53746 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

101.14(d)(2) 300,000 1.5 450,000 0.75 337,500 

101.22(i)(4) 25 1 25 1 25 

101.100(d)(2) 1,000 1 1,000 1 1,000 

101.105(t) 100 1 100 1 100 

Total 676,150 

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

TABLE 3—ESTIMATED REPORTING BURDEN1

21 CFR Section/ 

Form No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

101.9(j)(18) and 101.36(h)(2)/ 

Form FDA 3570 10,000 1 10,000 8 80,000 

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

The estimated annual reporting and 

recordkeeping burdens are based on 

agency communications with industry 

and FDA’s knowledge of and experience 

with food labeling and the submission 

of petitions and requests to the agency. 

Where an agency regulation implements 

an information collection requirement 

in the act or the FPLA, only any 

additional burden attributable to the 

regulation has been included in FDA’s 

burden estimate. 

No burden has been estimated for 

those requirements where the 

information to be disclosed is 

information that has been supplied by 

FDA. Also, no burden has been 

estimated for information that is 

disclosed to third parties as a usual and 

customary part of a food producer’s 

normal business activities. Under 5 CFR 

1320.3(c)(2), the public disclosure of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of disclosure to the public 

is not a collection of information. Under 

5 CFR 1320.3(b)(2), the time, effort, and 

financial resources necessary to comply 

with a collection of information are 

excluded from the burden estimate if 

the reporting, recordkeeping, or 

disclosure activities needed to comply 

are usual and customary because they 

would occur in the normal course of 

activities. 

In this request for extension of OMB 

approval under the PRA, FDA is 

combining the burden hours associated 

with OMB control numbers 0910–0395 

(collection entitled ‘‘Food Labeling: 

Nutrition Labeling of Dietary 

Supplements on a ‘Per Day’ Basis’’) and 

0910–0515 (collection entitled ‘‘Food 

Labeling: Trans Fatty Acids in Nutrition 

Labeling’’) with the burden hours 

approved under OMB control number 

0910–0381 (collection entitled ‘‘Food 

Labeling Regulations’’). 

Dated: October 9, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25102 Filed 10–19–09; 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; Proposed Collection; 

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 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 information collection provisions of 

FDA’s third party disclosure and 

recordkeeping requirements for 

reportable food. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 21, 2009. 

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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794, 

Jonnalynn.Capezzuto@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 


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Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53747 

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. 

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 

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.’’ (see 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 

entitled ‘‘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 (see section 

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

(section 417(d)(7)(C)(i) and (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 previous 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 (section 

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

(e) of the act). FDA may also require that 

the notification provide information 

about the actions that the recipient of 

the notification shall perform and/or 

any other information FDA may require 

(section 417(d)(6)(B)(iii)(II), 

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

(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’’ (Public 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 


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53748 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 

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. 

FDA estimates the burden of this 

collection of information as follows: 

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 63153 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 

burden of notifying the immediate 

previous source(s) and immediate 

subsequent recipient(s) under section 

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

and (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). 

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. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Activity 

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records2

Hours per 

Records 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 


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Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53749 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

Activity 

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records2

Hours per 

Records Total Hours 

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. 

Dated: October 13, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25100 Filed 10–19–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0487] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance on 

Informed Consent For In Vitro 

Diagnostic Device Studies Using 

Leftover Human Specimens That Are 

Not Individually Identifiable 

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 

guidance on informed consent for in 

vitro diagnostic device studies using 

leftover human specimens that are not 

individually identifiable. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 21, 2009. 

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, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Guidance on Informed Consent For In 

Vitro Diagnostic Device Studies Using 

Leftover Human Specimens That Are 

Not Individually Identifiable—OMB 

Control Number 0910–0582—Extension 

FDA’s investigational device 

regulations are intended to encourage 

the development of new, useful devices 

in a manner that is consistent with 

public health, safety, and with ethical 

standards. Investigators should have 

freedom to pursue the least burdensome 

means of accomplishing this goal. 

However, to ensure that the balance is 

maintained between product 

development and the protection of 

public health, safety, and ethical 

standards, FDA has established human 

subject protection regulations 

addressing requirements for informed 

consent and institutional review board 

(IRB) review that apply to all FDAregulated clinical investigations 

involving human subjects. In particular, 

informed consent requirements further 

both safety and ethical considerations 

by allowing potential subjects to 

consider both the physical and privacy 

risks they face if they agree to 

participate in a trial. 

Under FDA regulations, clinical 

investigations using human specimens 

conducted in support of premarket 

submissions to FDA are considered 

human subject investigations (see 21 

CFR 812.3(p)). Many investigational 

device studies are exempt from most 

provisions of part 812 (21 CFR part 812), 

Investigational Device Exemptions, 

under § 812.2(c)(3), but FDA’s 

regulations for the protection of human 

subjects (21 CFR parts 50 and 56) apply 

to all clinical investigations that are 

regulated by FDA (see 21 CFR 50.1; 21 

CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and 

21 U.S.C. 360j(g)(3)(D)). 

FDA regulations do not contain 

exceptions from the requirements of 

informed consent on the grounds that 

the specimens are not identifiable or 

that they are remnants of human 

specimens collected for routine clinical 

care or analysis that would otherwise 

have been discarded. Nor do FDA 

regulations allow IRBs to decide 

whether or not to waive informed 


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