8/ 31/ 05 Excerpts from RACT section of Response to Comment Document b. Addressing NO x SIP Call and RACT Docket No.: OAR 2003 0079 0122, 0187, 0199, 0215, 0218, 0224, 0229, 0232, 0243, 0269, 0270, 0081, 0281, 0282, 0283, 0292, 0308, 0314, 0315, 0321, 0442, 0443, 0465, 0469, 0470, 0506, and 0543 Comment: Comments: Several State and industry commenters supported EPA's proposed approach. These commenters stated that the level of emissions reductions required by the NO x SIP call is far greater than the level of reductions achieved by controls that have been determined to be NO x RACT. One State encourages EPA to provide this exemption to other areas subject to approved cap and trade programs in addition to those areas affected by the NO x SIP call. The EPA also received comments, primarily from several States and environmental groups, opposing the approach. These commenters stated that there are no exceptions to the RACT mandates in either subpart 1 or subpart 2 for sources subject to SIP call cap and trade programs, and EPA is without authority to invent such an exception. Because the NO x SIP Call's cap and trade program does not require emission control technologies to be installed at a particular source, some commenters conclude that RACT requirements are necessary and appropriate to ensure that all sources implement at least a minimum level of control. One State indicated there have been numerous cases where sources subject to the NO x SIP Call have not had to install controls comparable to RACT. Commenters also suggested that RACT is intended to be a benchmark for control technology at individual stationary sources, not a level of regional reductions. In addition, some commenters noted that the NO x SIP Call requirements are specific to the ozone season, where RACT requirements are year round. Consequently, these commenters recommended that EPA should also consider non ozone related nitrogen issues, including fine particles, visibility, nitrification and acidification of watersheds and eutrophication of coastal waters all of which would be reduced with year round controls.

Response: The preamble to the final phase 2 rule provides the response to these comments. In addition, the footnote referring to Integrated Planning Model ( IPM) runs of the CAIR rulemaking which project EGUs that are expected to have NO x controls in 2010 refers to an analysis in the response to comment. That analysis follows:

To help determine if sources meeting the NO x SIP Call requirements and subject to NO x RACT requirements for the 8 hour ozone standard will be operating RACT level combustion controls by 2010, EPA analyzed data from IPM runs for the Clean Air Interstate final rule ( CAIR). The data, " IPM Base Case 2010 Parsed," are available in the CAIR docket ( at http:// www. epa. gov/ airmarkets/ epa ipm/ iaqr. html) and show which electricity generating units ( EGUs) currently have controls, and which additional units are projected to have NO x controls in 2010. Many units already have NO x controls in place. As described below, the results of the analysis support the conclusion that the vast majority of sources meeting the NO x SIP Call requirements and subject to NO x RACT requirements for the 8 hour ozone standard will utilize RACT level combustion controls or more stringent controls to meet existing requirements. 1To reach this count, EPA supplemented information in the 2010 IPM base case spreadsheet with additional information placed in the docket ( electronic mail message of August 30, 2005, re: " email for phase II ozone rule docket ( with correction)). Further analysis supports the conclusion that most EGU sources outside the NO x SIP call region that are located in states subject to CAIR, and are located in areas subject to NO x RACT for the 8 hour ozone standard, will utilize RACT level combustion controls or more stringent controls to meet existing state rules and, assuming states implement CAIR through EGU controls, 2009 CAIR NO x requirements. SIP call states: The data base included 8,517 EGUs in the CAIR 2010 emission inventory. Our analysis considered the 681 EGUs in the data base for the NO x SIP call states which are projected to emit more than 1 ton per day of NO x in 2010. This level of emissions approximates the cutoff level for " large" EGUs in the NO x SIP Call Rule. Of the 681 EGUs, only 3 6 are projected to be without NO x controls in 2010 CAIR base case and subject to an 8 hour ozone NO x RACT determination. The units identified as uncontrolled in the 2010 base case are located in the Chicago and Cleveland areas. In the Chicago area, although up to three units may be uncontrolled ( two of these have not been operated for the past year and a half), a majority of the units in the area already have combustion controls in place. 1 Also, it should be noted that the Chicago area was granted a waiver from NO x RACT under the 1 hour ozone standard based on a dispersion modeling analysis; it is unclear whether such a waiver would be requested and granted under the 8 hour standard. In that event, NO x RACT determinations would not be required. In Cleveland, although three EGUs were identified as uncontrolled, there are 7 additional large EGUs in the same area, all of which are expected to have NO x controls ( low NO x burners, selective noncatalytic reduction ( SNCR) and/ or selective catalytic reduction ( SCR). Therefore, both the Chicago and Cleveland areas may meet RACT by averaging. Further NO x controls may result from CAIR and/ or 8 hour ozone and PM2.5 attainment demonstration requirements ( the highest particulate nitrate concentrations in the East tend to occur in cooler regions, 70 FR 25129) because installation of combustion controls to decrease NO x emissions is almost always the most cost effective NO x reduction strategy. As a result, EPA expects that sources subject to the CAIR or NO x SIP Call cap and trade programs in these areas will employ at least RACT level controls. CAIR States Outside the NO x SIP Call Region: In a similar manner, the same 2010 CAIR base case data was used to determine if EGUs in 8 hour ozone nonattainment areas that emit more than one ton/ day of NO x will be operating RACT level combustion controls by 2010 in the following scenario: ( 1) subject to CAIR for ozone, ( 2) not subject to the NO x SIP Call requirements and ( 3) subject to NO x RACT requirements for the 8 hour ozone standard. The following 6 States are subject to CAIR for ozone but are not included in the NO x SIP Call: Arkansas, Florida, Iowa, Louisiana , Mississippi and Wisconsin. The following States do not contain areas subject to NO x RACT for the 8 hour ozone standard: Florida, Iowa, Louisiana ( Baton Rouge is marginal), and Mississippi. Crittenden County in Arkansas is subject to NO x RACT for the 8 hour ozone standard; however, there are no large EGUs in the data base for this area. The Milwaukee and Sheboygan areas in Wisconsin are subject to NO x RACT for the 8 hour ozone standard; in these areas 11 of 13 large EGUs have combustion controls for NO x in the 2010 base case. The two without NO x controls are both located in Milwaukee County ( South Oak Creek). Thus, there may be only two EGUs at one site which are subject to CAIR and NO x 2 There are not currently any 8 hour areas in Georgia that have new RACT requirements under the 8 hour ozone standard. Atlanta is classified as marginal for the 8 hour standard, but was subject to RACT under the 1 hour standard for its former 1 hour classificaiton. Although the Atlanta 8 hour nonattainment area includes areas not in the former 1 hour nonattainment area, none of the new areas are subject to the marginal area requirement for RACT corrections under section 182( a)( 2). Chattanooga is an early action area with deferred nonattainment status, so the RACT requirement is not currently applicable. However, EGUs in the Atlanta area are subject to existing state NO x rules that have resulted in controls ( combustion controls and in several cases, SCR) on most units. There are 2 other 8 hr nonattainment areas in GA, both covered under subpart 1 and expected to attain by 2009 ( no extension beyond 5 years), so under our subpart 1 RACT rule, they would only need to demonstrate that they attain as expeditiously as practicable: ( 1) Macon and ( 2) Murray County ( Chattahoochee Nat. Forest).

3 The Houston and Dallas areas are subject to 8 hour ozone NO x RACT. San Antonio is a early action area with deferred nonattainment ( subpart 1) status, and Beaumont is a marginal 8 hour ozone area, so 8 hour ozone RACT is not currently applicable in those areas ( though Beaumont was subject to the RACT requirement under the 1 hour standard). EGUs in all of these areas are subject to EGU NO x rules that apply across a broad area of East Texas and are close to the NO x SIP call in stringency. More stringent NO x limits apply to EGUs in Beaumont, Dallas and Houston. RACT for ozone, are outside the NO x SIP Call area, and are expected to be uncontrolled for NO x in the 2010 CAIR base case. Because there are six additional EGUs in Milwaukee County, all of which are expected to have NO x controls ( two with close coupled low NO x burners with overfire air using subbituminous coal), in the 2010 base case, it is likely that the area may be able to demonstrate RACT by averaging emissions over all the affected sources. Further, because installation of combustion controls to decrease NO x emissions is almost always the most costeffective strategy and since the 2010 CAIR base case did not take into consideration that the area is subject to attainment demonstration requirements for both ozone and PM2.5 ( the highest particulate nitrate concentrations in the East tend to occur in cooler regions), EPA expects sources subject to the CAIR cap and trade program in Milwaukee will employ at least RACT level controls. The following states are in the CAIR PM region but not the CAIR ozone region: Texas, Georgia, and Minnesota. Minnesota has no ozone nonattainment areas. Georgia and Texas do have 8 hour nonattainment areas. An annual NO x cap applies in the CAIR PM region that is similar in stringency to the seasonal NO x cap for the ozone CAIR states. Due to the CAIR annual NO x requirements and the fact that combustion controls are almost always the most cost effective NO x reduction strategy, previous RACT requirements under the 1 hour standard, other NO x limitations applicable to EGUs under Georgia2 and Texas3 rules to promote attainment of the 1 hour standard, and 8 hour attainment demonstration requirements, we expect that the majority of EGUs in 8 hour nonattainment areas in those states will employ at least RACT level controls.

Comments: Some commenters pointed out that many companies have employed averaging programs for NO x SIP Call compliance and want this option preserved under the 8 hour ozone standard since requiring sources to individually meet NO x RACT requirements would greatly increase the costs of compliance at sources already subject to the NO x cap and trade program without achieving greater emission reductions.

Response: In some cases, a facility or a group of sources in a nonattainment area might choose to meet NO x RACT by adopting an emissions averaging concept within the area; e. g., over controlling one or more large units and not controlling other smaller units. We agree with comments that emission averaging and cap and trade programs such as the NO x SIP Call Rule achieve emission reductions at lower costs. The EPA's NO x RACT guidance, published on November 25, 1992 ( 57 FR 55625), was, in part, for the purpose of " enhancing the ability of States to adopt market based trading systems for NO x" and to encourage States to " structure their RACT requirements to inherently incorporate an emissions averaging concept ( i. e., installing more stringent controls on some units in exchange for lesser control on others)." Since the NO x SIP Call requires greater reductions, on average, than RACT, ( see proposal notice at 68 FR 32839 and discussion below) we believe the average emissions across the facilities ( in this example) would be less than emissions under application of a RACT program alone. We would also expect this scenario to be a short term case since facilities may choose later to install controls on the smaller units and sell any excess allowances, depending on the projected cost of allowances.

Docket No.: OAR 2003 0079 0232, 0283 Comment: In cases where States have adopted controls consistent with the NO x SIP Call for cement kilns ( i. e., 30 percent reduction), the State need not submit a new NO x RACT SIP for those sources. Response: As described in the final rulemaking notice, EPA agrees with this comment. In addition, EPA believes the concept should also apply to stationary internal combustion engines for the same reasons, given that the NO x SIP Call Phase 2 rulemaking is completed.

