17132 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 

information as well as the adoption of 

electronic recordkeeping and electronic 

submission of data to the agency; and, 

review of product tracing procedures 

should be part of standard audits. 

(Response) FDA agrees that 

recordkeeping is key to effective 

product tracing. However, to the extent 

that the comments suggest changes to 

the requirements of the recordkeeping 

regulations in sections 1.326 through 

1.363, such requests are outside the 

scope of the four collection of 

information topics on which the notice 

solicits comments. Such changes to the 

current recordkeeping requirements can 

only be accomplished by notice and 

comment rulemaking. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Annual frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

1.337, 1.345, and 1.352 (Records maintenance) ................ 379,493 1 379,493 13.228 5,020,000 

1.337, 1.345, and 1.352 (Learning for new firms) ............... 18,975 1 18,975 4.790 90,890 

Total .............................................................................. ........................ ........................ ........................ ........................ 5,110,890 

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

This estimate is based on FDA’s 

estimate of the number of facilities 

affected by the final rule entitled 

‘‘Establishment and Maintenance of 

Records Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002,’’ published in 

the Federal Register of December 9, 

2004 (69 FR 71562 at 71630). With 

regard to records maintenance, FDA 

estimates that approximately 379,493 

facilities will spend 13.228 hours 

collecting, recording, and checking for 

accuracy of the limited amount of 

additional information required by the 

regulations, for a total of 5,020,000 

hours annually. In addition, FDA 

estimates that new firms entering the 

affected businesses will incur a burden 

from learning the regulatory 

requirements and understanding the 

records required for compliance. In this 

regard, the Agency estimates the 

number of new firms entering the 

affected businesses to be 5 percent of 

379,493, or 18,975 firms. Thus, FDA 

estimates that approximately 18,975 

facilities will spend 4.790 hours 

learning about the recordkeeping and 

records access requirements, for a total 

of 90,890 hours annually. Therefore, the 

total annual recordkeeping burden is 

estimated to be 5,110,890 hours. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7188 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0017] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary National 

Retail Food Regulatory Program 

Standards 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by April 27, 

2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0621. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Voluntary National Retail Food 

Regulatory Program Standards—(OMB 

Control Number 0910–0621)—Extension 

The Program Standards define nine 

essential elements of an effective 

regulatory program for retail food 

establishments, establish basic quality 

control criteria for each element, and 

provide a means of recognition for those 

state, local, and tribal regulatory 

programs that meet the Program 

Standards. The program elements 

addressed by the Program Standards are 

as follows: (1) Regulatory foundation, 

(2) trained regulatory staff, (3) 

inspection program based on Hazard 

Analysis and Critical Control Point 

(HACCP) principles, (4) uniform 

inspection program, (5) foodborne 

illness and food defense preparedness 

and response, (6) compliance and 

enforcement, (7) industry and 

community relations, (8) program 

support and resources, and (9) program 

assessment. Each standard includes a 

list of records needed to document 

compliance with the standard (referred 

to in the Program Standards document 

as ‘‘quality records’’) and has one or 

more corresponding appendices that 

contain forms and worksheets to 

facilitate the collection of information 

needed to assess the retail food 

regulatory program against that 

standard. The respondents are State, 

local and tribal government Agencies. 

Regulatory Agencies may use existing, 

available records or may choose to 

develop and use alternate forms and 

worksheets that capture the same 

information. 

In the course of their normal 

activities, state, local, and tribal 


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Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 17133 

regulatory Agencies already collect and 

keep on file many of the records needed 

as quality records to document 

compliance with each of the Program 

Standards. Although the detail and 

format in which this information is 

collected and recorded may vary by 

jurisdiction, records that are kept as a 

usual and customary part of normal 

Agency activities include inspection 

records, written quality assurance 

procedures and records of quality 

assurance checks, staff training 

certificates and other training records, a 

log or database of food-related illness or 

injury complaints, records of 

investigations resulting from such 

complaints, an inventory of inspection 

equipment, records of outside audits, 

and records of outreach efforts (e.g., 

meeting agendas and minutes, 

documentation of food safety education 

activities). No new recordkeeping 

burden is associated with these existing 

records, which are already a part of 

usual and customary program 

recordkeeping activities by state, local, 

and tribal regulatory Agencies, and 

which can serve as quality records 

under the Program Standards. 

State, local, and tribal regulatory 

Agencies that enroll in the Program 

Standards and seek listing in the FDA 

National Registry are required to report 

to FDA on the completion of the 

following three management tasks 

outlined in the Program Standards: (1) 

Conducting a program self assessment, 

(2) conducting a baseline survey of the 

regulated industry, and (3) obtaining an 

independent outside audit (verification 

audit). The results are reported to FDA 

on Form FDA 3519, ‘‘FDA National 

Registry Report’’ and Form FDA 3520, 

‘‘Permission to Publish in National 

Registry.’’ These forms are located in 

Appendix I of the Program Standards 

document. If a regulatory Agency 

follows all the recordkeeping 

recommendations in the individual 

standards and their appendices, it will 

have all the information needed to 

complete the forms. 

In April 2010, the Conference for 

Food Protection approved changes to 

the Program Standards. The changes 

have been incorporated into a draft 2011 

revision, which will be available at: 

http://www.fda.gov/ 

retailfoodprotection. One change was to 

provide an extension of time for 

completion of the three management 

tasks. Another change was the inclusion 

of clarifying language in Standard 9 that 

a jurisdiction may use its inspection 

data to conduct its study of risk factor 

occurrence. Although this was always 

the intent in Standard 9, it was not clear 

to jurisdictions that this was a viable 

option. 

FDA analyzed whether incorporation 

of these changes alters its estimate of the 

recordkeeping and reporting burdens. 

FDA concluded that the changes will 

lessen the annual recordkeeping burden 

estimate because the management tasks 

will be conducted on a less frequent 

basis annually. Thus, based on its 

experience with the Program Standards 

over the past 3 years, FDA has reduced 

its estimate of the hours per record to 

94.29, from the previously estimated 

157 hours per record in 2008. The 

reduced recordkeeping burden hour 

estimates are shown in table 1 of this 

document. FDA notes that jurisdictions 

that choose to analyze their inspection 

data per the Standard 9 criteria will 

enjoy a less resource intensive method 

for tracking risk factor trends over time. 

However, the Agency has not reduced 

its estimate of 333 hours for Standard 9 

shown in table 2 of this document. The 

Agency will consider reducing this 

estimate in a future information 

collection request based on supporting 

data it expects to receive in the future 

from participating jurisdictions. The 

two noted changes had no effect on the 

reporting burden hour estimates shown 

in table 2 of this document. 

Recordkeeping 

FDA’s recordkeeping burden estimate 

includes time required for a State, local, 

or tribal Agency to review the 

instructions in the Program Standards, 

compile information from existing 

sources, and create any records 

recommended in the Program Standards 

that are not already kept in the normal 

course of the Agency’s usual and 

customary activities. Worksheets 

(Appendices) are provided to assist in 

this compilation. In estimating the time 

needed for the program self-assessment 

(Program Standards 1–8, shown in table 

1 of this document), FDA considered 

responses from four state and three local 

jurisdictions that participated in an FDA 

Program Standards Pilot study. Table 2 

of this document shows the estimated 

recordkeeping burden for the 

completion of the baseline data 

collection and table 3 of this document 

shows the estimated recordkeeping 

burden for the verification audit. 

In the Federal Register of January 12, 

2011 (76 FR 2124), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. FDA received six comment 

letters in response to the notice. One 

comment was generally supportive of 

the necessity of the information 

collection and its practical utility. Five 

letters contained comments outside the 

scope of the four collections of 

information topics on which the notice 

solicits comments and thus, will not be 

addressed here. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1—SELF ASSESSMENT

Standard Recordkeeping activity Hours per record 

No. 1. Regulatory Foundation Self Assessment: (Appendix A) Completion of worksheet recording results of evaluations 

and comparison on worksheets 1.

16 

No. 2. Trained Regulatory 

Staff.

Self Assessment: (Appendix B–2 and B–4)1 Completion of the Center for Food Protection 

Field Training Manual and Documentation of Successful Completion—Field Training 

Process; completion of summary worksheet of each employee training records 2.

19 .3 

No. 3. Hazard Analysis and 

Critical Control Point.

Self Assessment: (Appendix C 1) Completion of worksheet documentation .......................... 4 

No. 4. Uniform Inspection 

Program.

Self Assessment: (Appendix D 1) Completion of worksheet documentation of jurisdiction’s 

quality assurance procedures 2.

