54390 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 

Dated: September 7, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18163 Filed 9–13–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0349] 

Agency Information Collection 

Activities: Proposed Collection; 

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 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 a notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a proposed survey of current 

manufacturing practices in the food 

industry. The purpose of the proposed 

survey is to improve FDA’s 

understanding of current food industry 

manufacturing practices. The 

information will be used to assess what 

impact, if any, new manufacturing 

requirements would make on the food 

industry. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 14, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

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. 

FDA Survey of Current Manufacturing 

Practices in the Food Industry 

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 part 110 of Title 

21 of the Code of Federal Regulations 

(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 

will 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 

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 FDA-registered 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 their 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 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 54391 

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 with data compiled in the 

course of the study. In keeping with 

longstanding FDA practice, however, 

ERG will not provide FDA with 

identifiers that would permit the 

association of specific responses with a 

given respondent. Under its contract 

with FDA, ERG is precluded from 

releasing to the public any study data or 

findings without FDA’s prior approval. 

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 

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. 

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 

Screener 10,241 1 10,241 .67 683 

Completed Survey 15,361 1 15,361 .75 11,520 

Total Domestic Facilties 36,355 

Foreign Facilities 

Screener 17,565 1 17,565 .67 1,171 

Completed Survey 17,565 1 17,565 .75 13,174 

Total Foreign Facilities 14,345 

Total 50,700 

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

These estimates 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 45,747 based on information 

in the registration database. However, 

we do not expect that all of these firms 

will participate in the survey. It is 

possible that the database will contain 

wrong e-mail addresses or out-ofbusiness facilities, which we estimate 

will reduce the number of respondents 

by 20 percent, or 9,149. We estimate 

that an additional 22 percent, or 10,972, 

will simply not respond to the survey. 

Therefore, the number of domestic 

facilities expected to participate in the 

survey is 25,602. Among the 54,806 

foreign facilities in the registration 

database, 4,620 are expected to be out of 

business or have wrong e-mail addresses 

(or about 8 percent), and 15, 056 (or 

about 27 percent) are not expected to 

respond at all. Therefore, it is expected 

that 35,130 foreign facilities will 

respond. 

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: September 7, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18164 Filed 9–13–05; 8:45 am] 

BILLING CODE 4160–01–S