42931 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. 
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. 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 
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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. 
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 oira_
submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov. 
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 
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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—E STIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1 
Activity/21 CFR section/FDA 
Form No. Number of 
respondents Number of 
responses per 
respondent Total annual 
responses Average burden 
per response Total hours1 Total 
capital costs Total 
operating and 
maintenance 
costs 
Notification of intent to become 
an AB—900.3(b)(1).0.33 1 0.33 1 .................................. 1 ........................ ..........................
Application for approval as an 
AB; full2—900.3(b)(3).0.33 1 0.33 320 .............................. 106 $10,776 ..........................
Application for approval as an 
AB; limited3—900.3(b)(3).5 1 5 30 ................................ 150 ........................ ..........................
AB renewal of approval—900.3(c) 1 1 1 15 ................................ 15 ........................ ..........................
AB application deficiencies— 
900.3(d)(2).0.1 1 0.1 30 ................................ 3 ........................ ..........................
AB resubmission of denied appli-
cations—900.3(d)(5).0.1 1 0.1 30 ................................ 3 ........................ ..........................
Letter of intent to relinquish ac-
creditation authority—900.3(e).0.1 1 0.1 1 .................................. 1 ........................ ..........................
Summary report describing all fa-
cility assessments—900.4(f).330 1 330 7 .................................. 2,310 ........................ $83,618 
AB reporting to FDA; facility4— 
900.4(h).8,654 1 8,654 1 .................................. 8,654 ........................ 4,663 
AB reporting to FDA; AB5— 
900.4(h).5 1 5 10 ................................ 50 ........................ ..........................
AB financial records—900.4(i)(2) 1 1 1 16 ................................ 16 ........................ ..........................
Former AB new application— 
900.6(c)(1).0.1 1 0.1 60 ................................ 6 ........................ ..........................
Reconsideration of accreditation 
following appeal— 
900.15(d)(3)(ii).1 1 1 2 .................................. 2 ........................ ..........................
Application for alternative stand-
ard—900.18(c).2 1 2 2 .................................. 4 ........................ ..........................
Alternative standard amend-
ment—900.18(e).10 1 10 1 .................................. 10 ........................ ..........................
Certification agency application— 
900.21(b).0.33 1 0.33 320 .............................. 106 32,327 224 
Certification agency application 
deficiencies—900.21(c)(2).0.1 1 0.1 30 ................................ 3 ........................ ..........................
Certification electronic data trans-
mission—900.22(h).5 200 1,000 0.083 (5 minutes) ....... 83 ........................ ..........................
Changes to standards—900.22(i) 2 1 2 30 ................................ 60 ........................ 22 
Certification agency minor defi-
ciencies—900.24(b).1 1 1 30 ................................ 30 ........................ ..........................
Appeal of adverse action taken 
by FDA—900.25(a).0.2 1 0.2 16 ................................ 3 ........................ ..........................
Inspection fee exemption—Form 
FDA 3422.700 1 700 0.25 (15 minutes) ....... 175 ........................ ..........................
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TABLE 3—E STIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1—Continued 
Activity/21 CFR section/FDA 
Form No. Number of 
respondents Number of 
responses per 
respondent Total annual 
responses Average burden 
per response Total hours1 Total 
capital costs Total 
operating and 
maintenance 
costs 
Total ...................................... ........................ .......................... ........................ .......... ........................... 11,791 43,103 88,527 
1Total hours have been rounded. 
2One-time burden. 
3Refers to accreditation bodies applying to accredit specific full-field digital mammography units. 
4Refers to the facility component of the burden for this requirement. 
5Refers to the AB component of the burden for this requirement. 
TABLE 2—E STIMATED ANNUAL RECORDKEEPING BURDEN  
Activity/21 CFR section Number of 
recordkeepers Number of 
records per 
recordkeeper Total annual 
records Average burden 
per recordkeeping Total hours1 Total 
capital costs Total 
operating and 
maintenance 
costs 
AB transfer of facility records— 
900.3(f)(1).0.1 1 0.1 0 .................................. 1 ........................ ..........................
Consumer complaints system; 
AB—900.4(g).5 1 5 1 .................................. 5 ........................ ..........................
Documentation of interpreting phy-
sician initial requirements— 
900.12(a)(1)(i)(B)(2).87 1 87 8 .................................. 696 ........................ ..........................
Documentation of interpreting phy-
sician personnel requirements— 900.12(a)(4).8,654 4 34,616 1 .................................. 34,616 ........................ ..........................
Permanent medical record— 
900.12(c)(4).8,654 1 8,654 1 .................................. 8,654 $30,171 ..........................
Procedures for cleaning equip-
ment—900.12(e)(13).8,654 52 450,008 0.083 (5 minutes) ....... 37,351 ........................ ..........................
Audit program—900.12(f) ............... 8,654 1 8,654 16 ................................ 138,464 ........................ ......... .................
Consumer complaints system; fa-
cility—900.12(h)(2).8,654 2 17,308 1 .................................. 17,308 ........................ ..........................
Certification agency conflict of in-
terest—900.22(a).5 1 5 1 .................................. 5 ........................ ..........................
Processes for suspension and rev-
ocation of certificates—900.22(d).5 1 5 1 .................................. 5 ........................ ..........................
Processes for appeals—900.22(e) 5 1 5 1 .................................. 5 ........................ ..........................
Processes for additional mammog-
raphy review—900.22(f).5 1 5 1 .................................. 5 ........................ ..........................
Processes for patient notifica-
tions—900.22(g).3 1 3 1 .................................. 3 ........................ $32 
Evaluation of certification agency— 
900.23.5 1 5 20 ................................ 100 ........................ ..........................
Appeals—900.25(b) ....................... 5 1 5 1 .................................. 5 ........................ .................... ......
Total ........................................ ........................ ........................ ........................ .......... ........................... 237,223 30,171 32 
1Total hours have been rounded. 
TABLE 3—E STIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1 
Activity/21 CFR section Number of 
respondents Number of 
disclosures 
per respondent Total annual 
disclosures Average burden 
per disclosure Total hours2 Total 
operating and 
maintenance 
costs 
Notification of facilities that AB relinquishes its ac-
creditation—900.3(f)(2).0.1 1 0.1 200 .............................. 20 $54 
Clinical images; facility3—900.4(c), 900.11(b)(1), 
and 900.11(b)(2).2,885 1 2,885 1.44 ............................. 4,154 248,670 
Clinical images; AB4—900.4(c) ............................... 5 1 5 416 .............................. 2,080 ..........................
Phantom images; facility3—900.4(d), 900.11(b)(1), 
and 900.11(b)(2).2,885 1 2,885 0.72 (43 minutes) ....... 2,077 ..........................
Phantom images; AB4—900.4(d) ............................ 5 1 5 208 .............................. 1,040 ..........................
Annual equipment evaluation and survey; facil-
ity3—900.4(e), 900.11(b)(1), and 900.11(b)(2).8,654 1 8,654 1 .................................. 8,654 9,325 
Annual equipment evaluation and survey; AB4— 
900.4(e).5 1 5 1,730 ........................... 8,650 ..........................
Provisional mammography facility certificate exten-
sion application—900.11(b)(3).0 1 0 0.5 (30 minutes) ......... 1 ..........................
Mammography facility certificate reinstatement ap-
plication—900.11(c).312 1 312 5 .................................. 1,560 ..........................
Lay summary of examination—900.12(c)(2) ............ 8,654 5,085 44,055,590 0.083 (5 minutes) ....... 3,652,464 25,861,265 
Lay summary of examination; patient refusal5— 
900.12(c)(2).87 1 87 0.5 (30 minutes) ......... 44 ..........................
Report of unresolved serious complaints— 
900.12(h)(4).20 1 20 1 .................................. 20 ..........................
Information regarding compromised quality; facil-
ity3—900.12(j)(1).20 1 20 200 .............................. 4,000 324 
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TABLE 3—E STIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1—Continued 
Activity/21 CFR section Number of 
respondents Number of 
disclosures 
per respondent Total annual 
disclosures Average burden 
per disclosure Total hours2 Total 
operating and 
maintenance 
costs 
Information regarding compromised quality; AB4— 
900.12(j)(1).20 1 20 320 .............................. 6,400 646 
Patient notification of serious risk—900.12(j)(2) ...... 5 1 5 100 .............................. 500 20,878 
Reconsideration of accreditation—900.15(c) ........... 5 1 5 2 .................................. 10 ..........................
Notification of requirement to correct major defi-
ciencies—900.24(a).0.4 1 0.4 200 .............................. 80 73 
Notification of loss of approval; major defi-
ciencies—900.24(a)(2).0.15 1 0.15 100 .............................. 15 27 
Notification of probationary status—900.24(b)(1) .... 0.3 1 0.3 200 .............................. 60 55 
Notification of loss of approval; minor defi-
ciencies—900.24(b)(3).0.15 1 0.15 100 .............................. 15 27 
Total .................................................................. ........................ .......................... ...... .................. ..................................... 3,691,842 26,141,344 
1There are no capital costs associated with the collection of information. 
2Total hours have been rounded. 
3Refers to the facility component of the burden for this requirement. 
4Refers to the AB component of the burden for this requirement. 
5Refers 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 
AGENCY : Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and Human Services. 
ACTION : Notice. 
SUMMARY : 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 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/advisory- committees/tickbornedisease/meetings/ 2019-9-12/index.html 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 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/advisory- committees/tickbornedisease/meetings/ 2019-9-12/index.html 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 Tick- 
Borne 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 tick- borne 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 
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