19 

No. 5. Foodborne Illness Investigation.Self Assessment: (Appendix E1) Completion of worksheet documentation .......................... 5 

No. 6. Compliance Enforcement.Self Assessment: (Appendix F 1) Selection and review of 20 to 70 establishment files @ 

25 minutes per file. Estimate is based on a mean number of 45. Completion of worksheet.

19 

No. 7. Industry & Community 

Relations.

Self Assessment: (Appendix G 1) Completion of worksheet .................................................. 2 


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17134 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 

TABLE 1—SELF ASSESSMENT—Continued 

Standard Recordkeeping activity Hours per record 

No. 8. Program Support and 

Resources.

Self Assessment: (Appendix H 1) Selection and review of establishment files ...................... 8 

Subtotal ........................... ................................................................................................................................................. 92 .3 

1Or comparable documentation. 

2Estimates will vary depending on number of regulated food establishments and the number of inspectors employed by the jurisdiction. 

TABLE 2—BASELINE DATA COLLECTION

Standard Recordkeeping activity Hours per record 

No. 9. Program Assessment .. Baseline Data Collection (Appendices I & J) Selection and inspection of randomly selected statistical sample of 9 to 87 establishments from each of 9 facility types 1.333 

1 Calculation based on mean sample size of 39 and average FDA inspection time for each establishment type. Estimates will vary depending 

on number of regulated food establishments within a jurisdiction and the number of inspectors employed by the jurisdiction. 

TABLE 3—VERIFICATION AUDIT

Standard Recordkeeping activity Hours per record 

No. 9 ...................................... Verification Audit (Appendices I & J) 1 .................................................................................... 46.15 

1We estimate that no more than 50% of time spent to complete self assessment of all 9 Standards is spent completing verification audit worksheets. Time will be considerably less if less than 9 standards require verification audits. 

Thus, FDA estimates the 

recordkeeping burden for this collection 

of information as follows: 

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

FDA Worksheets 2 Number of recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping 

(in hours) 

Total hours 

Appendices A–J ..................................... 500 1 500 94.29 47,145 

Total ................................................ .............................. .............................. .............................. .............................. 47,145 

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

2Or comparable documentation. 

FDA bases its estimates of the number 

of recordkeepers and the hours per 

record on its experience with the 

Program Standards over the past 3 years. 

FDA estimates that approximately 500 

regulatory jurisdictions will participate 

in the Program Standards. There are 

approximately 3,000 jurisdictions in the 

United States and its territories that 

have retail food regulatory programs. 

Enrollment in the Program Standards is 

voluntary and, therefore, FDA does not 

expect all jurisdictions to participate. 

FDA bases its estimate of the hours 

per record on the recordkeeping 

estimates for the management tasks of 

self assessment, baseline data collection, 

and verification audit (tables 1, 2, and 

3 of this document) that enrolled 

jurisdictions must perform, a total of 

471.45 hours (92.3 + 333 + 46.15 = 

471.45). As noted, based on its 

experience with the Program Standards 

over the past 3 years, FDA has reduced 

its estimate of the number of 

recordkeeping hours that enrolled 

jurisdictions will perform annually to 

94.29, from the previously estimated 

157 hours per record in 2008. FDA 

estimates that, annually, 500 

recordkeepers will spend 94.29 hours 

performing the required recordkeeping 

for a total of 47,145 hours. 

Reporting 

FDA requires regulatory jurisdictions 

that participate in the Program 

Standards to submit two forms 

annually: Form FDA 3519, ‘‘FDA 

National Registry Report,’’ and Form 

FDA 3520, ‘‘Permission to Publish in 

National Registry.’’ Form FDA 3519 

requires the name and address of the 

jurisdiction; completion dates for the 

self assessment, baseline survey 

(original and update), and verification 

audit; names of the person(s) who 

completed the self-assessment, 

verification audit, baseline survey, 

baseline survey update, and action plan; 

signature of the program manager; and 

date the form was completed. Form FDA 

3520 requires the name of the 

jurisdiction, completion date of the self 

assessment, date of the verification 

audit report, name of the auditor, 

signature and title of the official 

completing the form, and date the form 

was completed. 

The reporting burden in table 5 of this 

document includes only the time 

necessary to fill out and send the forms, 

as compiling the underlying information 

(including self-assessment reports, 

baseline surveys, outside audits, and 

supporting documentation) is accounted 

for under the recordkeeping estimates in 

table 1 of this document. 

FDA estimates the reporting burden 

for this collection of information as 

follows: 


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Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 17135 

1All guidance titles throughout this document 

reflect the style of the published versions. 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1

Form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

respondents 

Average burden 

per response 

(in Hours) 2

Total hours 

3519 ....................................................... 500 1 500 1/60 50 

3520 ....................................................... 500 1 500 1/60 50 

CFP Training Plan and Log ................... 500 3 1,500 1/60 150 

Total ................................................ .............................. .............................. .............................. .............................. 250 

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

2Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. 

FDA bases its estimates of the number 

of respondents and the hours per 

response on its experience with the 

Program Standards over the past 3 years. 

As explained previously in this 

document, FDA estimates that 500 

regulatory jurisdictions will enroll in 

the Program Standards. FDA estimates a 

total of 12 minutes annually for each 

enrolled jurisdiction to complete both 

forms. FDA bases its estimate on the 

small number of data elements on the 

two forms and the ease of availability of 

the information. FDA estimates that, 

annually, 500 regulatory jurisdictions 

will submit one Form FDA 3519 for a 

total of 500 annual responses. Each 

submission is estimated to take 0.1 hour 

per response for a total of 50 hours. FDA 

estimates that, annually, 500 regulatory 

jurisdictions will submit one Form FDA 

3520 for a total of 500 annual responses. 

Each of these submissions is estimated 

to take 0.1 hour per response for a total 

of 50 hours. FDA estimates that, 

annually, 500 regulatory jurisdictions 

will submit three requests for 

documentation of successful completion 

of staff training using the CFP Training 

Plan and Log for a total of 1,500 annual 

responses. Each submission is estimated 

to take 0.1 hour per response for a total 

of 150 hours. Thus, the total reporting 

burden for this information collection is 

250 hours. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7191 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0148] 

Clarifying Edits to Existing Special 

Controls Guidance Documents; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of updated special controls 

guidance documents for class II devices, 

which contain edits that reflect the 

Agency’s effort to clarify questions and 

confusion regarding its position on the 

binding nature of special controls 

guidance documents. The revised 

language does not change the Agency’s 

position or view, but rather is intended 

to clarify its position and remedy any 

possible confusion or 

misunderstanding. 

DATES: Submit either electronic or 

written comments on this document at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: See the SUPPLEMENTARY

INFORMATION section for electronic 

access to affected documents. 

Submit electronic comments on this 

document 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: 

Philip Desjardins, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5452, Silver Spring, 

MD 20993–0002, 301–796–5678; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In December 2008, FDA revised the 

cover sheet and standard language in 

newly issued special controls guidance 

documents to clarify the effect of a 

guidance that has been established as a 

special control (‘‘special controls 

guidance’’). In order to comply with the 

special controls guidance, 

manufacturers must address each 

identified risk to health presented in the 

guidance for the class II device by either 

meeting the recommendations of the 

guidance or by some other means that 

provides equivalent assurances of safety 

and effectiveness. 

FDA is now updating all preDecember 2008 special controls 

guidance documents with the revised 

standard language. Revisions to the 

special controls guidance documents 

include clarifying the statement of the 

special controls guidance document’s 

effect by replacing the standard 

language with the following statement: 

‘‘The firm must show that its device 

addresses the issues of safety and 

effectiveness identified in this guidance, 

either by meeting the recommendations 

of this guidance or by some other means 

that provides equivalent assurances of 

safety and effectiveness.’’ 

Special controls guidance documents 

on the following topics have been 

affected: 1

1. Acute Upper Airway Obstruction 

Devices, 

2. Clitoral Engorgement Devices, 

3. Anti-Saccharomyces cerevisiae (S. 

cerevisiae) Antibody (ASCA) Premarket 

Notifications, 

4. Shoulder Joint Metal/Polymer/ 

Metal Nonconstrained or SemiConstrained Porous-Coated Uncemented 

Prosthesis, 

5. B-Type Natriuretic Peptide 

Premarket Notifications, 

6. Home Uterine Activity Monitors, 

7. Pharmacy Compounding Systems, 

8. Tissue Culture Media for Human ex 

vivo Tissue and Cell Culture Processing 

Applications, 

9. Indwelling Blood Gas Analyzers, 

10. Ingestible Telemetric 

Gastrointestinal Capsule Imaging 

System, 

11. Premarket Notifications for 

Automated Differential Cell Counter for 

Immature or Abnormal Blood Cells, 

12. Medical Washers and Medical 

Washer-Disinfectors, 


Emcdonald on DSK2BSOYB1PROD with NOTICES