10222 Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices 

NFP for a lasagna product and has 

revised the NFPs for the lasagna pairs. 

In addition, FDA changed a product 

category from cookies to donuts edited 

and the NFPs for the new donut product 

pair to add a disclosure of cholesterol. 

(Comment 5) One comment critiqued 

the draft Full Information treatment 

language. The comment criticized the 

one-page summary because: (1) It did 

not identify calories in the discussion of 

fat as a major source of energy and (2) 

it did not relate the calorie contribution 

of fat to that of carbohydrates and 

protein. The comment also criticized the 

information about sources of trans fat 

because it omitted mention of natural 

sources of trans fat in the diet, which 

the comment suggested would help 

ensure factually correct and balanced 

information about sources of trans in the 

diet. The comment questioned the value 

of stating that trans fat extends shelflife 

and has desirable taste characteristics 

since many saturated fat sources are 

relatively shelf stable and have desirable 

taste characteristics. 

(Response) FDA agrees and has 

revised the Full Information treatment 

in response to these concerns. Calories 

and other sources of energy are now 

mentioned in the introductory passage. 

Natural sources of trans fat are now 

mentioned and the similarity between 

trans fat and saturated fat in terms of 

shelflife and taste are now addressed. 

The revised draft will be included in the 

study pretest and further revisions will 

be made if FDA determines they are 

needed based upon pretest results. 

(Comment 6) One comment suggested 

consumer confusion may be caused 

when a NFP for a product discloses 0g 

of trans fat but the ingredient list 

discloses an ingredient that contains 

trans fat, as is permitted by the trans fat 

labeling regulations. The comment 

concluded that FDA should add 

experimental conditions in which this 

occurs. The comment suggested that for 

this situation the study should test 

language for a footnote to the ingredient 

list to explain that there may be a trans 

fat ingredient in the product when the 

NFP shows trans fat as zero. 

(Response) FDA disagrees with the 

proposed addition to the study’s 

experimental conditions. Under existing 

trans fat labeling regulations, food 

manufacturers are allowed to list 

amounts of trans fat less than 0.5 g per 

serving as zero on the NFP. While such 

situations occur in the marketplace and 

are permitted by the trans fat labeling 

regulations, whether this causes 

consumer confusion is an issue outside 

the scope of the proposed research, 

which focuses on the effects of NFP 

footnotes and alternative presentations 

of trans fat information in the NFP on 

consumers’ ability to correctly identify 

more healthful food products. The 

Office of Nutritional Products, Labeling, 

and Dietary Supplements has received 

and responded to a separate letter on 

this topic from the commenter. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Pretest 40 1 40 .25 10 

Study 3,240 1 3,240 .25 810 

Total 820 

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

Dated: February 28, 2007. 

Jeffrey Shuren, 

Associate Commissioner for Policy. 

[FR Doc. E7–3904 Filed 3–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0357] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Procedures for the 

Safe and Sanitary Processing and 

Importing of Fish and Fishery Products 

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 April 6, 

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. 

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. 

Procedures for the Safe and Sanitary 

Processing and Importing of Fish and 

Fishery Products—21 CFR Part 123 

(OMB Control Number 0910–0354)—

Extension 

FDA regulations in part 123 (21 CFR 

part 123) mandate the application of 

hazard analysis and critical control 

point (HACCP) principles to the 

processing of seafood. HACCP is a 

preventive system of hazard control 

designed to help ensure the safety of 

foods. The regulations were issued 

under FDA’s statutory authority to 

regulate food safety, including section 

402(a)(1) and (a)(4) of the Federal Food, 

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

342(a)(1) and (a)(4)), and became 

effective on December 18, 1997. 

Certain provisions in part 123 require 

that processors and importers of seafood 

collect and record information. The 

HACCP records compiled and 

maintained by a seafood processor 

primarily consist of the periodic 

observations recorded at selected 

monitoring points during processing 

and packaging operations, as called for 

in a processor’s HACCP plan (e.g., the 


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Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices 10223 

values for processing times, 

temperatures, acidity, etc., as observed 

at critical control points). The primary 

purpose of HACCP records is to permit 

a processor to verify that products have 

been produced within carefully 

established processing parameters 

(critical limits) that ensure that hazards 

have been avoided. HACCP records are 

normally reviewed by appropriately 

trained employees at the end of a 

production lot or at the end of a day or 

week of production to verify that control 

limits have been maintained, or that 

appropriate corrective actions were 

taken if the critical limits were not 

maintained. Such verification activities 

are essential to ensure that the HACCP 

system is working as planned. A review 

of these records during the conduct of 

periodic plant inspections also permits 

FDA to determine whether the products 

have been consistently processed in 

conformance with appropriate HACCP 

food safety controls. 

Section 123.12 requires that importers 

of seafood products take affirmative 

steps and maintain records that verify 

that the fish and fishery products they 

offer for import into the United States 

were processed in accordance with the 

HACCP and sanitation provisions set 

forth in part 123. These records are also 

to be made available for review by FDA 

as provided in § 123.12(c). 

The time and costs of these 

recordkeeping activities will vary 

considerably among processors and 

importers of fish and fishery products, 

depending on the type and number of 

products involved, and on the nature of 

the equipment or instruments required 

to monitor critical control points. The 

burdens have been estimated using 

typical small seafood processing firms 

as a model because these firms represent 

a significant proportion of the industry. 

Costs were estimated for the collection 

of HACCP data for each type of 

recordkeeping activity using a labor cost 

of $15.00 per hour. 

The burden estimate in table 1 of this 

document includes only those 

collections of information under the 

seafood HACCP regulations that are not 

already required under other statutes 

and regulations. The estimate also does 

not include collections of information 

that are a usual and customary part of 

businesses’ normal activities. For 

example, the tagging and labeling of 

molluscan shellfish (21 CFR 1240.60) is 

a customary and usual practice among 

seafood processors. Consequently, the 

estimates in table 1 of this document 

account only for information collection 

and recording requirements attributable 

to part 123. 

Upon reevaluation of the burden 

estimates for part 123, we have 

determined that PRA requirements do 

not apply to § 123.10. 

In the Federal Register of September 

26, 2006 (71 FR 56154), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section2 No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping3

Total Annual 

Records 

Hours per 

Record4 Total Hours 

123.6(a), (b), and (c) 275 1 275 16.00 4,400 

123.6(c)(5) 5,500 4 22,000 0.30 6,600 

123.8(a)(1) and (c) 5,500 1 5,500 4.00 22,000 

123.12(a)(2)(ii) 1,100 80 88,000 0.20 17,600 

123.6(c)(7) 5,500 280 1,540,000 0.30 462,000 

123.7(d) 2,200 4 8,800 0.10 880 

123.8(d) 5,500 47 258,500 0.10 25,850 

123.11(c) 5,500 280 1,540,000 0.10 154,000 

123.12(c) 1,100 80 88,000 0.10 8,800 

123.12(a)(2) 55 1 55 4.00 220 

TOTAL 702,350 

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

2These estimates include the information collection requirements in the following sections: 

§ 123.16—Smoked Fish—process controls (see § 123.6(b)) 

§ 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b)) 

§ 123.28(c) and (d)—Records–molluscan shellfish (see § 123.6(c)(7)) 3Based on an estimated 280 working days per year. 

4Estimated average time per 8-hour workday unless one-time response. 


sroberts on PROD1PC70 with NOTICES
10224 Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices 

Dated: February 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3915 Filed 3–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0062] 

Guidance on Drug Safety 

Information—Food and Drug 

Administration’s Communication to 

the Public; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance titled ‘‘Drug 

Safety Information—FDA’s 

Communication to the Public.’’ This 

guidance describes FDA’s current 

approach to communicating important 

drug safety information, including 

emerging drug safety information, to the 

public and the factors that influence 

when such information is 

communicated. This guidance was 

developed in connection with FDA’s 

Drug Safety Initiative. This guidance is 

the final version and supersedes the 

previously issued draft guidance titled 

‘‘FDA’s Drug Watch for Emerging Drug 

Safety Information’’ (70 FR 24606, May 

10, 2005). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Paul 

J. Seligman, Associate Director for 

Safety Policy and Communication, 

Center for Drug Evaluation and Research 

(HFD–001), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–443–5570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Drug Safety 

Information—FDA’s Communication to 

the Public.’’ This guidance describes 

FDA’s current approach to 

communicating important drug safety 

information, including emerging drug 

safety information, to the public and the 

factors that influence when such 

information is communicated. 

For many years, FDA has provided 

information on drug risks and benefits 

to healthcare professionals and patients 

when that information has generated a 

specific concern or prompted a 

regulatory action, such as a revision to 

the drug product’s labeling. FDA has 

been reexamining its risk 

communication program, including how 

and when we communicate emerging 

drug safety information to the public. 

More recently, FDA has begun taking a 

more comprehensive approach to 

making information on potential drug 

risks available to the public earlier, in 

some cases while the agency still is 

evaluating whether any regulatory 

action is warranted. FDA believes that 

timely communication of important 

drug safety information will give 

healthcare professionals, patients, 

consumers, and other interested persons 

access to the most current information 

concerning the potential risks and 

benefits of a marketed drug, helping 

them to make more informed individual 

treatment choices. 

FDA’s risk communication efforts are 

part of a larger drug safety initiative that 

began in November 2004, when FDA 

announced an initiative to strengthen 

the safety program for marketed drugs. 

This initiative included the following: 

(1) Sponsoring an independent study by 

the Institute of Medicine of the National 

Academies of the effectiveness of the 

drug safety system, with emphasis on 

postmarketing risk assessment and 

surveillance; (2) conducting workshops 

and Advisory Committee meetings 

regarding complex drug safety and risk 

management issues, including emerging 

concerns; and (3) publishing three risk 

management guidances. FDA 

augmented its drug safety initiative in 

February 2005 by creating an 

independent Drug Safety Oversight 

Board to enhance oversight of drug 

safety decision making within the 

Center for Drug Evaluation and Research 

(CDER). 

In May 2005, FDA issued a draft 

guidance titled ‘‘FDA’s Drug Watch for 

Emerging Drug Safety Information’’ (70 

FR 24606, May 10, 2005). The draft 

guidance described a proposal to 

establish a new communication 

channel, called the ‘‘Drug Watch’’ Web 

page, to provide information to the 

public on emerging drug safety issues. 

In December 2005, FDA held a public 

hearing regarding ‘‘FDA’s 

Communication of Drug Safety 

Information’’ that examined the various 

risk communication tools employed by 

FDA. FDA has carefully reviewed the 

comments it received on the draft 

guidance (30 comments were submitted 

to the public docket) and during the 

public hearing. This final version of the 

guidance reflects our consideration of 

these comments, as well as our 

experience with posting emerging drug 

safety information. 

Due to potential confusion between 

the proposed ‘‘Drug Watch’’ and FDA’s 

existing ‘‘MedWatch’’ program, FDA no 

longer plans to use the name ‘‘Drug 

Watch’’ to describe the Web page that 

contains drug safety information. We 

have identified drugs that have been the 

subject of a Public Health Advisory or 

an Alert on a single Web page, the Index 

to Drug-Specific Information, linked 

from FDA’s Web site. This is part of our 

ongoing effort to use and enhance 

existing FDA communications 

mechanisms to better convey important 

drug safety information to the public. In 

addition, we have revised this guidance 

to describe the various methods FDA 

currently uses to communicate 

established and emerging drug safety 

information to the public. It should be 

noted that we will continue to evaluate 

and enhance the effectiveness of the 

various methods we use to 

communicate about important drug 

safety issues, including the mechanisms 

described in this guidance and the 

presentation of drug safety information 

on the Agency Web sites (http:// 

www.fda.gov and http://www.fda.gov/ 

cder). We intend to update this 

guidance, as appropriate, to reflect any 

substantial modifications to our 

communication of drug safety 

information to the public. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’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. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 


sroberts on PROD1PC70 with NOTICES