2124 Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@FDA.HHS.GOV. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 18, 2010 (75 

FR 63834), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0073. The 

approval expires on December 31, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: January 6, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–455 Filed 1–11–11; 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; Proposed Collection; 

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 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 provisions of 

the Voluntary National Retail Food 

Regulatory Program Standards. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 14, 2011. 

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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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 

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. 

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 

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 

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Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 2125 

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 4 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 through 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. 

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 worksheets1.16 

No. 2—Trained Regulatory Staff ................ Self Assessment: (Appendix B–2 and B–4) 1 Completion of CFP Field Training Manual and Documentation of Successful Completion—Field Training Process; completion of summary worksheet of each employee training records2.19.3 

No. 3—HACCP Principles .......................... 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 procedures2.19 

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

No. 6—Compliance Enforcement ............... Self Assessment: (Appendix F 1) ................................................................................... 19 

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.

No. 7—Industry & Community Relations .... Self Assessment: (Appendix G1) Completion of worksheet .......................................... 2 

No. 8—Program Support and Resources ... Self Assessment: (Appendix H 1) Selection and review of establishment files ............. 8 

Total ..................................................... ........................................................................................................................................ 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 types1.

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. 

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2126 Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 

TABLE 3—VERIFICATION AUDIT

Standard Recordkeeping activity Hours per 

record 

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

1 We 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. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

FDA worksheets 2 Number of 

recordkeepers 

Annual 

frequency 

per recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

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

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

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Or 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 4 of this document. 

FDA estimates the reporting burden 

for this collection of information as 

follows: 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1

Form FDA No. Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

3519 ..................................................................................... 500 1 500 0.1 50 

3520 ..................................................................................... 500 1 500 0.1 50 

Conference for Food Protection Training Plan and Log ..... 500 3 1,500 0.1 150 

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

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

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 

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Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 2127 

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: January 5, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–458 Filed 1–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0468] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Patent Term 

Restoration, Due Diligence Petitions, 

Filing, Format, and Content of 

Petitions 

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 February 

11, 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 0910–0233. Also 

include the FDA 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, 

Elizabeth.Berbakos@fda.hhs.gov. 

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. Patent Term 

Restoration, Due Diligence Petitions, 

Filing, Format, and Content of 

Petitions—(OMB Control Number 0910– 

0233)—Extension 

FDA’s patent extension activities are 

conducted under the authority of the 

Drug Price Competition and Patent 

Term Restoration Act of 1984 (21 U.S.C. 

355(j)) and the Animal Drug and Patent 

Term Restoration Act of 1988 (35 U.S.C. 

156). New human drug, animal drug, 

human biological, medical device, food 

additive, or color additive products 

regulated by the FDA must undergo 

FDA safety, or safety and effectiveness, 

review before marketing is permitted. 

Where the product is covered by a 

patent, part of the patent’s term may be 

consumed during this review, which 

diminishes the value of the patent. In 

enacting the Drug Price Competition 

and Patent Term Restoration Act of 1984 

and the Animal Drug and Patent Term 

Restoration Act of 1988, Congress 

sought to encourage development of 

new, safer, and more effective medical 

and food additive products. It did so by 

authorizing the U.S. Patent and 

Trademark Office (PTO) to extend the 

patent term by a portion of the time 

during which FDA’s safety and 

effectiveness review prevented 

marketing of the product. The length of 

the patent term extension is generally 

limited to a maximum of 5 years, and 

is calculated by PTO based on a 

statutory formula. When a patent holder 

submits an application for patent term 

extension to PTO, PTO requests 

information from FDA, including the 

length of the regulatory review period 

for the patented product. If PTO 

concludes that the product is eligible for 

patent term extension, FDA publishes a 

notice that describes the length of the 

regulatory review period and the dates 

used to calculate that period. Interested 

parties may request, under § 60.24 (21 

CFR 60.24), revision of the length of the 

regulatory review period, or may 

petition under § 60.30 (21 CFR 60.30) to 

reduce the regulatory review period by 

any time where marketing approval was 

not pursued with ‘‘due diligence.’’ 

The statute defines due diligence as 

‘‘that degree of attention, continuous 

directed effort, and timeliness as may 

reasonably be expected from, and are 

ordinarily exercised by, a person during 

a regulatory review period.’’ As 

provided in § 60.30(c), a due diligence 

petition ‘‘shall set forth sufficient facts, 

including dates if possible, to merit an 

investigation by FDA of whether the 

applicant acted with due diligence.’’ 

Upon receipt of a due diligence petition, 

FDA reviews the petition and evaluates 

whether any change in the regulatory 

review period is necessary. If so, the 

corrected regulatory review period is 

published in the Federal Register. A 

due diligence petitioner not satisfied 

with FDA’s decision regarding the 

petition may, under § 60.40 (21 CFR 

60.40), request an informal hearing for 

reconsideration of the due diligence 

determination. Petitioners are likely to 

include persons or organizations having 

knowledge that FDA’s marketing 

permission for that product was not 

actively pursued throughout the 

regulatory review period. The 

information collection for which an 

extension of approval is being sought is 

the use of the statutorily created due 

diligence petition. 

Since 1992, 12 requests for revision of 

the regulatory review period have been 

submitted under § 60.24. For 2007, 

2008, and 2009, a total of three, or one 

per year, have been submitted under 

§ 60.24. Two regulatory review periods 

have been altered. During that same 

time period, two due diligence petitions 

were submitted to FDA under § 60.30, 

for an average of fewer than one per 

year. There have been no requests for 

hearings under § 60.40 regarding the 

decisions on such petitions; however, 

for purposes of this information 

collection approval, we are estimating 

that we may receive one submission 

annually. 

In the Federal Register of October 5, 

2010 (75 FR 61493), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received on the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

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