Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 6447

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Part No. of Recordkeepers Annual Frequency per 

Recordkeeping Total Annual Records Hours per Record Total Hours 

113 and 114 7,915 1 7,915 250 1,978,750

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

The reporting burden for §§ 108.25(d) 

and 108.35(d) and (e) is insignificant 

because notification of spoilage, process 

deviation or contamination of product 

in distribution occurs less than once a 

year. Most firms discover these 

problems before the product is 

distributed and, therefore, are not 

required to report the occurrence. To 

avoid double-counting, estimates for 

§§ 108.25(g) and 108.35(h) have not 

been included because they merely 

cross reference recordkeeping 

requirements contained in parts 113 and 

114.

Dated: January 28, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2297 Filed 2–4–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0045]

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 written or electronic 

comments on the collection of 

information by April 8, 2005.

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/

dockets/ecomments. 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:

Karen L. Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

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 our 

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 standard operating procedures 

(SOPs) to assure appropriate use of, and 

precautions for, systems using 

electronic records and signatures: (1) 

Section 11.10 specifies procedures and 

controls for persons who use closed 

systems to create, modify, maintain, or 

transmit electronic records; (2) section 

11.30 specifies procedures and controls 

for persons who use open systems to 

create, modify, maintain, or transmit 

electronic records; (3) section 11.50 

specifies procedures and controls for 

persons who use electronic signatures; 

and (4) section 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 SOPs, 

validation, and certification. The agency 

anticipates the use of electronic media 

will 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:

6448 Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency 

per Response 

Total Annual Responses Hours per Response Total Hours 

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

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 of 

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours 

11.10 2,500 1 2,500 20 45,000

11.30 2,500 1 2,500 20 45,000

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

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

Total 270,000

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

Dated: February 1, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2298 Filed 2–4–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003N–0312] 

Animal Feed Safety System: A 

Comprehensive Risk-Based Safety 

Program for the Manufacture and 

Distribution of Animal Feeds; Notice of 

Public Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to discuss our progress 

on development of a comprehensive, 

risk-based Animal Feed Safety System 

(AFSS) describing how animal feeds 

(individual ingredients and mixed 

feeds) should be manufactured, 

distributed, and used to minimize risks 

to humans and animals. We are seeking 

comments and assistance in our 

consideration of this safety program to 

effectively minimize the hazards to 

public health posed by animal feed 

products. 

Date and Time: The public meting 

will be held on Tuesday, April 5, 2005, 

from 8 a.m. to 5 p.m., and Wednesday, 

April 6, 2005, from 8 a.m. to 12:15 p.m. 

You may submit written or electronic 

comments at any time, but they would 

be most helpful if received on or before 

March 4, 2005. 

Location: The public meeting will be 

held at The Crowne Plaza, 655 North 

108th Ave., Omaha, NE 68154, 402–

496–0850.

ADDRESSES: You may submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments. You can view comments 

FDA has received on the Internet at 

http://www.fda.gov/ohrms/dockets/. 

Contacts:

For General Information: Zoe Gill, 

Center for Veterinary Medicine (HFV–

226), Food and Drug Administration, 

7519 Standish Pl., Rockville, MD 20855, 

240–453–6867, FAX: 240–453–6882, or 

e-mail: zoe.gill@fda.gov. 

For Information About Registration:

Brenda Boateng, Center for Veterinary 

Medicine (HFV–220), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6850, 

FAX: 240–453–6882, or e-mail: 

brenda.boateng@fda.gov. 

Registration: Registration forms are 

available on the Division of Dockets 

Management Web site at http://

www.accessdata.fda.gov/scripts/oc/

dockets/meetings/meetingdocket.cfm. 

Although there is no registration fee for 

this meeting, registration is required. 

Due to limited meeting space, and to 

permit the agency to adequately prepare 

for the meeting, early registration is 

strongly encouraged. We are asking that 

registration occur by March 11, 2005. 

You may register by telephone, fax, or 

e-mail by contacting Brenda Boateng 

(see Contacts). 

If you need special accommodations 

due to a disability, please contact Toni 

Wooten at 301–595–0796 or by e-mail at 

toni.wooten@fda.gov at least 7 days in 

advance of the meeting. 

Transcripts: You may request a 

transcript of the meeting’s general 

session in writing from the Freedom of 

Information Office (HFI–35), Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 12A–16, Rockville, MD 20857. 

The transcript will not include the 

individual breakout sessions, although 

their summaries will be included in the 

general session transcript. The 

transcript of the public meeting will be 

available after the meeting, at a cost of 

10 cents per page. You may also 

examine the transcript of the meeting at 

the Division of Dockets Management 

(see ADDRESSES) between 9 a.m. and 4 

p.m., Monday through Friday and on 

the CVM Web site at http://

www.fda.gov/cvm.

SUPPLEMENTARY INFORMATION: 

I. Background 

We envision the AFSS as an umbrella 

regulatory program aimed at protecting 

human and animal health, It is intended 

to cover the labeling, production, and 

distribution of all feed ingredients and 

mixed feeds at all stages of manufacture, 

distribution, and use. 

On September 23 and 24, 2003, we 

held a public meeting in Herndon, VA 

to discuss the AFSS. The public meeting 

included active participation of people