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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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 9025 

substantially reduce the paperwork 

burden associated with maintaining 

FDA required records. 

The respondents will be businesses 

and other for-profit organizations, State 

or local governments, Federal Agencies, 

and nonprofit institutions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

11.100 .................................................................................. 4,500 1 4,500 1 4,500 

Total .............................................................................. ........................ ........................ ........................ ........................ 4,500 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

11.10 .................................................................................... 2,500 1 2,500 20 50,000 

11.30 .................................................................................... 2,500 1 2,500 20 50,000 

11.50 .................................................................................... 4,500 1 4,500 20 90,000 

11.300 .................................................................................. 4,500 1 4,500 20 90,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 280,000 

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

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Governmentwide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

Dated: February 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3465 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–0075] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Good Laboratory 

Practice Regulations for Nonclinical 

Studies 

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 good laboratory practice (GLP) for 

nonclinical laboratory studies 

regulations. 

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. 

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