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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9024 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 

immediately halt a specific product 

from entering the United States. 

In the Federal Register of November 

4, 2010 (75 FR 67981), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the revised reporting 

burden of this collection of information 

as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA imported products Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Non-Tobacco (approved by OMB 09/01/2009) ................... 3,406 1,089 3,709,134 .14 519,279 

Tobacco (new estimated burden) ........................................ 200 68 13,600 .14 1,904 

Total .............................................................................. ........................ ........................ ........................ ........................ 521,183 

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

Dated: February 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3466 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–2011–N–0076] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Electronic 

Records; Electronic Signatures 

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 provisions 

relating to FDA’s electronic records and 

electronic signatures. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 18, 2011. 

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. 

Electronic Records; Electronic 

Signatures—21 CFR Part 11 (OMB 

Control Number 0910–0303)—Extension 

FDA regulations in part 11 (21 CFR 

part 11) provide criteria for acceptance 

of electronic records, electronic 

signatures, and handwritten signatures 

executed to electronic records as 

equivalent to paper records. Under these 

regulations, records and reports may be 

submitted to FDA electronically 

provided the Agency has stated its 

ability to accept the records 

electronically in an Agency-established 

public docket and that the other 

requirements of part 11 are met. 

The recordkeeping provisions in part 

11 (§§ 11.10, 11.30, 11.50, and 11.300) 

require the following standard operating 

procedures to assure appropriate use of, 

and precautions for, systems using 

electronic records and signatures: 

(1) § 11.10 specifies procedures and 

controls for persons who use closed 

systems to create, modify, maintain, or 

transmit electronic records; (2) § 11.30 

specifies procedures and controls for 

persons who use open systems to create, 

modify, maintain, or transmit electronic 

records; (3) § 11.50 specifies procedures 

and controls for persons who use 

electronic signatures; and (4) § 11.300 

specifies controls to ensure the security 

and integrity of electronic signatures 

based upon use of identification codes 

in combination with passwords. The 

reporting provision (§ 11.100) requires 

persons to certify in writing to FDA that 

they will regard electronic signatures 

used in their systems as the legally 

binding equivalent of traditional 

handwritten signatures. 

The burden created by the 

information collection provision of this 

regulation is a one-time burden 

associated with the creation of standard 

operating procedures, validation, and 

certification. The Agency anticipates the 

use of electronic media will 

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