59268 Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 

1Fermented foods, such as some kinds of 

sauerkraut, cucumber pickles, and green olives, are 

low-acid foods subjected to the action of acidproducing microorganisms to reduce the pH of the 

food. Not all fermented foods meet the definition 

of ‘‘acidified foods’’ in 21 CFR 114.3(b). However, 

some fermented foods that contain acid are also 

acidified foods. We also note that fermented dairy 

products, such as yogurt, belong to a separate 

category that is not relevant to the fermented foods 

that are discussed in this guidance. 

The burden estimates in table 1 of this 

document are based on those in the final 

rule, which were based on our 

institutional experience with other 

CGMP requirements and on data 

provided by Research Triangle Institute 

(RTI) in the ‘‘Survey of Manufacturing 

Practices in the Dietary Supplement 

Industry’’ cited in that rule. 

The estimates in table 1 of the number 

of firms affected by each provision of 

part 111 are based on the percentage of 

manufacturers, packagers, labelers, 

holders, distributors, and warehousers 

that reported in the survey that they 

have not established written standard 

operating procedures (SOPs) or do not 

maintain records that were later 

required by the final rule. Because we 

do not have survey results for general 

warehouses, we entered the 

approximate number of facilities in that 

category for those provisions covering 

general facilities. For the dietary 

supplement industry, the survey 

estimated that 1,460 firms would be 

covered by the final rule, including 

manufacturers, packagers, labelers, 

holders, distributors, and warehousers. 

The time estimates include the burden 

involved in documenting that certain 

requirements are performed and in 

recordkeeping. We used an estimated 

annual batch production of 1,408 

batches per year to estimate the burden 

of requirements that are related to the 

number of batches produced annually, 

such as § 111.260, ‘‘What must the batch 

production record include?’’ The 

estimate of 1,408 batches per year is 

near the midpoint of the number of 

annual batches reported by survey 

firms. 

The length of time that CGMP records 

must be maintained is set forth in 

§ 111.605. Table 1 of this document 

reflects the estimated burdens for 

written procedures, record maintenance, 

periodically reviewing records to 

determine if they may be discarded, and 

for any associated documentation for 

that activity for records that are required 

under part 111. We have not included 

a separate estimate of burden for those 

sections that require maintaining 

records in accordance with § 111.605, 

but have included those burdens under 

specific provisions for keeping records. 

For example, § 111.255(a) requires that 

the batch production records be 

prepared every time a batch is 

manufactured, and § 111.255(d) requires 

that batch production records be kept in 

accordance with § 111.605. The 

estimated burdens for both § 111.255(a) 

and (d) are included under § 111.260 

(what the batch record must include). 

Dated: September 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24105 Filed 9–24–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0434] 

Draft Guidance for Industry: Acidified 

Foods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Guidance for Industry: Acidified 

Foods.’’ The draft guidance, when 

finalized, will complement FDA’s 

regulations regarding acidified foods, 

including regulations for specific 

current good manufacturing practice 

(CGMP), establishment registration, and 

process filing. The draft guidance is 

intended to assist commercial food 

processors in determining whether their 

food products are subject to these 

regulations. The draft guidance also is 

intended to assist processors of acidified 

foods in ensuring safe manufacturing, 

processing, and packing processes and 

in employing appropriate quality 

control procedures. Under the draft 

guidance, processors of non-acidified 

foods (e.g., some acid foods or 

fermented foods) who are not subject to 

the acidified food regulations may 

choose to voluntarily register and file 

scheduled processes with us using 

existing forms (Forms FDA 2541 and 

2541a). If such processors voluntarily 

submit this information, we plan to 

make the results of any FDA evaluation 

of the information available to our 

investigators, e.g., during inspections of 

food facilities and during evaluations of 

foods offered for import. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

concerning the draft guidance by 

December 27, 2010. Submit either 

electronic or written comments 

concerning the collection of information 

provisions by December 27, 2010. 

ADDRESSES: Submit electronic 

comments on the draft guidance and the 

proposed collection of information 

provisions 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. Submit 

written requests for single copies of the 

draft guidance entitled ‘‘Guidance for 

Industry: Acidified Foods’’ to the Office 

of Food Safety, Center for Food Safety 

and Applied Nutrition (HFS–302), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request, or fax your request to 301–436– 

2669. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance 

document: Michael Mignogna, 

Center for Food Safety and Applied 

Nutrition (HFS–302), Food and 

Drug Administration, 5100 Paint 

Branch Parkway, College Park, MD 

20740, 301–436–1565. 

With regard to the information 

collection: Denver Presley, Jr., 

Office of Information Management, 

Food and Drug Administration, 

1350 Piccard Dr., PI50–400B, 

Rockville, MD 20857, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Guidance for 

Industry: Acidified Foods.’’ The draft 

guidance, when finalized, will 

complement FDA’s regulations 

regarding acidified foods, including 

regulations for specific CGMP, 

establishment registration, and process 

filing. The draft guidance is intended to 

assist commercial food processors in 

determining whether their food 

products are subject to these 

regulations. Under the draft guidance, 

processors of acid foods and fermented 

foods who conclude that such foods 

they produce are not also acidified 

foods1 may voluntarily register and file 

scheduled processes with us using 

existing forms (Forms FDA 2541 and 

2541a) for acidified foods. Processors of 


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Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 59269 

acid foods and fermented foods, which 

foods are not also acidified foods, would 

not be subject to the acidified food 

regulations. When processors of such 

acid foods or fermented foods 

voluntarily register and file scheduled 

processes with us using existing forms, 

we plan to make the results of any FDA 

evaluation of such information available 

to our investigators, e.g., during 

inspections of food facilities and during 

evaluations of foods offered for import, 

to facilitate investigators’ decisions 

about the regulatory status of those food 

products. The draft guidance 

recommends that such processors, who 

voluntarily file scheduled processes 

with us, file a single scheduled process 

for each product, rather than filing a 

separate form for each container size, as 

required for processors of acidified 

foods. The draft guidance also is 

intended to assist processors of acidified 

foods in ensuring safe manufacturing, 

processing, and packing processes and 

in employing appropriate quality 

control procedures. FDA is issuing this 

draft guidance as a level 1 draft 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 

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. 

Title: Recommendations for 

Establishment-Specific Written Quality 

Control Plans and Recordkeeping for 

Acidified Foods, and Voluntary 

Registration and Process Filing. 

Description of respondents: The likely 

respondents to this proposed collection 

of information are processors of 

acidified foods as well as processors of 

foods that may not be acidified foods 

who voluntarily choose to provide us 

with information about these foods. 

Description: The draft guidance is 

intended to assist processors of acidified 

foods in ensuring safe manufacturing, 

processing, and packing processes and 

in employing appropriate quality 

control procedures. Further, this 

guidance notes that processors who are 

not certain as to whether specific food 

products, including foods that may be 

acid or fermented foods, are acidified 

foods subject to registration and process 

filing requirements may provide us with 

information about these products by 

voluntarily submitting Forms FDA 2541 

and 2541a. This guidance also 

recommends that firms prepare a 

written plan to investigate product lots 

for signs of spoilage and document any 

investigation and corrective actions 

relevant to spoilage. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 

§ 108.25 (21 CFR 108.25) and part 114 

(21 CFR part 114) have been approved 

under OMB control no. 0910–0037. 

Under the draft guidance, when 

processors voluntarily submit Forms 

FDA 2541 and 2541a for foods that they 

conclude are not acidified foods, we 

intend to continue to evaluate the 

process information to determine 

whether it is consistent with a 

processor’s conclusion that a food is not 

an acidified food. The burden approved 

under OMB control no. 0910–0037 does 

not include the burden associated with 

voluntary reporting. 

The burden approved under OMB 

control no. 0910–0037 also does not 

include the burden associated with the 

recommendations in the draft guidance 

to prepare a written plan (the 

establishment-specific written plan) that 

includes quality control procedures 

with respect to spoilage and to 

document spoilage events if they occur. 

We estimate the recordkeeping burden 

of the draft guidance by assuming that 

those in the industry that process 

acidified foods and that do not currently 

follow the recommendations put forth 

in the draft guidance will find it of 

value to do so. The conservative 

assumptions and estimates made in this 

analysis regarding the recordkeeping 

burden are intended to provide the 

upper bound estimates of anticipated 

impact of the guidance on the acidified 

food industry and others that choose to 

file voluntary submissions with FDA. 

These burdens would be realized if 

every operation, plant, or processor of 

acidified foods that does not already 

follow the recommendations of the draft 

guidance would choose to do so. 

We estimate the proposed collection 

of information consists of one-time and 

recurring recordkeeping burdens, 

summarized in table 1 of this document. 

We estimate the reporting burden of 

the draft guidance by assuming that 

processors who conclude that their 

specific food products are acid foods or 

fermented foods, rather than acidified 

foods subject to registration and process 

filing requirements, will find it of value 

to provide us with information about 

their products by voluntarily submitting 

Forms FDA 2541 and 2541a. The 

conservative assumptions and estimates 

made in this analysis regarding the 

reporting burden are intended to 

provide the upper bound estimates of 

anticipated impact of the guidance on 

such processors. These burdens would 

be realized if every operation, plant, or 

processor that concludes that specific 

food products are acid or fermented 

foods that are not also acidified foods, 

would choose to submit Forms FDA 

2541 and 2541a. We estimate that the 

proposed collection of information 

consists of one-time and recurring 

reporting burdens, summarized in table 

2 of this document. 

Current Information Available to FDA 

The existing reporting requirements 

in § 108.25 provide us with information 

about the acidified foods industry, 

including the total number of 

establishment registrations, the annual 

number of establishment registrations, 

and the annual number of processes 

filed. As of February 4, 2010, there are 

a total of 4,872 establishments registered 

with FDA in accordance with § 108.25 

as commercial processors of acidified 

foods. 


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2We began implementing an electronic filing 

system in 2004 and used information available in 

that system for this analysis. 

The available data for the past 6 years 

(2004 through 2009)2 indicate that, on 

average, there are 6,754 process filings 

submitted by an average of 892 acidified 

foods establishments each year. In 

addition, since 2004, when we began 

implementing an electronic filing 

system, approximately 750 

establishments that registered using 

Form FDA 2541 submitted process 

filings to us for food products that we 

determined were not covered by either 

part 113 (21 CFR part 113) or part 114. 

The available information includes the 

number of establishments that 

submitted such filings, but not the 

number of filings. 

We also have data on estimated 

reporting burdens, available to us from 

our most recent analysis of the reporting 

burden under parts 113 and 114 (OMB 

control no. 0910–0037; 73 FR 11649 at 

11650, March 4, 2008). In that analysis, 

we estimated that there are 8,950 

establishments that keep records on an 

annual basis as processors of acidified 

foods or low-acid canned foods (LACF), 

that 515 establishments submit a 

registration form (Form FDA 2541) on 

an annual basis, for either acidified 

foods or LACF; that it takes 0.17 hours 

to complete Form FDA 2541; that 1,489 

establishments each submit 8.62 process 

filings (Form FDA 2541a) on an annual 

basis; and that it takes 0.33 hours to 

complete Form FDA 2541a. We use this 

information to estimate the reporting 

burden associated with the draft 

guidance. 

In addition to establishment 

registration and process filing under 

§ 108.25, acidified food establishments 

also must promptly report to us any 

instance of spoilage when the nature of 

the spoilage is such that it has potential 

health-endangering significance and any 

lot of such food has in whole or in part 

entered distribution in commerce 

(§ 108.25(d)). In the period from 2004 to 

January 2010, we received 1 report of 

spoilage of a commercially distributed 

acidified food. Therefore, for this 

analysis, we assume that such spoilage 

events are rare. 

Recordkeeping Burden 

Establishment-Specific Written Plan 

Including Quality Control Procedures 

for Acidified Foods (One-Time Burden): 

Currently, acidified foods 

establishments must employ 

appropriate quality control procedures 

to ensure that finished foods do not 

present a health hazard (§ 114.80(a)). To 

assist manufacturers in employing 

appropriate quality control procedures 

under § 114.80(a), the draft guidance 

recommends that each acidified food 

establishment prepare a written plan 

(the establishment-specific written plan) 

that includes quality control procedures 

with respect to spoilage, regardless of 

whether the spoilage has potential 

health-endangering significance. 

Currently existing models (e.g., Ref. 1) 

suitable for use in developing such a 

written plan are readily available to 

acidified foods establishments. 

Because we rarely receive reports 

under § 108.25(d) regarding spoilage of 

commercially distributed acidified 

foods with potential health-endangering 

significance, for this analysis we assume 

that the quality control procedures of all 

acidified foods establishments currently 

address spoilage. Because the potential 

health consequences of spoilage may 

not be apparent in the initial stages of 

an investigation of spoilage, we assume 

that these establishments address 

spoilage regardless of the potential for 

health consequences. We also assume 

that the quality control procedures of 80 

percent of registered establishments 

address spoilage through an 

establishment-specific written plan such 

as the one recommended in the draft 

guidance. We further assume that the 

quality control procedures of the 

remaining 20 percent of registered 

establishments (i.e., 4,872 x 0.20 = 

974.4, rounded to 974 establishments) 

address spoilage by relying on a 

generally available document (e.g., Ref. 

1), the establishment’s unwritten 

procedures, or a combination of both. 

Based on our experience with quality 

control procedures, we estimate it 

would take 8 hours for an acidified 

foods establishment to prepare an 

establishment-specific written plan. If 

all of the 974 registered establishments 

that do not currently have an 

establishment-specific written plan 

develop such a plan, the associated 

recordkeeping burden would be 7,792 

hours (974 establishments x 8 hours/ 

establishment). This would be a onetime recordkeeping burden. Table 1 of 

this document includes the estimated 

one-time recordkeeping burden 

associated with preparation of 

establishment-specific written plans. 

Documentation of Spoilage for 

Acidified Foods (Recurring Burden): 

The draft guidance recommends that an 

acidified food establishment document 

all investigations and corrective actions 

relevant to spoilage. We assume that an 

acidified food establishment that 

currently has an establishment-specific 

written plan in place to address spoilage 

also currently documents investigations 

and corrective actions relevant to 

spoilage. We assume that spoilage 

problems are relatively rare and, 

therefore, estimate that one spoilage 

event per establishment occurs every 5 

years. Accordingly, we estimate 195 

spoilage events requiring recordkeeping 

will occur (974 establishments that do 

not currently have an establishmentspecific written plan x 0.2 events/ 

establishment = 194.8 events, rounded 

to 195). Assuming that establishments 

follow procedures such as those in Ref. 

1, and based on our experience with 

investigations and corrective actions, we 

estimate it would take 2 hours to 

document a spoilage event. Thus, we 

estimate a recurring recordkeeping 

burden of 390 hours (195 events x 2 

hours/event = 390 hours). Table 1 of this 

document includes the estimated 

recurring recordkeeping burden 

associated with documenting 

investigations of spoilage events. 

TABLE 1.—ESTIMATED ONE-TIME AND RECURRING RECORDKEEPING BURDEN1

Activity No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Quality control plan to address 

spoilage2 974 1 974 8.00 7,792 

Spoilage event documentation 195 1 195 2.00 390 

Total one-time burden 7,792 


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Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 59271 

TABLE 1.—ESTIMATED ONE-TIME AND RECURRING RECORDKEEPING BURDEN1—Continued 

Activity No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Total recurring burden 390 

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

2One-time recordkeeping burden. 

Reporting Burden 

Voluntary Registration (Form FDA 

2541) (One-Time and Recurring 

Burdens): Currently, we place 

information documenting whether 

acidified food establishments have 

made appropriate submissions on Forms 

FDA 2541 and 2541a in an acidified 

food database that is readily available to 

our investigators who inspect food 

facilities or evaluate foods offered for 

import. This information facilitates 

decisions by our investigators about the 

regulatory status of specific food 

products. 

In our experience, establishments are 

cautious about decisions they make 

about the regulatory status of their 

products, and many establishments that 

process non-acidified fermented foods 

and/or acid foods have contacted us 

with information about their facilities 

and the products they make. For 

example, our records show that, since 

2004, we have informed approximately 

750 different registered establishments 

that submitted electronic process filings 

that a food product that was the subject 

of a process filing was not covered by 

either part 113 (as a low-acid food) or 

part 114 (as an acidified food). In the 

past, we did not add information about 

these products to the acidified foods 

databases that are available to our 

investigators. 

The draft guidance clarifies that 

establishments that conclude that the 

foods they process are acid foods or 

fermented foods that are not also 

acidified foods, may voluntarily register 

and file scheduled processes with us 

using Forms FDA 2541 and 2541a. As 

we do currently, if we receive 

information from such establishments, 

we would evaluate the submitted 

information to determine whether it is 

consistent with the establishment’s 

conclusion that a product is not an 

acidified food. We plan to make the 

results of these evaluations available to 

our investigators, for example, during 

inspections of food facilities and during 

evaluations of foods offered for import. 

If we conclude that the submitted 

information is not consistent with the 

processor’s conclusion that its products 

are not acidified foods, we may request 

additional information to assist us in 

evaluating the processor’s conclusion 

about its products or take other action 

as appropriate. From our past 

experience, we believe that many 

processors of foods that may be acid 

foods or fermented foods that are not 

also acidified foods would choose to 

submit information to us on Forms FDA 

2541 and 2541a because doing so would 

facilitate decisions by our investigators 

about the regulatory status of specific 

food products. 

We estimate that there are 3,000 

establishments that process products 

that they would conclude are acid foods 

or fermented foods that are not also 

acidified foods—4 times the 

approximate number of registered 

establishments (750) that have 

submitted process filings to FDA for 

food products we determined were not 

covered by either part 113 or part 114. 

We assume that all 3,000 establishments 

are not already registered as processors 

of acidified foods or LACF. Because 750 

of these establishments have already 

registered voluntarily using Form FDA 

2541, we estimate that the number of 

establishments that may register for the 

first time under the draft guidance is 

2,250 establishments (3,000 - 750 = 

2,250), resulting in a one-time reporting 

burden of 383 hours (2,250 

establishments x 0.17 hours/ 

establishment = 382.5 hours, rounded to 

383 hours). Table 2 of this document 

includes the estimated one-time 

reporting burden for establishments that 

conclude that their foods are acid foods 

or fermented foods that are not also 

acidified foods, and voluntarily register 

their facilities in the first year after the 

draft guidance is issued. 

After this initial registration, we also 

estimate that, on average, a number of 

establishments equal to 6 percent of the 

3,000 total estimated establishments 

that will voluntarily register in the first 

year (i.e., 0.06 x 3,000 establishments = 

180 establishments) will voluntarily 

register using Form FDA 2541 each year, 

resulting in an annual reporting burden 

of 31 hours (180 establishments x 0.17 

hours/establishment = 30.6 hours, 

rounded to 31 hours). Proportionally, 

this would be comparable to the current 

percentage of acidified foods and LACF 

establishments that, on average, register 

using Form FDA 2541 each year (515 

establishments that register on an 

annual basis/8,950 establishments that 

keep records on an annual basis x 100 

= 5.75 percent rounded to 6 percent). 

Table 2 of this document includes the 

estimated recurring annual reporting 

burden for establishments that process 

foods that they conclude are acid foods 

or fermented foods that are not also 

acidified foods, and that would 

voluntarily register their facilities. 

Voluntary Process Filing (Form FDA 

2541a) (One-Time and Recurring 

Burdens): As discussed, we do not have 

information about the number of 

process filings voluntarily submitted by 

firms that registered their 

establishments but whose food products 

we determined were not covered by 

either part 113 or part 114. However, we 

do have information that, on average, 

over the 6-year period from 2004 

through 2009, there was a total of 6,754 

annual process filings submitted by an 

average of 892 acidified foods 

establishments each year, and that there 

were 4,872 registered acidified foods 

establishments; from this information 

we calculate that, on average, 18 percent 

of registered acidified foods 

establishments submit process filings 

each year (892 establishments/4,872 

establishments x 100 = 18.3 percent, 

rounded to 18 percent). To be 

conservative, we also estimate that, on 

average, acidified foods establishments 

submitted process filings for 3 container 

sizes per product and that the total 

number of products reported by 

acidified foods establishments each year 

during that period was thus 2,251 

products (6,754 process filings/3 

container sizes/product = 2,251.33 

products, rounded to 2,251 products). 

For the purpose of this analysis, we 

estimate that, on average, 18 percent of 

establishments that process foods that 

they conclude are acid foods or 

fermented foods that are not also 

acidified foods in a given year will 

submit process filings; i.e., 540 

establishments (0.18 x 3,000 

establishments = 540 establishments). 

To be conservative, we also estimate 

that, on average, the 540 establishments 

that would submit process filings in a 

given year will submit process filings 

for twice as many products as would be 

submitted by acidified foods 

establishments; per the 


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recommendations in the draft guidance, 

these establishments could submit a 

single process form that covers all 

container sizes of a product. Thus, the 

estimated number of annual voluntary 

process filings is 2,725 process filings 

(2,251 products/892 establishments x 

540 establishments x 2 = 2,725.4 process 

filings, rounded to 2,725). On average, 

we calculate that the annual frequency 

of reporting would be 5 process filings 

(2,725 process filings/540 

establishments = 5.04, rounded to 5). 

For the purpose of this analysis, we use 

the rounded number of process filings 

(i.e., 5) and, thus, calculate that the 

estimated recurring reporting burden for 

submission of Form 2541a is 2,700 

process filings rather than 2,725 process 

filings (540 establishments x 5 process 

filings per establishment = 2,700 

process filings), resulting in an annual 

reporting burden of 891 hours (2,700 

process filings x 0.33 hours/process 

filing = 891 hours). Table 2 of this 

document includes the estimated onetime and recurring reporting burden for 

establishments that voluntarily submit 

process filings for foods that they 

conclude are acid foods or fermented 

foods that are not also acidified foods. 

We also estimate that all 3,000 

establishments that process foods that 

they conclude are acid foods or 

fermented foods that are not also 

acidified foods and voluntarily register 

their establishments will submit a total 

of 30,000 process filings in the first 

year—i.e., twice as many process filings 

as would be submitted, on average, by 

any given establishment on an annual 

basis (2 x 5 process filings/ 

establishment on an annual basis x 

3,000 establishments = 30,000 process 

filings), resulting in a one-time reporting 

burden of 9,900 hours (30,000 process 

filings x 0.33 hours/establishment = 

9,900 hours). Table 2 of this document 

includes the estimated one-time 

reporting burden for establishments that 

voluntarily submit process filings for 

fermented foods and/or acid foods. 

TABLE 2.—ESTIMATED ONE-TIME AND RECURRING REPORTING BURDEN1

Activity No. of 

Reporters 

Annual Frequency 

per Reporter 

Total Annual 

Records 

Hours per 

Record Total Hours 

Registration (Form FDA 2541)2 2,250 1 2,250 0.17 383 

Registration (Form FDA 2541) 180 1 180 0.17 31 

Process filing (Form FDA 

2541a)2 3,000 10 30,000 0.33 9,900 

Process filing (Form FDA 

2541a) 540 5 2,700 0.33 891 

Total one-time burden 10,283 

Total recurring burden 922 

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

2One-time reporting burden. 

III. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov or at http://

www.fda.gov/FoodGuidances. 

V. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen between 9 a.m. and 4 

p.m., Monday through Friday. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to Web site after this document 

publishes in the Federal Register.) 

1. Codex Alimentarius Commission, 

Recommended International Code of 

Hygienic Practice for Low and Acidified Low 

Acid Canned Foods CAC/RCP 23–1979, Rev. 

2 (1993), Available at http://www.codex

alimentarius.net/download/standards/24/

CXP_023e.pdf, Accessed and printed on June 

17, 2008. 

Dated: September 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24089 Filed 9–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1820–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application from 

a Hospital Requesting Waiver for 

Organ Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: A hospital has requested a 

waiver of statutory requirements that 

would otherwise require the hospital to 

enter into an agreement with its 

designated Organ Procurement 

Organization (OPO). The request was 

made in accordance with section 

1138(a)(2) of the Social Security Act (the 

Act). This notice requests comments 

from OPOs and the general public for 

our consideration in determining 

whether we should grant the requested 

waiver. 


srobinson on DSKHWCL6B1PROD with NOTICES