68364 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Notices 

TABLE 2—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN: CALORIE CONTENT 1—Continued 

Type of respondent Number of 

respondents 

Annual 

frequency per 

disclosure 

Total annual 

disclosures 

Hours per 

disclosure Total hours 

Other Chains ............................................................ 33,114 1 33,114 2 66,228 

Total Initial Hours ....................................................................................................................................................................... 964,348 

New SRFE Outlets ................................................... 600 2 1,200 2 2,400 

Vending (Ongoing) ................................................... 5,000 56,000 280,000,000 0 .05 14,000,000 

Vending (Growth) ..................................................... 5,000 140 700,000 0 .05 35,000 

Total Recurring Hours ................................................................................................................................................................ 14,037,400 

1There are no operating and maintenance costs associated with this collection of information. 

Burdens for Chain Vending Machine 

Operators 

Because almost all vending machines 

sell food that is previously 

manufactured and packaged, calorie 

analysis and production of calorie 

analysis displays will be most 

efficiently done at the manufacturer 

level instead of the operator level. 

Furthermore, most vended foods are 

subject to NLEA, which means that 

calorie content is already collected. A 

likely scenario for response to vending 

machine labeling is that food 

manufacturers include a set of calorie 

label stickers in each case of product. 

This would be efficient both because 

most manufacturers will already have 

the calorie information available, and 

because economies of scale exist for the 

manufacturer. In this case, vending 

machine operators will not need to keep 

a record of calorie content. Instead, the 

burden for most operators will be 

limited to that of administering records 

and passing the existing information on 

to consumers. 

FDA estimates that there are 

approximately 300,000 beverage 

machines that sell unpackaged 

products. The manufacturer of the 

ingredients to these foods (hot coffee 

drinks and sodas) would not necessarily 

have calorie information if the products 

were not subject to NLEA in some form. 

There are likely a limited number of 

manufacturers of the inputs to the 

beverage machines. For the purposes of 

this document, FDA estimates that there 

are 10 manufacturers serving these 

machines, and 20 drinks per 

manufacturer, so that approximately 200 

drinks would need to have calorie 

analysis. The cost of this calorie 

analysis will be included in the capital 

costs in the following paragraphs. FDA 

estimates that the recordkeeping burden 

for these firms is half that for 

restaurants, or two hours per item. If 

there are 600 firms using beverage 

dispensers, then the hourly burden for 

recordkeeping is 24,000 hours (= 600 

firms × 20 items/firm × 2 hours/item). 

FDA believes that the set of items sold 

in these dispensary machines is 

approximately constant. If there is .5 

percent growth in the number of firms, 

then approximately three new firms will 

become covered in this market in a 

given year. The burden associated with 

these three firms would be 120 hours (= 

3 firms × 20 items/firm × 2 hours/item). 

This amount is given in eighth row of 

table 1 of this document. 

The third party reporting for chain 

vending machine operators is the time 

necessary to install calorie displays on 

their vending machines. Because there 

is wide variation in the kinds of vending 

machines used—in materials, display, 

mechanism—there will likely be a 

variety of solutions. On the high end, a 

calorie display that is integrated with 

the graphics on the machine may cost 

several hundred dollars or more. On the 

low end, a set of calorie stickers affixed 

to the front of the machine would cost 

at most a few dollars per machine. 

Given the low margins in the vending 

machine industry, and given that nearly 

all of the regulated operators will be 

small businesses, FDA believes that 

almost all operators will, at least 

initially, choose the sticker option. In 

the long run, the manufacturers of 

vending machines, and the larger 

vending machine operators, such as the 

soft drink companies, may use the more 

integrated, and thus expensive, solution. 

FDA tentatively estimates a recurring 

hourly burden of 1 hour per machine, 2 

times per year to install the displays. If 

there are an average of 20 items per 

machine, then the burden per response 

is .05 hours (= 1 hours/machine/20 

items/machine).This will be the time 

necessary to decide where to put the 

displays on the machine, and to sort, 

remove and affix calorie stickers. FDA 

expects the stickers to have a relatively 

short life, and the mix of product in a 

machine to change over time. 

FDA estimates approximately 7 

million machines are serviced by 5,000 

operators, for an average number of 

machines per operator of 1,400 

machines. If each machine has 20 items, 

then the average number of responses 

per operator is 28,000. Given that 

stickers will likely need to be replaced 

twice per year on average, this number 

of responses doubles, to 56,000 

responses per operator. The total 

recurring hours needed for third party 

display is then 14 million hours (= 5000 

firms × 1,400 machines/firm x 20 

displays/machine × .05 hours/display × 

2). This amount is recurring in every 

year, and is given in row 7 of table 2 of 

this document. 

If growth in the vending machine 

industry is .5 percent, then each of the 

5,000 respondents will have an average 

of 7 additional machines that would 

need to report calorie content each year. 

With an average number of items per 

machine of 20, the number of 

disclosures per respondent is 140. At 

.05 hours per response, the hours 

needed to disclose calorie content on 

new machines is 35,000 hours per year 

(= 5000 firms × 7 machines/firm × 20 

items/machine × .05 hours/item). This 

amount is displayed in row 8 of table 2 

of this document. 

Dated: November 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28014 Filed 11–4–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0275] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Full-Field Digital Mammography 

System; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

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Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Notices 68365 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Full-Field Digital 

Mammography System.’’ This guidance 

document describes a means by which 

a full-field digital mammography 

(FFDM) system may comply with 

special controls that apply to these class 

II devices. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

final rule to reclassify these device types 

from class III into class II (special 

controls). 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Full-Field Digital 

Mammography System’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

Bldg. 66, rm. 4613, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your request, or fax your 

request to CDRH at 301–847–8149. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the guidance. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Mary Pastel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. G304, 

Silver Spring, MD 20993–0002, 301– 

796–6887; or 

Kyle J. Myers, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 62, rm. 3118, 

Silver Spring, MD 20993–0002, 301– 

796–2533. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 30, 

2008 (73 FR 31040), FDA issued a 

proposed rule to reclassify an FFDM 

system from class III (premarket 

approval) into class II (special controls). 

Also, in the Federal Register of May 30, 

2008 (73 FR 31128), FDA announced the 

availability of the draft guidance 

entitled ‘‘Class II Special Controls 

Guidance Document: Full-Field Digital 

Mammography System,’’ which would 

serve as a special control for the device. 

The comment period on the proposed 

rule closed on August 28, 2008. 

Following publication of the draft 

guidance, FDA received a number of 

comments. We are responding to 

comments concerning the guidance in 

this document. We are addressing 

comments concerning the classification 

regulation in the preamble to the final 

rule that is publishing elsewhere in this 

issue of the Federal Register. 

We reviewed the comments and took 

their suggestions into consideration in 

revising this guidance. The general 

changes we made to the guidance in 

response to the comments included: 

(1) Changing the risk of ‘‘incorrect 

patient positioning’’ to ‘‘inadequate 

breast coverage’’; (2) clarifying when 

different data are needed for integrated 

FFDM systems versus detector-only type 

FFDM systems; (3) revising the listed 

device description requirements for 

detector only systems; (4) revising the 

guidance to consistently use the term 

‘‘legally marketed (predicate) FFDM 

device’’; (5) revising the footnote 

referring to part 900 (21 CFR part 900), 

incorporating a tiered approach to 

reviewing FFDM devices; and (6) 

placing greater emphasis on laboratory 

testing. The changes we made to the 

clinical aspects of the guidance in 

response to the comments included: 

(1) Making the suggested measures less 

burdensome while providing reasonable 

assurance of safety and effectiveness 

and (2) removing, in some cases, 

suggested measures entirely when we 

believed that our concerns could be 

addressed by other measures that we 

had suggested. The changes we made to 

the technical aspects of the guidance in 

response to the comments included: 

(1) Removing the request for description 

and specifications of the display from 

the device description section; (2) 

removing the request for the life of the 

detector and the criteria for replacement 

and recognizing, in the section on 

‘‘Repeated Exposure Test,’’ international 

standards (International 

Electrotechnical Commission) IEC 

62220–1–2 and (Final Draft 

International Standard) FDIS IEC 

61223–3–2 in addition to the test 

recommended in Addendum on Digital 

Mammography: The European Protocol 

for the Quality Control of the Physical 

and Technical Aspects of 

Mammography Screening, version 1.0, 

November 2003; (3) removing the clause 

‘‘whether their [the detector defects] 

location overlaps the imaged breast’’ and 

graphical map recommendation and 

replacing it in the section now called 

‘‘Flat Field Correction and Pixel Defects’’ 

with the following components: ‘‘the 

number, spatial distribution (single 

pixels, lines, blocks), and types (dead 

pixel, sensitivity or offset out of 

acceptable range) of pixel defects 

allowed and the rationale for selecting 

these criteria; and the methods of 

compensation for these defects’’; (4) 

rewording the ‘‘Automatic Exposure 

Control Performance’’ section to ask for 

data based on tissue thickness only 

rather than preselected kilovolt peak, 

making it clear that the sponsor should 

only provide evaluation results for each 

available Automatic Exposure Control 

mode, and removing contrast testing; (5) 

replacing the request for ‘‘Bucky factor’’ 

with a request for grid ratio, primary 

transmission, selectivity, and contrast 

improvement factor; (6) revising section 

8 entitled ‘‘Physical Laboratory Testing, 

Breast Compression System’’ to follow 

the Mammography Quality Standards 

Act (MQSA) guidance for compression 

force, requesting the manufacturer to 

specify the minimum and maximum 

powered compressive force for their 

device and the reasons for choosing the 

limits, and removing references to 

accuracy and limits; (7) revising the 

‘‘Noise Analysis’’ and ‘‘Physical 

Measurements’’ portion of the guidance 

to reference International Standard IEC 

62220–1–2, section 6.3.2; (8) revising 

the ‘‘Signal-to-Noise Ratio Transfer— 

DQE’’ to reference International 

Standard IEC 62220–1–2; (9) revising 

the introduction to the ‘‘Physical 

Laboratory Testing’’ section to allow 

greater latitude in choice and be less 

prescriptive; (10) removing references to 

MQSA qualifications from the ‘‘Phantom 

Testing’’ section; and (11) revising the 

section addressing patient radiation 

dose to remove reference to the 

‘‘standard breast’’ and clarifying that 

FDA seeks phantom data only and 

reduce the range of breast sizes from 

2 to 8 centimeters (cm) to 2 to 6 cm. 

II. Significance of Special Controls 

Guidance 

FDA believes that adherence to the 

recommendations described in this 

guidance document, in addition to the 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of the FFDM system 

classified under § 892.1715 (21 CFR 

892.1715). In order to be classified as a 

class II device under § 892.1715, a new 

FFDM system must comply with the 

mstockstill on DSKH9S0YB1PROD with NOTICES

68366 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Notices 

requirements of special controls; 

manufacturers must address the issues 

requiring special controls as identified 

in the guidance document, either by 

following the recommendations in the 

guidance document or by some other 

means that provides equivalent 

assurances of safety and effectiveness. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Class II Special Controls 

Guidance Document: Full-Field Digital 

Mammography System,’’ you may either 

send an e-mail request to dsmica@fda.

hhs.gov to receive an electronic copy of 

the document or send a fax request to 

301–847–8149 to receive a hard copy. 

Please use the document number 1616 

to identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, subpart E, have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 814, subpart 

B, have been approved under OMB 

control number 0910–0231; the 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 900 have been approved under 

OMB control number 0910–0309. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: November 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28004 Filed 11–4–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, Pharmacokinetic 

Research in Pediatric HIV/TB Co-Infection. 

Date: December 2, 2010. 

Time: 9 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Anne Krey, Scientific 

Review Officer, Division of Scientific 

Review, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, NIH, 6100 Executive Blvd., 

Room 5B01 Bethesda, MD 20892. 301–435– 

6908. kreya@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: November 1, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28081 Filed 11–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development, 

Special Emphasis Panel, Williams Syndrome. 

Date: November 30, 2010. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Blvd., Rockville, MD 

(Teleconference). 

Contact Person: Norman Chang, PhD, 

Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Blvd., Room 5B01, Bethesda, MD 20892, 

301–496–1485, changn@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: November 1, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28079 Filed 11–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

mstockstill on DSKH9S0YB1PROD with NOTICES