11542 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN FOR HOSPITALS

Form name Number of 

hospitals 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Pre/Post-Interview Protocol ............................................................................. 6 156 $27.46 $4,284 

Quarterly Update Protocol ............................................................................... 6 36 27.46 989 

Usability Testing Protocol ................................................................................ 6 24 27.46 659 

AHRQ QI Data Collection Tool ........................................................................ 6 144 27.46 3,954 

Total .......................................................................................................... 24 360 NA 9,886 

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States, March 2009, ‘‘U.S. 

Department of Labor, Bureau of Labor Statistics.’’ Used as an overall average wage rate across the various types of staff involved in the quality 

improvements. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost of this project to 

the government. The estimated total cost 

for the evaluation work is $209,827 over 

the two-year year project, with an 

annualized total cost of $104,914. These 

costs were developed based on 

estimates of staff days required, to 

which administrative expenses are 

applied, and based on airfare, hotel, and 

per diem costs for staff travel for the site 

visits at the end of the evaluation. 

EXHIBIT 3—ESTIMATED COST OF THE EVALUATION

Cost component Total cost Annualized 

cost 

Protocol Development ............................................................................................................................................. $40,278 $20,139 

Data Collection Activities ......................................................................................................................................... 91,104 45,552 

Data Analysis ........................................................................................................................................................... 45,252 22,626 

Publication of Results .............................................................................................................................................. 24,370 12,185 

Travel for Site Visits ................................................................................................................................................ 8,823 4,412 

Total .................................................................................................................................................................. 209,827 104,914 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ healthcare research and 

healthcare information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: February 24, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–4948 Filed 3–10–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0121] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Mammography 

Quality Standards Act Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

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 and 

recordkeeping burden associated with 

the Mammography Quality Standards 

Act requirements. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 10, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11543 

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. 

The Mammography Quality Standards 

Act Requirements—21 CFR Part 900 

(OMB Control Number 0910–0309)— 

Extension 

The Mammography Quality Standards 

Act 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. This 

requires undergoing a review of their 

clinical images and providing the 

accreditation body 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 compliant mechanism. On the 

basis of this accreditation, facilities are 

then certified by FDA or an FDAapproved State certification agency and 

must prominently display their 

certificate. These actions are taken to 

ensure safe, accurate, and reliable 

mammography on a nationwide basis. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR 

Section 

No. 

of Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total 

Capital 

Costs 

Total Operating 

& Maintenance 

Costs 

900.3(b)(1) 0 .33 1 0 .33 1 0 .33 

900.3(b)(3) 

full1 0 .33 1 0 .33 320 106 10,000 

900.3(b)(3) 

limited2 5 1 5 30 150 

900.3(d)(2) 0 .1 1 0 .1 30 3 

900.3(d)(5) 0 .1 1 0 .1 30 3 

900.3(e) 0 .1 1 0 .1 1 0 .1 

900.3(f)(2) 0 .1 1 0 .1 200 20 $45 

900.4(c) 2,894 1 2,894 1 .5 4,341 

900.11(b)(1) 

900.11(b)(2) 

facility3

900.4(c) 

AB4 5 1 5 421 2,105 $173,620 

900.4(d) 2,894 1 2,894 .75 2,171 

900.11(b)(1) 

900.11(b)(2) 

facility3

900.4(d) 

AB4 5 1 5 211 1,055 

900.4(e) 8,681 1 8,681 1 8,681 $8,681 

900.11(b)(1) 

900.11(b)(2) 

facility3


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11544 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN—Continued 

21 CFR 

Section 

No. 

of Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total 

Capital 

Costs 

Total Operating 

& Maintenance 

Costs 

900.4(e) 

AB4 5 1 5 1,736 8,680 

900.4(f) 331 1 331 7 2,317 $77,640 

900.4(h) 

facility3 8,681 1 8,681 1 8,681 $3,820 

900.4(h) 

AB4 5 1 5 10 50 

900.4(i)(2) 1 1 1 16 16 

900.6(c)(1) 0 .1 1 0 .1 60 6 

900.11(b)(3) 5 1 5 .5 2 .5 

900.11(c) 400 1 400 5 2,000 

900.12(c)(2) 8,681 4,942 42,901,502 .0833333 3,575,124 $19,500,000 

900.12(c)(2) 

patient refusal5 87 1 87 .5 43 .5 

900.12(h)(4) 7 1 7 1 7 

900.12(j)(1) 

facility3 8 1 8 200 1,600 $120 

900.12(j)(1) 

AB4 8 1 8 320 2,560 $240 

900.12(j)(2) 2 1 2 100 200 $3,875 

900.15(c) 5 1 5 2 10 

900.15(d)(3)(ii) 1 1 1 2 2 

900.18(c) 2 1 2 2 4 

900.18(e) 2 1 2 1 2 

900.21(b) 0 .33 1 0 .33 320 106 $30,000 $174 

900.21(c)(2) 0 .1 1 0 .1 30 3 

900.22(h) 5 200 1,000 .083 83 20 

900.22(i) 2 1 2 30 60 

900.23 5 1 5 20 100 

900.24(a) 0 .4 1 0 .4 200 80 $42 

900.24(a)(2) 0 .15 1 0 .15 100 15 $21 

900.24(b) 1 1 1 30 30 

900.24(b)(1) 0 .3 1 0 .3 200 60 $42 

900.24(b)(3) 0 .15 1 0 .15 100 15 $21 

900.25(a) 0 .2 1 0 .2 16 3 .2 

FDA Form 3422 700 1 700 .25 175 

Total 3,620,673 $40,000 $19,768,361 

1One-time burden. 

2 Refers to accreditation bodies applying to accredit specific Full Field Digital Mammography units. 

3 Refers to the facility component of the burden for this requirement. 

4 Refers to the accreditation body 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. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11545 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual 

Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Total 

Capital 

Costs 

Total Operating 

& Maintenance 

Costs 

900.3(f)(1) 0 .1 1 0 .1 0 0 

900.4(g) 5 1 5 1 5 

900.12(a)(1)(i)(B)(2) 87 1 87 8 696 

900.12(a)(4) 8,681 4 34,724 1 34,724 

900.12(c)(4) 8,681 1 8,681 1 8,681 $28,000 

900.12(e)(13) 8,681 52 451,412 .083333 37,618 

900.12(f) 8,681 1 8,681 16 138,896 

900.12(h)(2) 8,681 2 17,362 1 17,362 

900.22(a) 5 1 5 1 5 

900.22(d) 5 1 5 1 5 

900.22(e) 5 1 5 1 5 

900.22(f) 3 1 3 1 3 

900.22(g) 5 1 5 1 5 $50 

900.25(b) 5 1 5 1 5 

Total 238,010 $28,000 $50 

The following sections of title 21 of 

the Code of Federal Regulations (CFR) 

were not included in the previously 

mentioned burden tables because they 

were 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 reporting or 

recordkeeping burden: 21 CFR 

900.12(c)(1) and (c)(3) and 21 CFR 

900.3(f)(1). 

Section 900.3(c) was not included in 

the previously mentioned burden tables 

because all four existing accreditation 

bodies are approved until late in 2013; 

so, no applicants will reapply during 

the requested information collection 

period. Section 900.24(c) was also not 

included in the previously mentioned 

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. 

Dated: March 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–5230 Filed 3–11–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0101] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Human Cells, 

Tissues, and Cellular and TissueBased Products: Establishment 

Registration and Listing; Form FDA 

3356; Eligibility Determination for 

Donors; and Current Good Tissue 

Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

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 information collection requirements 

for FDA regulations related to human 

cells, tissues, and cellular and tissuebased products (HCT/Ps) involving 

establishment registration and listing 

using Form FDA 3356; eligibility 

determination for donors; and current 

good tissue practice (CGTP). 

DATES: Submit written or electronic 

comments on the collection of 

information by May 10, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792. 

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) 


jlentini on DSKJ8SOYB1PROD with NOTICES