81 FR 55463 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 161 (August 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 161 (August 19, 2016)
| Page Range | 55463-55466 | |
| FR Document | 2016-19808 |
[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)] [Notices] [Pages 55463-55466] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19808] ----------------------------------------------------------------------- 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 19, 2016. 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North,10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [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). Section 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.) [[Page 55464]] We do not expect any respondents for Sec. 900.3(c) because all four ABs are approved until April 2020. In the Federal Register of June 8, 2016 (81 FR 36924), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Average Total operating and Activity/21 CFR Section/Form FDA No. Number of responses Total annual burden per Total hours capital maintenance respondents per responses response \1\ costs (in costs (in respondent dollars) dollars) -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification of intent to become an AB--900.3(b)(1).. 0.33 1 0.33 1 1 ........... .............. Application for approval as an AB; full \2\-- 0.33 1 0.33 320 106 10,000 .............. 900.3(b)(3)......................................... Application for approval as an AB; limited \3\-- 5 1 5 30 150 ........... .............. 900.3(b)(3)......................................... AB renewal of approval--900.3(c)..................... 0 1 0 15 1 ........... .............. AB application deficiencies--900.3(d)(2)............. 0.1 1 0.1 30 3 ........... .............. AB resubmission of denied applications--900.3(d)(5).. 0.1 1 0.1 30 3 ........... .............. Letter of intent to relinquish accreditation 0.1 1 0.1 1 1 ........... .............. authority--900.3(e)................................. Summary report describing all facility assessments-- 330 1 330 7 2,310 ........... 77,600 900.4(f)............................................ AB reporting to FDA; facility \4\--900.4(h).......... 8,654 1 8,654 1 8,654 ........... 4,327 AB reporting to FDA; AB \5\--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-- 1 1 1 2 2 ........... .............. 900.15(d)(3)(ii).................................... Application for alternative standard--900.18(c)...... 2 1 2 2 4 ........... .............. Alternative standard amendment--900.18(e)............ 10 1 10 1 10 ........... .............. Certification agency application--900.21(b).......... 0.33 1 0.33 320 106 ........... 208 Certification agency application deficiencies-- 0.1 1 0.1 30 3 ........... .............. 900.21(c)(2)........................................ Certification electronic data transmission--900.22(h) 5 200 1000 0.083 83 30,000 .............. Changes to standards--900.22(i)...................... 2 1 2 30 60 ........... 20 Certification agency minor deficiencies--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 0.25 175 ........... .............. -------------------------------------------------------------------------------------------------- Total............................................ ............ ............ ............ ............. 11,777 40,000 82,155 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 Average Total capital operating and Activity/21 CFR Section Number of records per Total annual burden per Total hours costs (in maintenance recordkeepers recordkeeper records recordkeeping \1\ dollars) costs (in dollars) -------------------------------------------------------------------------------------------------------------------------------------------------------- AB transfer of facility records-- 0.1 1 0.1 0 1 .............. .............. 900.3(f)(1)............................... [[Page 55465]] Consumer complaints system; AB--900.4(g)... 5 1 5 1 5 .............. .............. Documentation of interpreting physician 87 1 87 8 696 .............. .............. initial requirements-- 900.12(a)(1)(i)(B)(2)..................... Documentation of interpreting physician 8,654 4 34,616 1 34,616 .............. .............. personnel requirements--900.12(a)(4)...... Permanent medical record--900.12(c)(4)..... 8,654 1 8,654 1 8,654 28,000 .............. Procedures for cleaning equipment-- 8,654 52 450,008 0.083 37,351 .............. .............. 900.12(e)(13)............................. Audit program--900.12(f)................... 8,654 1 8,654 16 138,464 .............. .............. Consumer complaints system; facility-- 8,654 2 17,308 1 17,308 .............. .............. 900.12(h)(2).............................. Certification agency conflict of interest-- 5 1 5 1 5 .............. .............. 900.22(a)................................. Processes for suspension and revocation of 5 1 5 1 5 .............. .............. certificates--900.22(d)................... Processes for appeals--900.22(e)........... 5 1 5 1 5 .............. .............. Processes for additional mammography 5 1 5 1 5 .............. .............. review--900.22(f)......................... Processes for patient notifications-- 3 1 3 1 3 .............. 30 900.22(g)................................. Evaluation of certification agency--900.23. 5 1 5 20 100 .............. .............. Appeals--900.25(b)......................... 5 1 5 1 5 .............. .............. ------------------------------------------------------------------------------------------------------------ Total.................................. ............. .............. ............. ............. 237,223 28,000 30 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Total hours have been rounded. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Average operating and Activity/21 CFR Section Number of disclosures per Total annual burden per Total hours maintenance respondents respondent disclosures disclosure \2\ costs (in dollars) -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification of facilities that AB relinquishes its 0.1 1 0.1 200 20 50 accreditation--900.3(f)(2)................................ Clinical images; facility \3\--900.4(c), 900.11(b)(1) and 2,885 1 2,885 1.44 4,154 .............. (2)....................................................... Clinical images; AB \4\--900.4(c).......................... 5 1 5 416 2,080 230,773 Phantom images; facility \3\--900.4(d), 900.11(b)(1) and 2,885 1 2,885 0.72 2,077 .............. (2)....................................................... Phantom images; AB \4\--900.4(d)........................... 5 1 5 208 1,040 .............. Annual equipment evaluation and survey; facility \3\-- 8,654 1 8,654 1 8,654 8,654 900.4(e), 900.11(b)(1) and (2)............................ Annual equipment evaluation and survey; AB \4\--900.4(e)... 5 1 5 1,730 8,650 .............. Provisional mammography facility certificate extension 0 1 0 0.5 1 .............. application--900.11(b)(3)................................. [[Page 55466]] Mammography facility certificate reinstatement application-- 312 1 312 5 1,560 24,000,000 900.11(c)................................................. Lay summary of examination--900.12(c)(2)................... 8,654 5,085 44,055,590 0.083 3,652,464 .............. Lay summary of examination; patient refusal \5\-- 87 1 87 0.5 44 .............. 900.12(c)(2).............................................. Report of unresolved serious complaints--900.12(h)(4)...... 20 1 20 1 20 .............. Information regarding compromised quality; facility \3\-- 20 1 20 200 4,000 300 900.12(j)(1).............................................. Information regarding compromised quality; AB \4\-- 20 1 20 320 6,400 600 900.12(j)(1).............................................. Patient notification of serious risk--900.12(j)(2)......... 5 1 5 100 500 19,375 Reconsideration of accreditation--900.15(c)................ 5 1 5 2 10 .............. Notification of requirement to correct major deficiencies-- 0.4 1 0.4 200 80 68 900.24(a)................................................. Notification of loss of approval; major deficiencies-- 0.15 1 0.15 100 15 25.50 900.24(a)(2).............................................. Notification of probationary status--900.24(b)(1).......... 0.3 1 0.3 200 60 51 Notification of loss of approval; minor deficiencies-- 0.15 1 0.15 100 15 25.50 900.24(b)(3).............................................. -------------------------------------------------------------------------------------------- Total.................................................. ............ ............... ............. ............. 3,691,842 24,259,921 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this 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. Dated: August 15, 2016. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. [FR Doc. 2016-19808 Filed 8-18-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices 55463
(21 U.S.C. 381(e)(2)) provides for the obtaining written authorization from the Agency of the United States. The
exportation of an unapproved device foreign government is to accept a respondents to this collection of
under certain circumstances if the notarized certification from a information are companies that seek to
exportation is not contrary to the public responsible company official in the export medical devices. FDA’s estimate
health and safety and it has the approval United States that the product is not in of the reporting burden is based on the
of the foreign country to which it is conflict with the foreign country’s laws. experience of FDA’s medical device
intended for export. Requesters This certification must include a program personnel.
communicate (either directly or through statement acknowledging that the
a business associate in the foreign responsible company official making the In the Federal Register of April 22,
country) with a representative of the certification is subject to the provisions 2016 (81 FR 23720), FDA published a
foreign government to which they seek of 18 U.S.C. 1001. This statutory 60-day notice requesting public
exportation, and written authorization provision makes it a criminal offense to comment on the proposed collection of
must be obtained from the appropriate knowingly and willingly make a false or information. No comments were
office within the foreign government fraudulent statement, or make or use a received.
approving the importation of the false document, in any manner within FDA estimates the burden of this
medical device. An alternative to the jurisdiction of a department or collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total oper-
Average
Number of responses Total annual ating and
Activity/Section of FD&C Act burden per Total hours
respondents per responses maintenance
response
respondent costs
Foreign letter of approval—section 801(e)(2) ........ 38 1 38 3 114 $9,500
1 There are no capital costs associated with this collection of information.
Dated: August 15, 2016. submission@omb.eop.gov. All information showing that they meet the
Peter Lurie, comments should be identified with the equipment, personnel, quality
Associate Commissioner for Public Health OMB control number 0910–0309. Also assurance, and quality control
Strategy and Analysis. include the FDA docket number found standards, and have a medical reporting
[FR Doc. 2016–19807 Filed 8–18–16; 8:45 am] in brackets in the heading of this and recordkeeping program, a medical
BILLING CODE 4164–01–P document. outcomes audit program, and a
FOR FURTHER INFORMATION CONTACT: FDA consumer complaint mechanism. On the
PRA Staff, Office of Operations, Food basis of this accreditation, facilities are
DEPARTMENT OF HEALTH AND and Drug Administration, Three White then certified by FDA or an FDA-
HUMAN SERVICES Flint North,10A–12M, 11601 approved State certification agency and
Landsdown St., North Bethesda, MD must prominently display their
Food and Drug Administration
20852, PRAStaff@fda.hhs.gov. certificate. These actions are taken to
[Docket No. FDA–2013–N–0134] SUPPLEMENTARY INFORMATION: In ensure safe, accurate, and reliable
compliance with 44 U.S.C. 3507, FDA mammography on a nationwide basis.
Agency Information Collection has submitted the following proposed The following sections of Title 21 of
Activities; Submission for Office of collection of information to OMB for
Management and Budget Review; the Code of Federal Regulations (CFR)
review and clearance.
Comment Request; Mammography are not included in the burden tables
Quality Standards Act Requirements Mammography Quality Standards Act because they are considered usual and
Requirements—21 CFR Part 900, OMB customary practice and were part of the
AGENCY: Food and Drug Administration, Control Number 0910–0309—Extension standard of care prior to the
HHS. The Mammography Quality Standards implementation of the regulations.
ACTION: Notice. Act (Pub. L. 102–539) requires the Therefore, they resulted in no additional
establishment of a Federal certification burden: 21 CFR 900.12(c)(1) and (3) and
SUMMARY: The Food and Drug and inspection program for 900.3(f)(1). Section 900.24(c) was also
Administration (FDA) is announcing mammography facilities; regulations not included in the burden tables
that a proposed collection of and standards for accreditation and because if a certifying State had its
information has been submitted to the certification bodies for mammography approval withdrawn, FDA would take
Office of Management and Budget facilities; and standards for over certifying authority for the affected
(OMB) for review and clearance under mammography equipment, personnel,
the Paperwork Reduction Act of 1995. facilities. Because FDA already has all
and practices, including quality the certifying State’s electronic records,
DATES: Fax written comments on the assurance. The intent of these there wouldn’t be an additional
collection of information by September regulations is to assure safe, reliable, reporting burden.
19, 2016. and accurate mammography on a
mstockstill on DSK3G9T082PROD with NOTICES
ADDRESSES: To ensure that comments on nationwide level. Under the regulations, We have rounded numbers in the
the information collection are received, as a first step in becoming certified, ‘‘Total Hours’’ column in all three
OMB recommends that written mammography facilities must become burden tables. (Where the number was
comments be faxed to the Office of accredited by an FDA-approved a portion of 1 hour, it has been rounded
Information and Regulatory Affairs, accreditation body (AB). This requires to 1 hour. All other ‘‘Total Hours’’ have
OMB, Attn: FDA Desk Officer, FAX: undergoing a review of their clinical been rounded to the nearest whole
202–395–7285, or emailed to oira_ images and providing the AB with number.)
VerDate Sep<11>2014 18:08 Aug 18, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\19AUN1.SGM 19AUN1](https://thefederalregister.org/doc/81_FR_55624/page/1.svg)
![55466 Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Total operating
Number of Average and
Number of Total annual
Activity/21 CFR Section disclosures per burden per Total hours 2 maintenance
respondents disclosures
respondent disclosure costs
(in dollars)
Mammography facility certificate rein-
statement application—900.11(c) ......... 312 1 312 5 1,560 24,000,000
Lay summary of examination—
900.12(c)(2) .......................................... 8,654 5,085 44,055,590 0.083 3,652,464 ........................
Lay summary of examination; patient re-
fusal 5—900.12(c)(2) ............................. 87 1 87 0.5 44 ........................
Report of unresolved serious com-
plaints—900.12(h)(4) ............................ 20 1 20 1 20 ........................
Information regarding compromised qual-
ity; facility 3—900.12(j)(1) ..................... 20 1 20 200 4,000 300
Information regarding compromised qual-
ity; AB 4—900.12(j)(1) ........................... 20 1 20 320 6,400 600
Patient notification of serious risk—
900.12(j)(2) ........................................... 5 1 5 100 500 19,375
Reconsideration of accreditation—
900.15(c) .............................................. 5 1 5 2 10 ........................
Notification of requirement to correct
major deficiencies—900.24(a) .............. 0.4 1 0.4 200 80 68
Notification of loss of approval; major de-
ficiencies—900.24(a)(2) ....................... 0.15 1 0.15 100 15 25.50
Notification of probationary status—
900.24(b)(1) .......................................... 0.3 1 0.3 200 60 51
Notification of loss of approval; minor de-
ficiencies—900.24(b)(3) ....................... 0.15 1 0.15 100 15 25.50
Total .................................................. ...................... .......................... ........................ ........................ 3,691,842 24,259,921
1 There are no capital costs associated with this 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.
Dated: August 15, 2016. Services (Secretary) concerning policy, plan to participate on the conference
Peter Lurie, program development, and other call and webinar should notify Dr.
Associate Commissioner for Public Health matters of significance related to Weiss at least 3 days prior to the
Strategy and Analysis. interdisciplinary, community-based meeting, using the address and phone
[FR Doc. 2016–19808 Filed 8–18–16; 8:45 am] training grant programs authorized number below. Members of the public
BILLING CODE 4164–01–P under sections 750—759, Title VII, Part will have the opportunity to provide
D of the Public Health Service Act, as comments. Interested parties should
amended by the Affordable Care Act. refer to the meeting subject as the HRSA
DEPARTMENT OF HEALTH AND The Advisory Committee focuses on the Advisory Committee on
HUMAN SERVICES targeted program areas and/or Interdisciplinary, Community-Based
disciplines for Area Health Education Linkages.
Health Resources and Service Centers, geriatrics, allied health, • The conference call-in number is 1–
Administration chiropractic, podiatric medicine, social 800–619–2521. The passcode is:
work, graduate psychology, and rural 9271697.
Advisory Committee on health. • The webinar link is https://
Interdisciplinary, Community-Based The purpose of the ACICBL meeting hrsa.connectsolutions.com/acicbl.
Linkages; Notice of Meeting is to continue discussions on the Contact: Anyone requesting
ACICBL 16th report which is focused on information regarding the ACICBL
In accordance with section 10(a)(2) of should contact Dr. Joan Weiss, in one of
the Federal Advisory Committee Act enhancing community-based clinical
training. three ways: (1) Send a request to the
(Public Law 92–463), notice is hereby following address: Dr. Joan Weiss,
given of the following meeting: Agenda: The ACICBL agenda will be
Designated Federal Official, Bureau of
Name: Advisory Committee on available 2 days prior to the meeting on
Health Workforce, Health Resources and
Interdisciplinary, Community-Based the HRSA Web site at http://
Services Administration, Room 15N39,
Linkages (ACICBL) www.hrsa.gov/advisorycommittees/
mstockstill on DSK3G9T082PROD with NOTICES
5600 Fishers Lane, Rockville, Maryland
Dates and Times: September 19, 2016 bhpradvisory/acicbl/index.html.
20857; (2) call (301) 443–0430; or (3)
Place: Webinar/Conference Call SUPPLEMENTARY INFORMATION: Requests send an email to jweiss@hrsa.gov.
Status: The meeting will be open to to make oral comments or provide
the public. written comments to the ACICBL should Jason E. Bennett,
Purpose: The ACICBL provides advice be sent to Dr. Joan Weiss, Designated Director, Division of the Executive Secretariat.
and recommendations to the Secretary Federal Official, using the address and [FR Doc. 2016–19814 Filed 8–18–16; 8:45 am]
of the Department of Health and Human phone number below. Individuals who BILLING CODE 4165–15–P
VerDate Sep<11>2014 18:08 Aug 18, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 9990 E:\FR\FM\19AUN1.SGM 19AUN1](https://thefederalregister.org/doc/81_FR_55624/page/4.svg)
Document Created: 2016-08-19 01:35:20
Document Modified: 2016-08-19 01:35:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by September 19, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North,10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 55463 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR