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
Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8961 

recipient of the notification shall 

perform and/or any other information 

FDA may require. (sections 

417(d)(6)(B)(iii)(II) and 

417(d)(6)(B)(iii)(III), 417(d)(7)(C)(iii)(II), 

and 417(d)(7)(C)(iii)(III) of the act). 

Section 417(g) of the act requires that 

responsible persons maintain records 

related to reportable foods reports and 

notifications under section 417 of the 

act for a period of 2 years. 

The congressionally identified 

purpose of the Registry is to provide ‘‘a 

reliable mechanism to track patterns of 

adulteration in food [which] would 

support efforts by the Food and Drug 

Administration to target limited 

inspection resources to protect the 

public health’’ (Pubic Law 110–085, 

section 1005(a)(4)). The third party 

disclosure and recordkeeping 

requirements described previously are 

designed to enable FDA to quickly 

identify and track 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. FDA uses the information 

collected to help ensure that such 

products are quickly and efficiently 

removed from the market. 

Description of Respondents: 

Mandatory respondents to this 

collection of information are the 

owners, operators, or agents in charge of 

a domestic or foreign facility engaged in 

manufacturing, processing, packing, or 

holding food for consumption in the 

United States (‘‘responsible parties’’) 

who have information on a reportable 

food. Voluntary respondents to this 

collection of information are Federal, 

State, and local public health officials 

who have information on a reportable 

food. 

In accordance with 5 CFR 1320.8(d), 

in the Federal Register of October 20, 

2009 (74 FR 53746), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received two letters in 

response to the notice before the close 

of the comment period, each containing 

one or more comments. 

(Comment 1) One comment argued 

that FDA underestimated the burden of 

notifying the immediate previous 

source(s) and the immediate subsequent 

recipient(s) of the article of food because 

it underestimated the potential number 

of such sources and recipients that may 

require notification. The comment 

stated that there could be more than 

12,500 different sources for the grain 

portion of a single shipment of finished 

feed, and more than 80 different 

immediate previous sources for the 

other feed ingredients present. 

Similarly, another comment argued that 

FDA underestimated the burden of 

notifying the immediate previous 

source(s) and the immediate subsequent 

recipient(s) of the article of food because 

it assumed only one previous source 

and one subsequent recipient. 

(Response) FDA appreciates the data 

provided in the comment. However, the 

agency notes that the comment did not 

provide any proposed change to the 

burden hours set forth. Thus, FDA has 

not changed the burden hour estimate in 

table 1 of this document. Please note 

that we expect to be able to obtain 

relevant data from the electronic 

reporting system that we can use to 

better estimate the burden of this 

reporting. We also note that this burden 

is imposed by the law itself. The 

reporting to immediate previous 

source(s) and immediate subsequent 

recipient(s) of a reportable food is 

authorized by sections 417(d)(6)(B)(i), 

417(d)(6)(B)(ii), 417(d)(7)(C)(i), and 

417(d)(7)(C)(ii) of the act. FDA has no 

way of knowing how long each supply 

chain is or how many ingredients will 

be involved with each reportable event. 

However, we did attempt to account for 

this reporting. We estimated burdens 

assuming two immediate previous 

sources and two immediate subsequent 

recipients for each of the 1,200 

estimated annual reportable food events. 

(Comment 2) One comment argued 

that FDA underestimated the burden of 

notifying the immediate previous 

source(s) and the immediate subsequent 

recipient(s) of the article of food, 

arguing that the 0.6 hours estimated by 

the agency does not adequately allow 

for recall notification writing, editing, 

review and approval by the notifying 

entity and FDA. The comment estimated 

that it would take a minimum of 4 hours 

to prepare an FDA-approved Class I 

recall notification. The comment further 

argued that recall followup activities 

and communications between the 

affected entity(ies) and the FDA will 

take additional time. 

(Response) FDA disagrees and notes 

that the comment references the Class I 

recall procedures governed by part 7 of 

FDA’s regulations (21 CFR part 7). We 

did not estimate a burden for this 

process because the procedures and the 

associated burden estimates have 

already been approved under OMB 

control number 0910–0249 (FDA Recall 

Regulations, 21 CFR part 7). 