* * * * *

d. Addressing RACT Guidance Docket No.: OAR 2003 0079 0081, 0122, 0149, 0218, 0230, 0232, 0243, 0259, 0260, 0262, 0281, 0282, 0283, 0308, 0315, 0321, 0334, 0335, 0440, 0442, 0443, 0469, and 0470 Comments: The EPA received several comments for and against the proposal that States may use a prior RACT determination with respect to the 1 hour ozone standard for purposes of meeting the RACT requirements for the 8 hour ozone standard. Further, EPA received comments for and against the proposal that a new RACT determination is required in cases where the initial RACT analysis under the 1 hour standard for a specific source or source category concluded that no additional controls were necessary. Several State and industry commenters supported EPA's proposed approach that a prior RACT analysis under the 1 hour ozone standard should meet RACT requirements under the 8 5 hour standard where major sources or source categories were previously reviewed and controls applied to meet RACT. These commenters stated that RACT is not specific to any particular ozone standard, such that once a source has met RACT, it has met RACT, whether or not the ozone standard is revised to become more ( or less) stringent; just as with the 15 percent VOC requirement, the statute provides no basis for duplicative imposition of RACT; and there is no basis in the statute to read in a new requirement for RACT. In addition, some industry commenters stated that electric generating units which meet Title IV NO x control requirements would also meet the NO x RACT requirement. The EPA also received comments from several States opposing EPA's proposed approach. These commenters believe the NO x and VOC guidance is too old, needs updating and, in the case of NO x controls, the improvement over the last three years has been dramatic with controls previously considered to be Best Available Control Technology ( BACT) ( and therefore generally considered at the time to be more stringent than RACT) are now considered to be merely RACT. In addition, one State suggested the presumptive RACT level should be revised to at least 85 percent control or that NO x RACT should be defined as up to $ 10,000/ ton of pollutant removed. Two States disagreed with EPA's proposal that a new RACT determination should be required in cases where the initial RACT analysis under the l hour NAAQS found that no additional controls were necessary for a specific source or source category. They indicated such re analysis would be an unwise use of resources because it would not yield significant benefits. Further, they do not agree that a RACT determination is warranted for major VOC or NO x sources not in existence during the previous RACT determination, because new sources in 1 hour nonattainment areas have been permitted pursuant to the requirements for NSR and, where applicable, have already been subject to more stringent control requirements. Response: The EPA response is addressed in the preamble to the final rulemaking notice, section IV. G. 1. c. " What requirements should apply for RACM and RACT for 8 hour ozone nonattainment areas?" Although we drafted regulatory language for this aspect of the RACT program ( and for other RACT provisions), we believe it is sufficient to describe EPA's views on the details of the RACT program in today's preamble and in other guidance ( e. g., the NO x Supplement to the General Preamble, 11 25 92); thus, some detailed portions of the proposed regulatory text regarding RACT were not retained in the final rule.

In the preamble, we noted B $ For VOC sources subject to MACT standards, States may streamline their RACT analysis by including a discussion of the MACT controls and relevant factors such as whether VOCs are well controlled under the relevant MACT air toxics standard, which units at the facility have MACT controls, and whether any major new developments in technologies or costs have occurred subsequent to the MACT standards..

$ We believe that there are many VOC sources that are well controlled ( e. g., through addon controls or through substitution of non VOC non HAP materials for VOC HAP materials) because they are regulated by the MACT standards, which EPA developed under CAA section 112. 4However, there are some MACT categories for which it may not be possible to determine the degree of VOC reductions from the MACT standard without additional analysis; for example, the miscellaneous metal parts and products ( 40 CFR part 60, subpart MMMM) due to the uncertainty of the compliance method that will be selected.

6 $ Any source subject to MACT standards must meet a level that is as stringent as the bestcontrolled 12 percent of sources in the industry. Examples of these HAP sources that may effectively control VOC emissions include organic chemical plants subject to the hazardous organic NESHAP ( HON), pharmaceutical production facilities, and petroleum refineries. 4 $ We believe that, in many cases, it will be unlikely that States will identify emission controls more stringent than the MACT standards that are note prohibitively expensive and are thus unreasonable. We believe this will allow States, in many cases, to rely on the MACT standards for purposes of showing that a source has met VOC RACT.

Some commenters stated that the BACT or LAER provisions would assure at least RACT level controls on such sources. We noted in the preamble B $ That we agree this should be true in many cases, but not all.

$ The BACT/ LAER analyses do not automatically ensure compliance with RACT since the regulated pollutant or source applicability may differ and the analyses may be conducted many years apart.

$ States may, however, rely on information gathered from prior BACT or LAER analyses for the purposes of showing that a source has met RACT to the extent the information remains valid. In general, except where we have indicated in the preamble that a MACT standard would satisfy the RACT requirement, States are expected to analyze whether compliance with a BART, BACT, LAER, or MACT standard or determination would constitute RACT. Factors to consider in such an analysis include:

! Whether the prior determination focused on other pollutants and program purposes and therefore may not have required any control of VOC or NOx.

! Whether the prior determination my have focused on other pollutants and program purposes, and may have resulted in some limited reduction in an ozone precursor that does not represent RACT equivalent control ( e. g., a MACT standard that allows substitution of non HAP VOCs for HAP VOCs may not result in significant VOC reduction).

! Whether the prior determination may have involved review of some, but not all, of the emission points subject to RACT.

! Whether applicability thresholds for the prior determination were higher than the applicability threshold for RACT that exists in the nonattainment area. 7 ! Whether costs of an existing control technology may have dropped since the prior determination.

! Whether control efficiency of an existing control technology may have significantly increased since the prior determination.

! Whether new control technologies have become available since the prior determination.


[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39731-39734]
[FR Doc No: 2013-15790]

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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 August
1, 2013.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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--(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 (c)(3) and 21 CFR 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.)
    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 February 28, 2013 (78 FR 13681), 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       Number of     Total annual       Average       Total      Total      operating &
       Activity/21 CFR section/form FDA No.           respondents    responses per     responses      burden per    hours \1\   capital     maintenance
                                                                      respondent                       response                  costs         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of intent to become an AB--                      0.33               1            0.33               1          1  .........  ..............
 900.3(b)(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--                       0.1               1             0.1              30          3  .........  ..............
 900.3(d)(5)......................................
Letter of intent to relinquish accreditation                   0.1               1             0.1               1          1  .........  ..............
 authority--900.3(e)..............................
Summary report describing all facility                         330               1             330               7      2,310  .........         $77,600
 assessments--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--                     5             200            1000           0.083         83     30,000  ..............
 900.22(h)........................................
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       Number of     Total annual   Average burden    Total      Total      operating &
              Activity/21 CFR section                recordkeepers    records per       records           per       hours \1\   capital     maintenance
                                                                     recordkeeper                    recordkeeping               costs         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 physician initial                 87               1              87               8        696  .........  ..............
 requirements--900.12(a)(1)(i)(B)(2)..............
Documentation of interpreting physician personnel            8,654               4          34,616               1     34,616  .........  ..............
 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--900.12(e)(13)..           8,654              52         450,008           0.083     37,351  .........  ..............
Audit program--900.12(f)..........................           8,654               1           8,654              16    138,464  .........  ..............
Consumer complaints system; facility--900.12(h)(2)           8,654               2          17,308               1     17,308  .........  ..............
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 review--                    5               1               5               1          5  .........  ..............
 900.22(f)........................................
Processes for patient notifications--900.22(g)....               3               1               3               1          3  .........             $30
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 Disclosures \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                                  Number of       Number of     Total annual   Average burden    Total      operating &
                   Activity/21 CFR section                       respondents     disclosures     disclosures   per disclosure  hours \2\    maintenance
                                                                               per respondent                                                  costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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  ..............
 900.11(b)(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  ..............
 900.11(b)(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 900.11(b)(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)...................................
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\--900.12(c)(2)              87               1              87             0.5         44  ..............
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: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15790 Filed 7-1-13; 8:45 am]
BILLING CODE 4160-01-P