the TBDWG will solicit stakeholder input. DATES: The meeting will be online via webcast and will be held on September 12, 2019, from 8:30 a.m. to 5 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the website for the TBDWG at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/ 2019-9-12/ when this information becomes available. ADDRESSES: Members of the public may also attend the meeting via webcast. Instructions for attending the virtual meeting will be posted one week prior to the meeting at https://www.hhs.gov/ ash/advisory-committees/ tickbornedisease/meetings/2019-9-12/ index.html. FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E Switzer Building, 330 C Street SW, Suite L100, Washington, DC 20024. Email: tickbornedisease@ hhs.gov; Phone: 202–795–7697. SUPPLEMENTARY INFORMATION: The public will have an opportunity to present their views to the TBDWG PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 during the meeting’s public comment session or by submitting their views in writing. Comments should be pertinent to the meeting discussion. Persons who wish to provide verbal or written public comment should review instructions at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/ 2019-9-12/ and respond by midnight Wednesday, September 4, 2019, ET. Verbal comments will be limited to three minutes each to accommodate as many speakers as possible during the 30 minute session. Written public comments will be accessible to the TBDWG members and public on the TBDWG web page prior to the meeting. Background and Authority: The TickBorne Disease Working Group was established on August 10, 2017, in accordance with Section 2062 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to provide expertise and review federal efforts related to tickborne diseases to help ensure interagency coordination and minimize overlap, examine research priorities, and identify and address unmet needs. The TBDWG is required to submit a report to the HHS Secretary and Congress on their findings and any recommendations for the federal response to tick-borne disease every two years. Dated: August 6, 2019. James Berger, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Advisor for Blood and Tissue Policy, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2019–17689 Filed 8–16–19; 8:45 am] BILLING CODE 4150–28–P E:\FR\FM\19AUN1.SGM 19AUN1

Agencies

[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]


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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


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