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

Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7277 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

801.150(e) 90 20 1,800 4 7,200 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours Total Operating & Maintenance Costs 

801.150(a)(2) 90 20 1,800 0.5 900 $55,800 

1There are no capital costs associated with this collection of information. 

FDA’s estimate of the reporting 

burden is based on actual data obtained 

from industry over the past several years 

where there are approximately 90 firms 

subject to this requirement. It is 

estimated that each of these firms on the 

average prepares 20 written agreements 

each year. This estimate varies greatly, 

from 1 to 100, because some firms 

provide sterilization services on a part 

time basis for only one customer while 

others are large facilities with many 

customers. The average time required to 

prepare each written agreement is 

estimated to be four hours. This 

estimate varies depending on whether 

the agreement is the initial agreement or 

an annual renewal, on the format each 

firm elects to use, and on the length of 

time required to reach agreement. The 

estimate applies only to those portions 

of the written agreement that pertain to 

the requirements imposed by this 

regulation. The written agreement 

generally also includes contractual 

agreements that are a customary and 

usual business practice. On the average, 

the total annual recordkeeping burden is 

7,200 hours (90 firms x 20 agreements 

x 4 hours). 

The recordkeeping requirements of 

§ 801.150(a)(2) consist of making copies 

and maintaining the actual reporting 

requests which were required under the 

reporting section of this collection. To 

fulfill this requirement, FDA estimates it 

will take about 30 minutes to copy each 

package, for a total of 900 recordkeeping 

hours and includes $55,800 operating 

and maintenance costs. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3027 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–0055] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on How to Submit a Protocol 

Without Data in Electronic Format to 

the Center for Veterinary Medicine 

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 

the reporting requirements for the 

information collection activity 

‘‘Guidance for Industry on How to 

Submit a Protocol Without Data in 

Electronic Format to the Center for 

Veterinary Medicine.’’ 

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 the 

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, 

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. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES