7274 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

1BLS Occupation Employment and Wages, May 

2006, by occupation, for all industries (http:// 

www.bls.gov). Wage ($46.50) includes mean hourly 

wage of $33.22 for Standard Occupational 

Classification 15–0000, computer and mathematics 

occupations, all industries; we add 40 percent to 

account for benefits. 

the statutory requirements of section 

512(l)(3) of the act.1 For subsequent 

years, the preparation of the report 

should take approximately 3 hours. 

Thus, the total cost in subsequent years 

would be $139.50. 

Regarding the recordkeeping burden 

associated with this collection of 

information, FDA believes that most of 

the necessary information for the annual 

report required to be submitted under 

section 512(l)(3) of the act is already 

collected and maintained by animal 

drug manufacturers under existing 

requirements. 

Animal drug manufacturers are 

already required to maintain 

distribution records for their drug 

products to comply with FDA’s current 

good manufacturing practice regulations 

under § 211.196 (21 CFR § 211.96) (OMB 

Control No. 0910–0139), and to comply 

with regulations for periodic drug 

experience reports under 

§ 514.80(b)(4)(i) (OMB Control No. 

0910–0284). Therefore, FDA believes 

that manufacturers of animal drugs 

already possess the computers, software, 

and additional equipment necessary to 

collect and maintain the necessary 

records and to make reports. 

Section 512(l)(3) of the act differs 

from § 514.80(b)(4)(i) in that it requires 

that records include separate 

information for each month of the 

calendar year. Under § 211.196 (OMB 

Control No. 0910–0139), manufacturers 

currently are required to maintain 

distribution records that include the 

dosage form and date the drug is 

distributed. Additionally, FDA believes 

that manufacturers already keep 

detailed records of the dates when 

antimicrobial drugs are distributed for 

marketing and recall purposes from 

which monthly reports can be prepared 

as part of their usual and customary 

practice. However, FDA estimates an 

additional hourly burden required by 

section 512(l)(3) of the act as shown in 

table 2 of this document. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3029 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0390] (formerly 

Docket No. 2004N–0503) 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance on 

Consultation Procedures: Foods 

Derived From New Plant Varieties 

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 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 

the information collection provisions of 

FDA’s consultation procedures for foods 

derived from new plant varieties, 

including the information collection 

provisions in the guidance entitled 

‘‘Consultation Procedures: Foods 

Derived From New Plant Varieties,’’ and 

in Form FDA 3665 entitled ‘‘Final 

Consultation For Food Derived From a 

New Plant Variety (Biotechnology Final 

Consultation),’’ which developers may 

use to prepare the final consultation in 

a standard format. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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 

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. In the Federal 

Register of November 24, 2004 (69 FR 

68379), FDA published a previous 60- 

day notice requesting public comment 

on this proposed collection of 

information. FDA is publishing this 

notice to update comments. Comments 

previously submitted to the Division of 

Dockets Management do not need to be 

resubmitted because all such comments 

that are responsive to the comment 

request will be summarized and 

responded to in the Information 

Collection Request, i.e. 30-day notice, 

submitted to OMB. 

Guidance on Consultation Procedures: 

Foods Derived From New Plant 

Varieties 

Since 1992, when FDA issued its 

Statement of Policy: Foods Derived from 

New Plant Varieties (the 1992 policy) 

(57 FR 22984, May 29, 1992), FDA has 

encouraged developers of new plant 

varieties, including those varieties that 

are developed through biotechnology, to 

consult with FDA during the plant 

development process to discuss possible 

scientific and regulatory issues that 

might arise. In the 1992 policy, FDA 

explained that, under the Federal Food, 

Drug, and Cosmetic Act (the act), 

developers of new foods (in this 

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Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7275 

document food refers to both human 

food and animal feed) have a 

responsibility to ensure that the foods 

they offer to consumers are safe and are 

in compliance with all requirements of 

the act (57 FR 22984 at 22985). 

