9022 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 

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 

FD&C 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. 

III. 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 FD&C 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 

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 one 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 68381, 

November 24, 2004). 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 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3476 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0248] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Format and Content Requirements for 

Over-the-Counter Drug Product 

Labeling 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Format and Content Requirements for 

Over-the-Counter Drug Product 

Labeling’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 13, 2010 (75 

FR 49495), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0340. The 

approval expires on January 31, 2014. A 

copy of the supporting statement for this 

information collection is available on 

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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 9023 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: February 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

FR Doc. 2011–3475 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0543] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Importer’s Entry 

Notice 

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 March 18, 

2011. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0046. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.Capezutto@fda.hhs.gov. 

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. 

Importer’s Entry Notice—(OMB Control 

Number 0910–0046)—Revision 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) by adding a new chapter 

granting FDA important new authority 

to regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Section 801 of the FD&C Act, as 

amended by the Tobacco Control Act, 

charges the Secretary of Health and 

Human Services (HHS), through FDA, 

with the responsibility of assuring 

foreign origin FDA regulated foods, 

drugs, cosmetics, medical devices, 

radiological health, and tobacco 

products offered for import into the 

United States meet the same 

requirements of the FD&C Act as do 

domestic products, and for preventing 

products from entering the country if 

they are not in compliance. The 

discharge of this responsibility involves 

close coordination and cooperation 

between FDA (headquarters and field 

inspectional personnel) and the U.S. 

Customs Service (USCS), as the USCS is 

responsible for enforcing the revenue 

laws covering the very same products. 

This collection of information was 

approved by OMB on August 10, 2009, 

and received an expiration date of 

August 31, 2012 (ICR Reference Number 

200905–0910–006). However, because 

tobacco products had only recently been 

added to FDA’s listing of regulated 

products when this collection of 

information was approved, the 

approved collection did not reflect 

information regarding tobacco products 

offered for import into and for 

prevention from them from entering the 

United States if they did not meet the 

same requirements of the FD&C Act as 

domestic products. The revision to this 

collection of information expands the 

universe of respondents being regulated 

under the FD&C Act, as amended, to 

include importers of tobacco products. 

In the most recent OMB approval of 

this information collection package, 

FDA noted that in order to make an 

admissibility decision for each entry, 

the Agency needed four additional 

pieces of information that were not 

available from USCS’s system. These 

data elements were the FDA Product 

Code, FDA country of production, 

manufacturer/shipper, and ultimate 

consignee. It was the ‘‘automated’’ 

collection of these four data elements 

for which OMB approval was being 

requested. When this package was sent 

to OMB for approval, FDA construed 

this request as an extension of the prior 

approval of collection of this data via a 

different media, i.e., paper. FDA noted 

that there were additional data elements 

which filers could provide to FDA along 

with other entry-related information. 

Doing so could result in their receiving 

an FDA admissibility decision more 

expeditiously, e.g., the quantity, value, 

and Affirmation(s) of Compliance with 

Qualifier(s). 

At each U.S. port of entry (seaport, 

landport, and airport) where foreignorigin FDA-regulated products are 

offered for import, FDA is notified, 

through Custom’s Automated 

Commercial System (ACS) by the 

importer (or his agent) of the arrival of 

each entry. Following such notification, 

FDA reviews relevant data to ensure the 

imported product meets the standards 

as are required for domestic products, 

makes an admissibility decision, and 

informs the importer and USCS of its 

decision. A single entry frequently 

contains multiple lines of different 

products. FDA may authorize products 

listed on specific lines to enter the 

United States unimpeded, while other 

products in the same entry are to be 

held pending further FDA review/ 

action. 

An important feature developed and 

programmed into FDA’s automated 

system is that all entry data passes 

through a screening criteria module, 

which makes the initial screening 

decision on every entry of foreign-origin 

FDA-regulated product. Almost 

instantaneously after the entry is filed, 

the filer receives FDA’s admissibility 

decision covering each entry line, i.e., 

‘‘MAY PROCEED’’ or ‘‘FDA REVIEW.’’ 

Examples of FDA’s need to further 

review an entry may result from some 

products originating from a specific 

country or manufacturer known to have 

a history of problems, FDA having no 

previous knowledge of the foreign 

manufacturer and/or product, or a 

product import alert may have been 

issued, etc. The system assists FDA 

entry reviewers by notifying them of 

information, such as the issuance of 

import alerts, thus averting the chance 

that such information will be missed in 

their review. 

Since the inception of the interface 

with ACS, FDA’s electronic screening 

criteria program is applied nationwide. 

This eliminates problems such as ‘‘port 

shopping,’’ e.g., attempts to intentionally 

slip products through one FDA port 

when refused by another, or filing 

entries at a port known to receive a high 

volume of entries. Every electronically 

submitted entry line of foreign-origin 

FDA-regulated product undergoes 

automated screening. The screening 

criteria can be set to be as specific or as 

broad as applicable; changes are 

immediately effective. This capability is 

of tremendous value in protecting the 

public in the event there is a need to 

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