26132 Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0349] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration Survey of Current 

Manufacturing Practices in the Food 

Industry 

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 June 7, 

2007. 

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: 

202–395–6974. All comments should be 

identified with the OMB control 

number, ‘‘0910–NEW’’ and title, ‘‘FDA 

Survey of Current Manufacturing 

Practices in the Food Industry.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

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. 

FDA Survey of Current Manufacturing 

Practices in the Food Industry—(OMB 

Control Number 0910–NEW) 

The authority for FDA to collect the 

information derives from the FDA 

Commissioner’s authority, as specified 

in section 903(d)(2) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

393(d)(2)). 

FDA’s regulations in 21 CFR part 110 

describe the methods, equipment, 

facilities, and controls for producing 

processed food, hereafter referred to as 

food CGMPs. As the minimum sanitary 

and processing requirements for 

producing safe and wholesome food, 

CGMPs are an important part of 

regulatory control of the nation’s food 

supply. FDA believes that it is necessary 

to revisit and modernize the food 

CGMPs. Since the food CGMPs were last 

revised in 1986, there have been 

significant changes in food production 

technology and important advances in 

the understanding of foodborne 

illnesses. Accordingly, the agency will 

rigorously assess the impacts of any 

modernization policies on food 

facilities. To assess the impacts of the 

modernization policy, information is 

needed to help understand baseline or 

current industry practice. At present, 

however, FDA lacks baseline 

information on the nature of current 

manufacturing practices that would 

serve as part of a regulatory impact 

analysis. 

FDA plans to conduct an Internet 

survey of all domestic FDA-registered 

facilities that primarily manufacture or 

process food and all foreign FDAregistered facilities that primarily 

manufacture or process food, which are 

located in those countries that are the 

largest food exporters to the United 

States: Japan, Canada, China, France, 

Italy, and Mexico. The Internet survey 

may be supplemented by extended case 

study interviews with selected 

respondents from the survey. The 

survey and extended case studies will 

solicit detailed information about six 

key topics relevant to the food CGMPs 

modernization effort: employee training, 

sanitation and personal hygiene, 

allergen controls, process controls, postproduction processing, and 

recordkeeping. Additionally, FDA will 

collect information on establishment 

characteristics, such as facility size and 

industry, which are expected to 

correlate with the presence or absence 

of various manufacturing practices, such 

as electronic recordkeeping, ongoing 

employee training in food safety, and 

product-to-label conformance 

procedures. The case study interviews, 

if conducted, will provide qualitative, 

in-depth information about various 

factors that influence decisions to 

implement these types of manufacturing 

practices, as well as about the 

circumstances that underlie the cost and 

effectiveness of such programs. The 

survey will be sent to every FDAregistered facility in the United States, 

Japan, Canada, China, France, Italy, and 

Mexico that primarily manufactures or 

processes food products and that 

included an e-mail address with its 

registration. Participation will be 

voluntary and the respondent identifiers 

that would permit an association of 

specific responses to specific 

respondents will not be accessible to 

FDA. 

The proposed Internet survey will 

collect the information from 

respondents electronically. With a 

custom-designed online survey system, 

responses will be entered directly into 

a computer database, eliminating the 

need for additional coding and data 

entry operations. Also, the system will 

ensure that conditional questions are 

asked in proper order, freeing the 

respondent from the need to keep track 

of the question order and skip patterns. 

The data quality will also be higher 

because the instrument will contain 

built-in edits, prompts, and data 

validation features. 

The Internet survey method was 

selected due to the following 

considerations: (1) E-mail addresses of 

the respondents are available from the 

FDA Food Facility Registration database 

and are continuously validated by FDA, 

(2) the Internet survey method is the 

least costly to the agency when 

compared with other modes of 

collection and generates the timeliest 

responses, (3) the Internet survey will 

impose a relatively modest reporting 

burden on small entities, and (4) the 

Internet survey method is the only 

feasible method by which FDA may 

survey foreign facilities that export food 

products to the United States. 

The Internet survey includes a pledge 

of confidentiality regarding the 

contractor’s use of the data provided by 

the respondents. All data will be 

collected and compiled by Eastern 

Research Group, Inc. (ERG), an 

independent consulting firm contracted 

by FDA. ERG will provide FDA 

personnel only with a summary of data 

(aggregated statistical data) compiled in 

the course of the study. No reports will 

have information about individual 

facility participation or lack of 

participation, or information that 

enables FDA to determine individual 

responses. In keeping with longstanding 

FDA practice, ERG will not provide 

FDA with identifiers that would permit 

the association of specific responses 

with a given respondent. Responses will 

not be the property of the Federal 

government. The raw data generated by 

the Internet survey will not be owned by 

FDA, will not be an FDA record, and 

will not be provided, or otherwise made 

available, to FDA. 

The key information to be collected 

includes responses to questions about 

the following: (1) Training procedures 

and practices for food production 

managers, production supervisors, 

quality control personnel, sanitation 


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Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices 26133 

and cleaning supervisors, and 

production line employees on the topics 

of food safety, basic cleaning, sanitizing, 

sanitation, personal hygiene, specific 

product and equipment training, and 

allergen control; (2) pest control and 

sanitation procedures and practices for 

food contact surfaces, non-food contact 

surfaces, production areas, and 

warehouses; (3) allergen control 

procedures and practices for soybean or 

soybean-based ingredients, peanuts or 

peanut-based ingredients, finfish and 

crustacea, tree nuts, milk and other 

diary products, eggs, and wheat or 

wheat-based products; (4) process 

controls, including written procedures 

for handling incoming raw materials, 

approving vendors, the calibration of 

operating equipment, pathogen control, 

and a Hazard Analysis and Critical 

Control Point system; (5) recordkeeping 

practices; (6) the primary operation 

characteristics conducted at the facility, 

such as the type of food manufactured 

or processed for human consumption; 

and (7) fresh produce and ready to eat 

packing practice and post harvest 

operations. 

In the Federal Register of September 

14, 2005 (70 FR 54390), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. We received comments from 

three respondents on the 60-day notice 

regarding the collection entitled ‘‘FDA 

Survey of Current Manufacturing 

Practices in the Food Industry.’’ One of 

the respondents’ comments was 

received after the 60-day comment 

period closed and is not addressed. 

Respondents were asked to submit 

comments pertaining to 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. Comments 

outside the scope of these four questions 

are not addressed in this notice. 

(Comment 1) One industry 

respondent wanted assurances from 

FDA that individual company 

information was not subject to release 

under the Freedom of Information Act 

(FOIA). 

(Response 1) The Internet survey 

includes a pledge of confidentiality 

regarding the data provided by the 

respondent. All data will be collected, 

compiled, and owned by ERG, an 

independent consulting firm contracted 

by FDA. ERG is contractually obligated 

to retain the raw data and to not provide 

FDA with access to it. ERG will provide 

FDA personnel only with anonymous 

summary and aggregate statistical data 

compiled during the course of the study; 

ERG is contractually restricted from 

providing FDA with raw or other data 

that has identifiers that would permit 

the association of specific responses to 

a given respondent. Data that FDA does 

not own cannot be requested through 

the FOIA. 

(Comment 2) The respondent requests 

that only one contact be made for each 

individual firm through the parent 

company contact listed on the firm’s 

facility registration form and not to each 

location where the firm has a 

production facility. 

(Response 2) We recognize the 

additional burden this places on a firm 

but because we need current 

information from each manufacturing 

plant we do not believe that we have an 

alternative approach. Not every facility 

processes the same types of foods with 

the same preventive controls even when 

the parent company is the same. We 

need to get an idea of CGMPs at each 

facility location. Having a parent 

company respond could give us 

inaccurate information. 

(Comment 3) The respondent requests 

that each firm (facility) receive only one 

solicitation for information. 

(Response 3) Response to this survey 

is voluntary. For the sake of statistical 

reliability, we must contact nonresponders more than just initially or 

our survey data result could be subject 

to a non-response bias. Non-response 

bias is affected by both the proportion 

of non-responders and the extent to 

which non-respondents and 

respondents differ on key questions 

being measured in the survey. To reduce 

the bias, it is necessary to reduce the 

number of non-responders by contacting 

them multiple times. It also helps to 

obtain information about nonresponders to assess whether their 

socio-demographic characteristics differ 

systematically from survey responders. 

Survey researchers should always try to 

follow up with individuals who do not 

consent to participate in a survey and 

ascertain their reasons for non-response. 

We do recognize that there should be an 

upper limit for the number of times a 

non-responder should be contacted 

before being dropped. From our 

experience, data quality will not be 

improved significantly by more than six 

contacts, so we will set our upper limit 

at six contacts. 

(Comment 4) One respondent opposes 

investigating foreign manufacturers. 

(Response 4) We are not investigating 

foreign manufacturers; we are surveying 

them to get an idea about their 

manufacturing practices. Nearly 20 

percent of all imports into the United 

States are food and food products; 

imported fresh produce and seafood 

make up a large percentage of these 

imports. All food, including imported 

and domestic food, must follow the 

same manufacturing regulations, thus 

information on foreign manufacturing 

processes is necessary and relevant to 

help inform us about how to modernize 

our regulation on CGMPs for food 

facilities. 

At the time of the 60-day notice, 

approximately 45,000 domestic and 

55,000 foreign facilities were registered 

with FDA. Now approximately 126,000 

domestic and 81,000 facilities from 

Japan, Canada, China, France, Italy, and 

Mexico are registered with FDA. 

Recent experience with online 

surveys has shown that fewer 

respondents respond than estimated at 

the time of the 60-day notice. Estimates 

of public burden have been adjusted to 

account for the increase in respondents 

and our estimate of the decrease in 

response rate. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Domestic Facilities 

Screening questions only 17,000 1 17,000 .067 1,139 


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26134 Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Completed survey 44,500 1 44,500 .75 33,375 

Total domestic 61,500 61,500 34,514 

Foreign Facilities 

Screening questions only 14,000 1 14,000 .067 938 

Completed survey 26,000 1 26,000 .75 19,500 

Total foreign 40,000 1 40,000 20,438 

Grand total 101,500 54,952 

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

These estimates of the number of 

respondents and the burden hours per 

response are based on FDA’s registration 

database and FDA and the contractor’s 

experience with previous surveys. The 

respondents are divided into two 

groups: Domestic and foreign. We 

estimate the number of domestic 

facilities at 126,000 based on 

information in the registration database. 

However, we do not expect that all of 

these firms will participate in the 

survey. We anticipate that 

approximately 61,500 facilities will 

participate, which takes into account 

typical response rates to these types of 

surveys and inaccurate contact 

information that facilities have entered 

into the registration database (see http:// 

www.cfsan.fda.gov/~furls/ 

ffregacc.html). Similarly, among the 

81,000 foreign facilities in the 

registration database, we expect that 

40,000 foreign facilities will respond. 

We estimate that it will take a 

respondent 4 minutes (.067 hours) to 

complete the screening questions and 45 

minutes (0.75 hours) to complete the 

entire survey. Prior to the 

administration of the survey, the agency 

plans to conduct a pretest of the final 

survey to identify and resolve potential 

problems. The pretest will be conducted 

with nine participants. 

Dated: May 2, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8783 Filed 5–7–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0363] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Absorbable Hemostatic Device; 

Availability; Reopening of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

June 7, 2007, the comment period for a 

draft guidance entitled ‘‘Class II Special 

Controls Guidance Document: 

Absorbable Hemostatic Device.’’ FDA 

published a notice of availability of the 

draft guidance in the Federal Register of 

October 31, 2006 (71 FR 63774). The 

draft guidance describes a means by 

which the absorbable hemostatic device 

may comply with the requirement of 

special controls for class II devices, if 

the device is reclassified. Elsewhere in 

this issue of the Federal Register, FDA 

is reopening the comment period on a 

proposed rule to reclassify the 

absorbable hemostatic device from class 

III (premarket approval) into class II 

(special controls) 

DATES: Submit written or electronic 

comments on the draft guidance by June 

7, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: 

Absorbable Hemostatic Device’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

David Krause, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–3090, ext. 141. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 31, 

2006 (71 FR 63728), FDA published a 

proposed rule to reclassify the 

absorbable hemostatic device intended 

to produce hemostasis from class III 

(premarket approval) into class II 

(special controls). In the same issue of 

the Federal Register (71 FR 63774), FDA 

published a notice of availability of a 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Absorbable Hemostatic Device.’’ The 

draft guidance describes a means by 

which the absorbable hemostatic device 

may comply with the requirement of 

special controls if they were 

reclassified. FDA invited interested 

persons to comment on the proposed 


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