2019-08784. Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.

    DATES:

    Submit either electronic or written comments on the collection of information by July 1, 2019.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 1, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2013-N-0134 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

    Docket: For access to the docket to read background documents or the Start Printed Page 18549electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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    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.

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    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    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 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.)

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden

    Activity/21 CFR section/FDA Form No.Number of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours 1Total capital costsTotal operating and maintenance costs
    Notification of intent to become an AB—900.3(b)(1)0.3310.3311
    Application for approval as an AB; full 2—900.3(b)(3)0.3310.33320106$10,776
    Application for approval as an AB; limited 3—900.3(b)(3)51530150
    AB renewal of approval—900.3(c)1111515
    AB application deficiencies—900.3(d)(2)0.110.1303
    AB resubmission of denied applications—900.3(d)(5)0.110.1303
    Letter of intent to relinquish accreditation authority—900.3(e)0.110.111
    Summary report describing all facility assessments—900.4(f)330133072,310$83,618
    AB reporting to FDA; facility 4—900.4(h)8,65418,65418,6544,663
    AB reporting to FDA; AB 5—900.4(h)5151050
    AB financial records—900.4(i)(2)1111616
    Former AB new application—900.6(c)(1)0.110.1606
    Reconsideration of accreditation following appeal—900.15(d)(3)(ii)11122
    Application for alternative standard—900.18(c)21224
    Alternative standard amendment—900.18(e)10110110
    Certification agency application—900.21(b)0.3310.3332010632,327224
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    Certification agency application deficiencies—900.21(c)(2)0.110.1303
    Certification electronic data transmission—900.22(h)520010000.083 (5 minutes)83
    Changes to standards—900.22(i)212306022
    Certification agency minor deficiencies—900.24(b)1113030
    Appeal of adverse action taken by FDA—900.25(a)0.210.2163
    Inspection fee exemption—Form FDA 342270017000.25 (15 minutes)175
    Total11,79143,10388,527
    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

    Activity/21 CFR sectionNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hours 1Total capital costsTotal operating and maintenance costs
    AB transfer of facility records—900.3(f)(1)0.110.101
    Consumer complaints system; AB—900.4(g)51515
    Documentation of interpreting physician initial requirements—900.12(a)(1)(i)(B)(2)871878696
    Documentation of interpreting physician personnel requirements—900.12(a)(4)8,654434,616134,616
    Permanent medical record—900.12(c)(4)8,65418,65418,654$30,171
    Procedures for cleaning equipment—900.12(e)(13)8,65452450,0080.083 (5 minutes)37,351
    Audit program—900.12(f)8,65418,65416138,464
    Consumer complaints system; facility—900.12(h)(2)8,654217,308117,308
    Certification agency conflict of interest—900.22(a)51515
    Processes for suspension and revocation of certificates—900.22(d)51515
    Processes for appeals—900.22(e)51515
    Processes for additional mammography review—900.22(f)51515
    Processes for patient notifications—900.22(g)31313$32
    Evaluation of certification agency—900.2351520100
    Appeals—900.25(b)51515
    Total237,22330,17132
    1 Total hours have been rounded.

    Table 3—Estimated Annual Third-Party Disclosure Burden 1

    Activity/21 CFR sectionNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hours 2Total operating and maintenance costs
    Notification of facilities that AB relinquishes its accreditation—900.3(f)(2)0.110.120020$54
    Clinical images; facility 3—900.4(c), 900.11(b)(1), and 900.11(b)(2)2,88512,8851.444,154248,670
    Clinical images; AB 4—900.4(c)5154162,080
    Phantom images; facility 3—900.4(d), 900.11(b)(1), and 900.11(b)(2)2,88512,8850.72 (43 minutes)2,077
    Phantom images; AB 4—900.4(d)5152081,040
    Annual equipment evaluation and survey; facility 3—900.4(e), 900.11(b)(1), and 900.11(b)(2)8,65418,65418,6549,325
    Annual equipment evaluation and survey; AB 4—900.4(e)5151,7308,650
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    Provisional mammography facility certificate extension application—900.11(b)(3)0100.5 (30 minutes)1
    Mammography facility certificate reinstatement application—900.11(c)312131251,560
    Lay summary of examination—900.12(c)(2)8,6545,08544,055,5900.083 (5 minutes)3,652,46425,861,265
    Lay summary of examination; patient refusal 5—900.12(c)(2)871870.5 (30 minutes)44
    Report of unresolved serious complaints—900.12(h)(4)20120120
    Information regarding compromised quality; facility 3—900.12(j)(1)201202004,000324
    Information regarding compromised quality; AB 4—900.12(j)(1)201203206,400646
    Patient notification of serious risk—900.12(j)(2)51510050020,878
    Reconsideration of accreditation—900.15(c)515210
    Notification of requirement to correct major deficiencies—900.24(a)0.410.42008073
    Notification of loss of approval; major deficiencies—900.24(a)(2)0.1510.151001527
    Notification of probationary status—900.24(b)(1)0.310.32006055
    Notification of loss of approval; minor deficiencies—900.24(b)(3)0.1510.151001527
    Total3,691,84226,141,344
    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).

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    Dated: April 24, 2019.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

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    [FR Doc. 2019-08784 Filed 4-30-19; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
05/01/2019
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2019-08784
Dates:
Submit either electronic or written comments on the collection of information by July 1, 2019.
Pages:
18548-18551 (4 pages)
Docket Numbers:
Docket No. FDA-2013-N-0134
PDF File:
2019-08784.Pdf
Supporting Documents:
» MQSA Ref 34 Eastern Research Group Inc. - Baseline Quality Measures
» MQSA Ref 31 - ACR BI-RADS pp 7-8
» MQSA Ref 27 - Ho 2014 AJR
» MQSA Ref 22 - Transcript of Sept 29 2006 - 2nd part
» MQSA Ref 22 - Transcript of Sept 28 2006 - 3rd part
» MQSA Ref 22 - Transcript of Sept 28 2006 - 2nd part
» MQSA Ref 21 - Dense Breast Info website
» MQSA Ref 20 - NMQAAC summary 2011
» MQSA Ref 19 - Berg 2008 JAMA
» MQSA Ref 17 - Kolb 2002 Radiol