(Comment 3) One comment argued 

that FDA underestimated the burden of 

notifying the immediate previous 

source(s) and the immediate subsequent 

recipient(s) of the article of food because 

it assumed that one form of notification, 

noting that multiple methods of 

notification are typically necessary: Email, facsimile, and postal mail. 

(Response) FDA disagrees. With 

regard to the method of notification for 

the purposes of this information 

collection, as described elsewhere in 

this document, notification 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 

notifications also be confirmed or 

documented in an appropriate manner. 

Multiple forms of notifications are not 

required and, therefore, were not 

included in the burden estimate. 

Third Party Disclosure 

FDA estimates that approximately 

1,200 reportable food events with 

mandatory reporters will occur 

annually. FDA received 625 voluntary 

food complaints leading to adverse 

events from January 1, 2008, to June 30, 

2008, and there were 206 and 182 Class 

1 Recalls for human food in Fiscal Years 

2006 and 2007, respectively. Based on 

these experiences, FDA estimates that 

FDA could receive 200 to 1,200 

‘‘reportable’’ food reports annually from 

200 to 1,200 mandatory and voluntary 

users of the electronic reporting system. 

FDA will utilize the upper-bound 

estimate of 1,200 for these calculations 

(73 FR 63153 at 63157 (October 23, 

2008); 74 FR 23721 at 23727 (May 20, 

2009)). 

FDA estimates that notifying the 

immediate previous source(s) will take 

0.6 hours per reportable food and 

notifying the immediate subsequent 

recipient(s) will take 0.6 hours per 

reportable food. FDA also estimates that 

it will take 0.6 hours for the immediate 

previous source and/or the immediate 

subsequent recipient to also notify their 

immediate previous source(s) and/or 

immediate subsequent recipient(s). The 

agency bases its estimate on its 

experience with mandatory and 

voluntary reports recently submitted to 

FDA that would be considered 

reportable food reports in the future. (73 

FR at 63157). 

Although it is not mandatory under 

FDAAA section 1005 that responsible 

persons notify the sources and 

recipients of instances of reportable 

food, for purposes of the burden 

estimate we are assuming FDA would 

exercise its authority and require such 

notifications in all such instances for 

mandatory reporters. This notification 

burden will not affect voluntary 

reporters of reportable food events. 

Therefore, FDA estimates that the total 


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8962 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

burden of notifying the immediate 

previous source(s) and immediate 

subsequent recipient(s) under sections 

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

417(d)(7)(C)(i) and 417(d)(7)(C)(ii) of the 

act for 1,200 reportable foods will be 

2,880 hours annually (1,200 x 0.6 hours) 

+ (1,200 x 0.6 hours) + (1,200 x 0.6 

hours) + (1,200 x 0.6 hours). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.— ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

of 

Disclosure 

Total Annual 

Disclosures 

Hours per 

Disclosure Total Hours 

Notifying immediate previous source of the article 

of food under section 417(d)(6)(B)(i) of the act 1,200 1 1,200 0.6 720 

Notifying immediate subsequent recipient of the article of food under section 417(d)(6)(B)(ii) of the 

act 1,200 1 1,200 0.6 720 

Notifying immediate previous source of the article 

of food under section 417(d)(7)(C)(i) of the act 1,200 1 1,200 0.6 720 

Notifying immediate subsequent recipient of the article of food under section 417(d)(7)(C)(ii) of the 

act 1,200 1 1,200 0.6 720 

Total 2,880 

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

Recordkeeping 

As noted previously, section 417(g) of 

the act requires that responsible persons 

maintain records related to reportable 

foods reports and notifications under 

section 417 of the act for a period of 2 

years. We estimate that each mandatory 

report and its associated notifications 

will require 30 minutes of 

recordkeeping for the 2-year period, or 

15 minutes per record per year. FDA 

bases its estimate on its experience with 

recordkeeping for food and cosmetics 

derived from cattle materials (71 FR 

59653 at 59667; October 11, 2006). The 

annual recordkeeping burden for 

mandatory reportable food reports and 

their associated notifications is thus 

estimated to be 300 hours (1,200 x 0.25 

hours). 

We do not expect that records will 

always be kept in relation to voluntary 

reportable food reports. Therefore FDA 

estimates that records will be kept for 

600 of the 1,200 voluntary reports we 

expect to receive annually. The 

recordkeeping burden associated with 

voluntary reports is thus estimated to be 

150 hours annually (600 x 0.25 hours). 

The estimated total annual 

recordkeeping burden is shown in table 

2 of this document. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Activity No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records2

Hours per 

Record Total Hours 

Maintenance of reportable food 

records under section 417(g) of 

the act—Mandatory reports 1,200 1 1,200 0.25 300 

Maintenance of reportable food 

records under section 417(g) of 

the act—Voluntary reports 600 1 600 0.25 150 

Total 450 

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

2For purposes of estimating number of records and hours per record, a ‘‘record’’ means all records kept for an individual reportable food by 

the responsible party or a voluntary reporter. 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8963 

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4003 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–0088] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Reporting and 

Recordkeeping Requirements and 

Availability of Sample Electronic 

Products for Manufacturers and 

Distributors of Electronic Products 

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 requirements for 

reporting and recordkeeping, general 

and specific requirements, and the 

availability of sample electronic 

products for manufacturers and 

distributors of electronic products. 

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: 

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. 

Reporting and Recordkeeping 

Requirements and Availability of 

Sample Electronic Products for 

Manufacturers and Distributors of 

Electronic Products (OMB Control 

Number 0910–0025)—Extension 

Under sections 532 through 542 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360ii through 360ss), 

FDA has the responsibility to protect the 

public from unnecessary exposure of 

radiation from electronic products. The 

regulations issued under these 

authorities are listed in title 21 of the 

Code of Federal Regulations, chapter I, 

subpart J, parts 1000 through 1050 (parts 

1002 through 1050). 

Section 532 of the act directs the 

Secretary of the Department of Health 

and Human Services (the Secretary), to 

establish and carry out an electronic 

product radiation control program, 

including the development, issuance, 

and administration of performance 

standards to control the emission of 

electronic product radiation from 

electronic products. The program is 

designed to protect the public health 

and safety from electronic radiation, and 

the act authorizes the Secretary to 

procure (by negotiation or otherwise) 

electronic products for research and 

testing purposes and to sell or otherwise 

dispose of such products. Section 534(g) 

of the act directs the Secretary to review 

and evaluate industry testing programs 

on a continuing basis; and section 

535(e) and (f) of the act directs the 

Secretary to immediately notify 

manufacturers of, and ensure correction 

of, radiation defects or noncompliances 

with performance standards. Section 

537(b) of the act contains the authority 

to require manufacturers of electronic 

products to establish and maintain 

records (including testing records), 

make reports, and provide information 

to determine whether the manufacturer 

has acted in compliance. 

21 CFR parts 1002 through 1010 

specify reports to be provided by 

manufacturers and distributors to FDA 

and records to be maintained in the 

event of an investigation of a safety 

concern or a product recall. 

FDA conducts laboratory compliance 

testing of products covered by 

regulations for product standards in 

parts 1020, 1030, 1040, and 1050. 

FDA details product-specific 

performance standards that specify 

information to be supplied with the 

product or require specific reports. The 

information collections are either 

specifically called for in the act or were 

developed to aid the agency in 

performing its obligations under the act. 

The data reported to FDA and the 

records maintained are used by FDA 

and the industry to make decisions and 

take actions that protect the public from 

radiation hazards presented by 

electronic products. This information 

refers to the identification of, location 

of, operational characteristics of, quality 

assurance programs for, and problem 

identification and correction of 

electronic products. The data provided 

to users and others are intended to 

encourage actions to reduce or eliminate 

radiation exposures. 

FDA uses the following forms to aid 

respondents in the submission of 

information for this information 

collection: 

• FDA Form 2579 ‘‘Report of 

Assembly of a Diagnostic X-Ray System’’ 

• FDA Form 2767 ‘‘Notice of 

Availability of Sample Electronic 

Product’’ 

• FDA Form 2877 ‘‘Declaration for 

Imported Electronic Products Subject To 

Radiation Control Standards’’ 

• FDA Form 3649 ‘‘Accidental 

Radiation Occurrence (ARO)’’ 


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