Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8959 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

60 1 60 1 .0 60 .0 

Total 60 .0 

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

The study will involve about 60 

respondents and take approximately 1 

hour each to complete. These estimates 

are based on the contractor’s extensive 

experience with mental models 

research. 

Dated: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3912 Filed 2–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0083] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed; Animal Proteins Prohibited in 

Ruminant Feed 

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 recordkeeping requirements for this 

collection of information concerning 

substances prohibited from use in 

animal food or feed and animal proteins 

prohibited in ruminant feed. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 27, 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, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., P150– 

400B, Rockville, MD 20850, 301–827– 

1472. 

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. 

Substances Prohibited From Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed—21 CFR 

589.2000(e)(1)(iv) (OMB Control 

Number 0910–0339)—Extension 

This information collection was 

established because epidemiological 

evidence gathered in the United 

Kingdom suggested that bovine 

spongiform encephalopathy (BSE), a 

progressively degenerative central 

nervous system disease, is spread to 

ruminant animals by feeding protein 

derived from ruminants infected with 

BSE. This regulation places general 

requirements on persons that 

manufacture, blend, process, and 

distribute products that contain or may 

contain protein derived from 

mammalian tissue, and feeds made from 

such products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Records Total Hours 

589.2000(e)(1)(iv) 400 1 400 14 5,600 

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


sroberts on DSKD5P82C1PROD with NOTICES
8960 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

Dated: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3911 Filed 2–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0501] 

Agency Information Collection 

Activities; Submission for Office and 

Management Budget Review; 

Comment Request; Third Party 

Disclosure and Recordkeeping 

Requirements for Reportable Food 

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 29, 

2010. 

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 0910–0643. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management (P150–400B), Food and 

Drug Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–796–3793 

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. 

Third Party Disclosure and 

Recordkeeping Requirements for 

Reportable Food—21 U.S.C. 350f (OMB 

Control Number 0910–0643)—Extension 

On September 27, 2007, the President 

signed into law the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Public Law 110–85). 

Section 1005 of FDAAA amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) by creating a new section 417 

(21 U.S.C. 350f), among other things. 

Section 417 of the act requires the 

Secretary of Health and Human Services 

(the Secretary) to establish within the 

Food and Drug Administration (FDA) a 

Reportable Food Registry (the Registry). 

The Secretary has delegated to the 

Commissioner of FDA the responsibility 

for administering the act, including 

section 417. 

Section 417 of the act defines 

‘‘reportable food’’ as an ‘‘article of food 

(other than infant formula) for which 

there is a reasonable probability that the 

use of, or exposure to, such article of 

food will cause serious adverse health 

consequences or death to humans or 

animals.’’ (section 417(a)(2) of the act). 

Section 417 of the act requires FDA to 

establish an electronic portal (the 

Reportable Food electronic portal) by 

which instances of reportable food must 

be submitted to FDA by responsible 

parties and may be submitted by public 

health officials. FDA made the decision 

that the most efficient and cost effective 

means to implement the requirements of 

section 417 of the act relating to the 

Registry was to utilize the business 

enterprise system currently under 

development within the agency: The 

MedWatchPlus Portal. The electronic 

portal became operational on September 

8, 2009. The collection of information 

associated with the submission of 

reportable food reports to FDA using the 

MedWatchPlus electronic portal has 

been approved under OMB Control No. 

0910–0645. 

In addition, section 1005(f) of FDAAA 

required FDA to issue guidance to 

industry about submitting reports 

through the electronic portal of 

instances of reportable food and 

providing notifications to other persons 

in the supply chain of such article of 

food. FDA issued guidance containing 

questions and answers relating to the 

requirements under section 417 of the 

act, including (1) How, when and where 

to submit reports to FDA; (2) who is 

required to submit reports to FDA; (3) 

what is required to be submitted to 

FDA; and (4) what may be required 

when providing notifications to other 

persons in the supply chain of an article 

of food. The agency announced the 

availability of the guidance document 

titled ‘‘Questions and Answers 

Regarding the Reportable Food Registry 

as Established by the Food and Drug 

Administration Amendments Act of 

2007,’’ on September 9, 2009 (74 FR 

46434). The guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 

question 28 of the guidance have been 

approved under OMB Control No. 0910– 

0249. 

Section 417 of the act established 

third party disclosure and 

recordkeeping burdens associated with 

the Reportable Food Registry. 

Specifically, FDA may require the 

responsible party to notify the 

immediate previous source(s) and/or 

immediate subsequent recipient(s) of 

the reportable food (sections 

417(d)(6)(B)(i) and 417(d)(6)(B)(ii) of the 

act). Similarly, FDA may also require 

the responsible party that is notified 

(i.e., the immediate previous source 

and/or immediate subsequent recipient) 

to notify their own immediate previous 

source(s) and/or immediate subsequent 

recipient(s) of the reportable food 

(sections 417(d)(7)(C)(i) and 

417(d)(7)(C)(ii) of the act). 

Notification to the immediate 

previous source(s) and immediate 

subsequent recipient(s) of the article of 

food may be accomplished by electronic 

communication methods such as e-mail, 

fax or text messaging or by telegrams, 

mailgrams, or first class letters. 

Notification may also be accomplished 

by telephone call or other personal 

contacts, but FDA recommends that 

such notifications also be confirmed by 

one of the above methods and/or 

documented in an appropriate manner. 

FDA may require that the notification 

include any or all of the following data 

elements: (1) The date on which the 

article of food was determined to be a 

reportable food; (2) a description of the 

article of food including the quantity or 

amount; (3) the extent and nature of the 

adulteration; (4) the results of any 

investigation of the cause of the 

adulteration if it may have originated 

with the responsible party, if known; (5) 

the disposition of the article of food, 

when known; (6) product information 

typically found on packaging including 

product codes, use-by dates, and the 

names of manufacturers, packers, or 

distributors sufficient to identify the 

article of food; (7) contact information 

for the responsible party; (8) contact 

information for parties directly linked in 

the supply chain and notified under 

sections 417(d)(6)(B) or 417(d)(7)(C) of 

the act, as applicable; (9) the 

information required by FDA to be 

included in the notification provided by 

the responsible party involved under 

sections 417(d)(6)(B) or 417(d)(7)(C) of 

the act or required to report under 

section 417(d)(7)(A) of the act; and (10) 

the unique number described in section 

417(d)(4) of the act. (sections 

417(d)(6)(B)(iii)(I), 417(d)(7)(C)(iii)(I), 

and 417(e) of the act). FDA may also 

require that the notification provide 

information about the actions that the 


sroberts on DSKD5P82C1PROD with NOTICES