FDA has long regarded it to be a 

prudent practice for producers who use 

biotechnology in the manufacture or 

development of foods and food 

ingredients to work cooperatively with 

FDA to ensure that products derived 

through biotechnology are safe and 

comply with all applicable legal 

requirements. Consequently, FDA 

instituted a voluntary consultation 

process with industry. The guidance on 

Consultation Procedures: From New 

Plant Varieties (originally published in 

1996 and revised October 1997; the 

updated version is available on FDA’s 

Web site at http://www.fda.gov/ 

FoodGuidances) fosters communication 

by encouraging developers to submit to 

FDA their evaluation of the food safety 

of their new plant variety. Such 

communication will help to ensure that 

any potential food safety issues 

regarding a new plant variety are 

resolved during development, and will 

help to ensure that all market entry 

decisions by the industry are made 

consistently and in full compliance with 

the standards of the act. 

Description of Respondents: 

Respondents to this collection of 

information include developers of new 

plant varieties intended for food use. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity FDA Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Initial consultation None 20 2 40 4 160 

Final consultation FDA 3665 12 1 12 150 1,800 

Total 1,960 

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

A. Initial Consultations 

Initial consultations are generally a 

one-time burden, although a developer 

might return more than once to discuss 

additional issues before submitting a 

final consultation. As noted in its 

guidance to industry, FDA encourages 

developers to consult early in the 

development phase of their products, 

and as often as necessary. Historically, 

firms developing a new bioengineered 

plant variety intended for food use have 

generally initiated consultation with 

FDA early in the process of developing 

such a variety, even though there is no 

legal obligation for such consultation. 

These consultations have served to 

make FDA aware of foods and food 

ingredients before these products are 

distributed commercially, and have 

provided FDA with the information 

necessary to address any potential 

questions regarding the safety, labeling, 

or regulatory status of the food or food 

ingredient. As such, these consultations 

have provided assistance to both 

industry and the agency in exercising 

their mutual responsibilities under the 

act. 

Generally, for an initial consultation, 

a developer requests a meeting by 

sending FDA a letter with an agenda. A 

mutually convenient time is arranged 

and the developer comes to discuss 

their product. In preparation for a 

meeting, a developer might prepare 

written materials or a slide presentation 

to discuss their product under 

development. A meeting between the 

developer and FDA typically lasts 

between 1 and 2 hours. As a result of 

such a meeting, FDA establishes a file 

called a biotechnology notification file, 

or BNF, to collect all documentation 

and communication regarding the 

bioengineered plant. For example, FDA 

typically places information such as the 

developer’s letter, agenda, and any 

written materials (such as copies of a 

slide presentation) in a BNF, as well as 

any memorandum FDA prepares as a 

record of the meeting. FDA has not 

issued any recommendations as to the 

format for these types of materials (e.g., 

there is no form associated with 

requesting a meeting). 

Depending on the introduced trait, the 

experience the developer has had with 

the kind of modification being 

considered, and their familiarity with 

the consultation procedures, a 

developer might choose to do a final 

consultation without an initial 

consultation. 

B. Final Consultations 

Final consultations are a one-time 

burden. At some stage in the process of 

research and development, a developer 

will have accumulated the information 

that the developer believes is adequate 

to ensure that food derived from the 

new plant variety is safe and that it 

demonstrates compliance with the 

relevant provisions of the act. The 

developer will then be in a position to 

conclude any ongoing consultation with 

FDA. The developer submits to FDA a 

summary of the safety and nutritional 

assessment that has been conducted 

about the bioengineered food that is 

intended to be introduced into 

commercial distribution. FDA evaluates 

the submission to ensure that all 

potential safety and regulatory questions 

have been addressed. FDA has recently 

developed a form that prompts a 

developer to include certain elements in 

the final consultation in a standard 

format. New Form FDA 3665 is entitled 

‘‘Final Consultation For Food Derived 

From a New Plant Variety 

(Biotechnology Final Consultation).’’ 

The form, and elements that would be 

prepared as attachments to the form, can 

be submitted in electronic format. 

The summary information of the 

safety and nutritional assessment for a 

new plant variety submitted to FDA (on 

the form and in attachments to the form) 

includes the following information: 

• The name of the bioengineered food 

and the crop from which it is derived; 

• A description of the various 

applications or uses of the 

bioengineered food, including animal 

feed uses; 

• Information concerning the sources, 

identities, and functions of introduced 

genetic material; 

• Information on the purpose or 

intended technical effect of the 

modification, and its expected effect on 

the composition or characteristic 

properties of the food or feed; 

• Information concerning the identity 

and function of expression products 

encoded by the introduced genetic 

material, including an estimate of the 

concentration of any expression product 

in the bioengineered crop or food 

derived therefrom; 

• Information regarding any known or 

suspected allergenicity and toxicity of 

expression products and the basis for 

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7276 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

concluding that foods containing the 

expression products can be safely 

consumed; 

• Information comparing the 

composition or characteristics of the 

bioengineered food to that of food 

derived from the parental variety or 

other commonly consumed varieties of 

the same crop with special emphasis on 

important nutrients, and toxicants that 

occur naturally in the food; 

• A discussion of the available 

information that addresses whether the 

potential for the food derived from a 

bioengineered plant to induce an 

allergic response has been altered by the 

genetic modification; and 

• Any other information relevant to 

the safety and nutritional assessment of 

the bioengineered food. 

In 2001, FDA contacted 5 firms that 

had made 1 or more biotechnology 

consultation submissions under the 

1996 procedures. FDA asked each of 

these firms for an estimate of the hourly 

burden to prepare a submission under 

the voluntary biotechnology 

consultation process. Three of these 

firms subsequently provided the 

requested information. Based on this 

information, FDA estimated that the 

average time to prepare a submission for 

final consultation under the 1996 

procedures is 150 hours (69 FR 68379 at 

68381). The availability of the form, and 

the opportunity to provide the 

information in electronic format, could 

reduce this estimate. However, as a 

conservative approach for the purpose 

of this analysis, FDA is assuming that 

the availability of the form and the 

opportunity to submit the information 

in electronic format will have no effect 

on the average time to prepare a 

submission for final consultation under 

the 1996 procedures. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3028 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0070] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Agreement for 

Shipment of Devices for Sterilization 

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 notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection requirements 

relating to shipment of nonsterile 

devices that are to be sterilized 

elsewhere or are shipped to other 

establishments for further processing, 

labeling, or repacking. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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. 

Agreement for Shipment of Devices for 

Sterilization—21 CFR 801.150(e) (OMB 

Control Number 0910–0131)—Extension 

Under sections 501(c) and 502(a) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 351(c) and 

352(a)), nonsterile devices that are 

labeled as sterile but are in interstate 

transit to a facility to be sterilized are 

adulterated and misbranded. FDA 

regulations in § 801.150(e) (21 CFR 

801.150(e)) establish a control 

mechanism by which firms may 

manufacture and label medical devices 

as sterile at one establishment and ship 

the devices in interstate commerce for 

sterilization at another establishment, a 

practice that facilitates the processing of 

devices and is economically necessary 

for some firms. Under § 801.150(e)(1), 

manufacturers and sterilizers may sign 

an agreement containing the following: 

(1) Instructions for maintaining 

accountability of the number of units in 

each shipment; (2) acknowledgment that 

the devices that are nonsterile are being 

shipped for further processing; and (3) 

specifications for sterilization 

processing. 

This agreement allows the 

manufacturer to ship misbranded 

products to be sterilized without 

initiating regulatory action and provides 

FDA with a means to protect consumers 

from use of nonsterile products. 

During routine plant inspections, FDA 

normally reviews agreements that must 

be kept for 2 years after final shipment 

or delivery of devices (§ 801.150(a)(2)). 

The respondents to this collection of 

information are device manufacturers 

and contact sterilizers. 

FDA estimates the burden of this 

collection of information as follows: 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES