59266 Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Responses per 

respondent 

Average burden 

per response 

(in hours) 

Total burden 

hours 

General Resident .......................... In-depth Interview/phone .............. 600 1 1.5 900 

Screener ....................................... 1,200 1 6/60 120 

Health care provider ..................... In-depth Interview/phone .............. 200 1 .5 100 

Screener ....................................... 400 1 6/60 40 

Community Leader ........................ In-depth Interview/phone .............. 200 1 1.5 300 

Screener ....................................... 400 1 6/60 40 

Elected Official .............................. In-depth Interview/phone .............. 100 1 .5 50 

Industry ......................................... In-depth Interview/phone .............. 100 1 .5 50 

Total ....................................... ....................................................... .......................... .......................... .......................... 1,600 

Dated: September 21, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–24181 Filed 9–24–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0355] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements 

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 October 27, 

2010. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0606. 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. 

Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 

Supplements (OMB Control Number 

0910–0606)—Extension 

On October 25, 1994, the Dietary 

Supplement Health and Education Act 

(DSHEA) (Public Law 103–417) was 

signed into law. DSHEA, among other 

things, amended the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

by adding section 402(g) of the FD&C 

Act (21 U.S.C. 342(g)). Section 402(g)(2) 

of the FD&C Act provides, in part, that 

the Secretary of Health and Human 

Services (the Secretary) may, by 

regulation, prescribe good 

manufacturing practices for dietary 

supplements. Section 402(g) of the 

FD&C Act also stipulates that such 

regulations shall be modeled after 

current good manufacturing practices 

(CGMPs) regulations for food and may 

not impose standards for which there 

are no current, and generally available, 

analytical methodology. Section 

402(g)(1) of the FD&C Act states that a 

dietary supplement is adulterated if ‘‘it 

has been prepared, packed, or held 

under conditions that do not meet 

current good manufacturing practice 

regulations.’’ Under section 701(a) of the 

FD&C Act (21 U.S.C. 371), FDA may 

issue regulations necessary for the 

efficient enforcement of the FD&C Act. 

FDA published a final rule on June 25, 

2007 (72 FR 34752) (the final rule) that 

established, in part 111 (21 CFR part 

111), the minimum CGMPs necessary 

for activities related to manufacturing, 

packaging, labeling, or holding dietary 

supplements to ensure the quality of the 

dietary supplement. 

Records are an indispensable 

component of CGMPs. The records 

required by FDA’s regulations in part 

111 provide the foundation for the 

planning, control, and improvement 

processes that constitute a quality 

control system. Implementation of these 

processes in a manufacturing operation 

serves as the backbone to CGMPs. The 

records will show what is to be 

manufactured; what was, in fact, 

manufactured; and whether the controls 

that the manufacturer put in place to 

control the identity, purity, strength, 

and composition and limits on 

contaminants and to prevent 

adulteration were effective. Further, 

records will show whether and what 

deviations from control processes 

occurred, facilitate evaluation and 

corrective action concerning these 

deviations (including, where necessary, 

whether associated batches of product 

should be recalled from the 

marketplace), and enable a 

manufacturer to assure that the 

corrective action was effective. In 

addition, by requiring records, FDA will 

be able to ensure that industry follows 

CGMPs during manufacturing, 

packaging, labeling, or holding 

operations. The regulations in part 111 

establish the minimum manufacturing 

practices necessary to ensure that 

dietary supplements are manufactured, 

packaged, labeled, or held in a manner 

that will ensure the quality of the 

dietary supplements during 

manufacturing, packaging, labeling or 

holding operations. 

The records requirements of the 

regulations include written procedures 

and records pertaining to: (1) Personnel; 

(2) sanitation; (3) calibration of 

instruments and controls; (4) 

calibration, inspection, or checks of 

automated, mechanical, or electronic 

equipment; (5) maintaining, cleaning, 

and sanitizing equipment and utensils 

and other contact surfaces; (6) water 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 59267 

used that may become a component of 

the dietary supplement; (7) production 

and process controls; (8) quality control; 

(9) components, packaging, labels and 

product received for packaging and 

labeling; (10) master manufacturing and 

batch production; (11) laboratory 

operations; (12) manufacturing 

operations; (13) packaging and labeling 

operations; (14) holding and distributing 

operations; (15) returned dietary 

supplements; and (16) product 

complaints. 

Description of Respondents: 

Manufacturers, dietary supplement 

manufacturers, packagers and 

repackagers, labelers and re-labelers, 

holders, distributors, warehousers, 

exporters, importers, large businesses, 

and small businesses. 

The recordkeeping requirements of 

the regulations in part 111 are set forth 

in each subpart. In table 1 of this 

document we list the annual burdens 

associated with recordkeeping. In the 

table, where the same records are 

mentioned in more than one provision 

of a subpart, we list the burden under 

the provisions corresponding to the 

heading in the final rule, ‘‘Under this 

subpart, what records must you make 

and keep?’’ For some provisions listed in 

table 1, we did not estimate the annual 

frequency of recordkeeping because 

recordkeeping occasions consist of 

frequent brief entries of dates, 

temperatures, monitoring results, or 

documentation that specific actions 

were taken. Information might be 

recorded a few times a day, week, or 

month. When the records burden 

involves frequent brief entries, we 

entered one as the default for the annual 

frequency of recordkeeping. For 

example, many of the records listed 

under § 111.35 in table 1, such as 

§ 111.35(b)(2) (documentation, in 

individual equipment logs, of the date 

of the use, maintenance, cleaning, and 

sanitizing of equipment), involve many 

short sporadic entries over the course of 

the year, varying across equipment and 

plants in the industry. We did not 

attempt to estimate the actual number of 

recordkeeping occasions for these 

provisions, but instead entered an 

estimate of the average number of hours 

per year. We entered the default value 

of 1 as the annual frequency of 

recordkeeping for these and similar 

provisions. For § 111.35, the entry for 

annual frequency is 1 as a default 

representing a large number of brief 

recordkeeping occasions. 

In many rows of table 1 of this 

document, we list a burden under a 

single provision that covers the written 

procedures or records described in 

several provisions. For example, the 

burden of the batch production records 

listed in table 1 under § 111.260 

includes the burden for records listed 

under § 111.255 because the batch 

production records must include those 

records. 

The annual frequency for batch 

production records (and other records 

kept on a batch basis in table 1 of this 

document) equals the annual number of 

batches. The estimated burden for 

records kept by batch includes both 

records kept for every batch and records 

kept for some but not all batches. We 

use the annual number of batches as the 

frequency for records that will not 

necessarily be kept for every batch, such 

as test results or material review and 

disposition records, because such 

records are part of records, if they are 

necessary, that will be kept for every 

batch. 

In the Federal Register of July 14, 

2010 (75 FR 40840), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

111.14 15,000 4 60,000 1 60,000 

111.23 15,000 1 15,000 0 .2 3,000 

111.35 400 1 400 12 .5 5,000 

111.95 250 1 250 45 11,250 

111.140 240 1,163 279,120 1 279,120 

111.180 240 1,163 279,120 1 279,120 

111.210 240 1 240 2 .5 600 

111.260 145 1,408 204,160 1 204,160 

111.325 120 1 120 15 1,800 

111.375 260 1 260 2 520 

111.430 50 1 50 12 .6 630 

111.475 15,000 1 15,000 0 .4 6,000 

111.535 110 4 440 13 .5 5,940 

111.570 240 600 144,000 0 .5 72,000 

Total 929,140 

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


srobinson on DSKHWCL6B1PROD with NOTICES
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 


srobinson on DSKHWCL6B1PROD with NOTICES