28498 Federal Register / Vol. 74, No. 114 / Tuesday, June 16, 2009 / Notices 

Acquisition Regulation, Regulatory 

Secretariat (VPR) will be submitting to 

the Office of Management and Budget 

(OMB) a request to reinstate a 

previously approved information 

collection requirement concerning 

Economic Purchase Quantity—Supplies. 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary; whether it will 

have practical utility; whether our 

estimate of the public burden of this 

collection of information is accurate, 

and based on valid assumptions and 

methodology; ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and ways in 

which we can minimize the burden of 

the collection of information on those 

who are to respond, through the use of 

appropriate technological collection 

techniques or other forms of information 

technology. 

DATES: Submit comments on or before 

August 17, 2009. 

ADDRESSES: Submit comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including suggestions for reducing this 

burden, to: General Services 

Administration, Regulatory Secretariat 

(VPR), 1800 F Street, NW., Room 4041, 

Washington, DC 20405. Please cite OMB 

Control No. 9000–0082, Economic 

Purchase Quantity—Supplies, in all 

correspondence. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Lori Sakalos, Procurement Analyst, 

Contract Policy Division, GSA, (202) 

208–0498. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The provision at 52.207–4, Economic 

Purchase Quantity—Supplies, invites 

offerors to state an opinion on whether 

the quantity of supplies on which bids, 

proposals, or quotes are requested in 

solicitations is economically 

advantageous to the Government. Each 

offeror who believes that acquisitions in 

different quantities would be more 

advantageous is invited to (1) 

recommend an economic purchase 

quantity, showing a recommended unit 

and total price, and (2) identify the 

different quantity points where 

significant price breaks occur. This 

information is required by Public Law 

98–577 and Public Law 98–525. 

B. Annual Reporting Burden 

Respondents: 1,524. 

Responses per Respondent: 25. 

Annual Responses: 38,100. 

Hours per Response: .83. 

Total Burden Hours: 31,623. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (VPR), 1800 F 

Street, NW., Room 4041, Washington, 

DC, 20405, telephone (202) 501–4755. 

Please cite OMB Control No. 9000–0082, 

Economic Purchase Quantity—Supplies, 

in all correspondence. 

Dated: June 9, 2009. 

Al Matera, 

Director, Office of Acquisition Policy. 

[FR Doc. E9–14105 Filed 6–15–09; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0261] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Reporting and Recordkeeping 

Requirements for Reportable Food 

Registry 

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 emergency processing under 

the Paperwork Reduction Act of 1995 

(the PRA). This notice solicits 

comments on the proposed collection of 

information associated with the draft 

guidance document entitled ‘‘Questions 

and Answers Regarding the Reportable 

Food Registry as Established by the 

Food and Drug Administration 

Amendments Act of 2007.’’ The draft 

guidance, when finalized, will assist the 

industry in complying with the 

Reportable Food Registry requirements 

prescribed by the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA). 

DATES: Fax written comments on the 

collection of information by July 16, 

2009. FDA is requesting approval of this 

emergency processing by August 17, 

2009. 

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: 

202–395–6974. 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. 

SUPPLEMENTARY INFORMATION: FDA has 

requested emergency processing of this 

proposed collection of information 

under section 3507(j) of the PRA (44 

U.S.C. 3507(j)) and 5 CFR 1320.13. On 

September 27, 2007, the President 

signed FDAAA into law (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 to establish, within 

FDA, a Reportable Food Registry (the 

Registry); the Registry is to be 

established not later than 1 year after 

the date of enactment (i.e., by 

September 27, 2008). 

To further the development of the 

Registry, section 417 of the act requires 

FDA to establish, also within 1 year 

after the date of enactment (i.e., by 

September 27, 2008), 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. This would permit the agency to 

establish an electronic portal through 

which instances of reportable food may 

be submitted to the agency. However, 

FDA recognized that the MedWatchPlus

Portal would not be implemented in 

time to meet the September 27, 2008, 

deadline for establishing the Reportable 

Food electronic portal and therefore 

announced that it was delaying its 

implementation until spring 2009 (73 

FR 30405; May 27, 2008). 

The agency now expects the system to 

be operational on September 8, 2009. 

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. In 

a notice published in the Federal 

Register of June 11, 2009, FDA 

announced the availability of the draft 

guidance document entitled ‘‘Questions 

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Federal Register / Vol. 74, No. 114 / Tuesday, June 16, 2009 / Notices 28499 

and Answers Regarding the Reportable 

Food Registry as Established by the 

Food and Drug Administration 

Amendments Act of 2007.’’ 

Because this guidance involves a 

collection of information, the PRA is 

implicated. However, the delay 

associated with normal PRA clearance 

procedures can reasonably be 

anticipated to prevent the finalization of 

the agency’s guidance document in 

advance of the launch of the portal on 

September 8, 2009. As a result, given 

the need for immediate action, FDA 

requests emergency processing of this 

collection of information request. 

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. 

Title: Reporting and Recordkeeping 

Requirements for Reportable Food 

Registry 

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. 

The draft guidance restates the 

requirements of section 417 of the act 

and presents FDA’s recommendations 

for complying with section 417 of the 

act. 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 110–85, 

section 1005(a)(4) of FDAAA). To 

further the development of the Registry, 

section 417 of the act requires FDA to 

establish an electronic portal by which 

instances of reportable food must be 

submitted to FDA by responsible parties 

and may be submitted by public health 

officials. 

Responsible parties will be required 

to submit reports regarding instances of 

reportable food via the Reportable Food 

electronic portal established by FDA: 

The MedWatchPlus portal. The 

MedWatchPlus portal is a new electronic 

system for collecting, submitting and 

processing adverse event reports and 

other safety information for all FDAregulated products and includes the 

Reportable Food electronic portal. FDA 

is developing and implementing the 

MedWatchPlus portal in a phased 

fashion. Responsible parties must 

comply with section 417 of the act using 

the Reportable Food electronic portal on 

September 8, 2009. The prohibited act 

provisions of the act related to the 

Registry will also apply on September 8, 

2009. 

Reporting 

Under section 417(d)(1) of the act, the 

‘‘responsible party’’ must submit a 

report to FDA through the Reportable 

Food electronic portal including certain 

information on a reportable food 

(‘‘reportable food report’’). The 

‘‘responsible party’’ is defined in section 

417(a)(1) of the act as a person that 

submits the registration under section 

415(a) of the act (21 U.S.C. 360d(a)) for 

a food facility that is required to register 

under section 415(a), at which such 

article of food is manufactured, 

processed, packed, or held. Persons who 

are required to submit a facility 

registration under section 415 of the act 

are the owner, operator, or agent in 

charge of a domestic or foreign facility 

engaged in manufacturing, processing, 

packing, or holding food for 

consumption in the United States. A 

‘‘reportable food’’ is defined in section 

417(a)(2) of the act 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. 

The MedWatchPlus Portal will provide 

one central point-of-entry for persons 

submitting information to FDA 

regarding the safety of FDA-regulated 

products. The agency believes that 

providing one central point-of-entry will 

better enable persons to submit their 

information to FDA. In addition, 

mandatory reporters will be able to use 

the Internet to access the MedWatchPlus

Portal to report safety concerns about 

human and animal food, thus fulfilling 

the mandatory reporting requirements of 

FDAAA that are the subject of the draft 

guidance. 

In the Federal Register of October 23, 

2008 (73 FR 63153), FDA requested 

public comments on a proposed 

collection of information entitled 

‘‘Electronic Data Collection Using 

MedWatchPlus Portal and Rational 

Questionnaire.’’ In that document, the 

agency calculated the reporting burden 

for reportable food reports. Specifically, 

the agency estimated the number of 

respondents and the total annual 

responses for reportable food based on 

the mandatory and voluntary reports 

recently submitted to FDA that would 

be considered reportable food reports in 

the future (73 FR 63153 at 63156 and 

63157). FDA estimated that it would 

receive 200 to 1,200 reportable food 

reports annually from 200 to 1,200 

mandatory and voluntary users of the 

electronic reporting system. The agency 

based these estimates on the receipt of 

625 voluntary food complaints leading 

to adverse events from January 1, 2008, 

to June 30, 2008, and also on the 206 

and 182 Class 1 Recalls for human food 

that took place in fiscal years 2006 and 

2007, respectively. FDA utilized the 

upper-bound estimate of 1,200 reports 

per year for calculating the reportable 

food reporting burden. FDA estimated 

the reporting burden for a mandatory 

reportable food report to be 0.6 hours, 

for a total burden of 720 hours annually 

(1,200 reports × 0.6 hours = 720 hours). 

FDA estimated the reporting burden for 

a voluntary reportable food report to be 

0.6 hours, for a total burden of 720 

hours annually (1,200 reports × 0.6 

hours = 720 hours). The estimated total 

annual responses are based on initial 

reports and amendments to those 

reports. These burden estimates have 

been submitted to OMB in the proposed 

collection of information entitled 

‘‘Electronic Data Collection Using 

MedWatchPlus Portal and Rational 

Questionnaire,’’ which is currently 

under review (74 FR 23721; May 20, 

2009). 

In addition to the burden estimates 

submitted to OMB for approval, the 

agency has subsequently determined 

that there will be additional reporting 

burdens associated with the Registry 

requirements of FDAAA. Specifically, 

FDA may require the responsible party 

to notify the immediate previous source 

and/or immediate subsequent recipient 

of the reportable food (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 and/or immediate subsequent 

recipient of the reportable food (section 

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28500 Federal Register / Vol. 74, No. 114 / Tuesday, June 16, 2009 / Notices 

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

act). We estimate these reporting 

burdens in the following paragraphs. 

Notification to the immediate 

previous source and immediate 

subsequent recipient 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 previously mentioned 

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 

section 417(d)(6)(B) or (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 section 

417(d)(6)(B) or (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). 

FDA estimates that notifying the 

immediate previous recipient will take 

0.6 hours per reportable food and 

notifying the immediate subsequent 

recipient 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 and/or 

immediate subsequent recipient. 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). 

FDA estimates that all mandatory 

reports will require that the immediate 

previous source and subsequent 

recipient be notified. We do not expect 

that this notification burden will apply 

to voluntary reporters of reportable 

foods. Therefore, the total estimated 

burden of notifying the immediate 

previous source and immediate 

subsequent recipient 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 × 0.6 hours) + (1,200 × 

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

× 0.6 hours). FDA’s utilization of an 

upper-bound estimate of 1,200 reports 

and 0.6 hours per report is likely an 

overestimate of the number of reports 

that may be received and an 

overestimate of the time necessary to 

notify 1 immediate previous source and 

1 immediate subsequent recipient. 

However, these overestimates may be 

justified because FDA cannot know how 

often multiple immediate previous 

sources or immediate subsequent 

recipients may need to be notified for 

each reportable food event. FDA 

requests comment on these burden 

estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response 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 or operating and maintenance costs associated with this collection of information. 

Recordkeeping 

The agency has determined that there 

will be recordkeeping burdens 

associated with FDAAA. 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 a similar ‘‘per event’’ 

type of recordkeeping for food and 

cosmetics derived from cattle materials. 

For that recurring recordkeeping 

burden, which involves sending, 

verifying, and storing documents 

regarding shipments of cattle material 

used in human food and cosmetics, we 

estimated that the recurring 

recordkeeping burden would be about 

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Federal Register / Vol. 74, No. 114 / Tuesday, June 16, 2009 / Notices 28501 

15 minutes per week (71 FR 59653 at 

59667; October 11, 2006). 

The annual recordkeeping burden for 

mandatory reports and their associated 

notifications is thus estimated to be 300 

hours (1,200 × 0.25 hours). 

We do not expect that records will 

always be kept in relation to voluntary 

reporting, nor is any such recordkeeping 

required by section 417 of the act. 

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 

× 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 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. 

The draft 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. 

Dated: June 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14048 Filed 6–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; NIH Intramural Research 

Training Program Applications 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Office of the Director, the National 

Institutes of Health (NIH) will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection 

Title: NIH Intramural Research 

Training Program Applications. 

Type of Information Collection 

Request: Revision/OMB No. 0925–0299; 

8/31/2009. 

Need and Use of Information 

Collection: The proposed information 

collection activity is for the purpose of 

collecting applicant data for Training 

Fellowships in the NIH Intramural 

Research Program. This information 

must be submitted in order to receive 

due consideration for a fellowship and 

will be used to determine the eligibility 

and quality of potential awardees. 

Frequency of Response: On occasion. 

Affected Public: Individuals seeking 

intramural training opportunities and 

references for these individuals. 

Type of Respondents: Postdoctoral, 

predoctoral, postbaccalaureate, 

technical, clinical, and student IRTA 

applicants. 

There are no capital costs, operating 

costs, and/or maintenance costs to 

report. 

Type of respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours 

requested 

Postdoctoral ................................................................................................. 3,424 2 .00 1 .00 6,848 

Predoctoral ................................................................................................... 1,458 1 .00 1 .00 1,458 

Postbaccalaureate ....................................................................................... 4,750 1 .00 1 .00 4,750 

Technical ...................................................................................................... 233 1 .00 1 .00 233 

Clinical ......................................................................................................... 400 1 .00 1 .00 400 

Student ......................................................................................................... 14,334 1 .00 1 .00 14,334 

All categories (Race/Gender/Ethnicity survey) ............................................ 4,307 1 .00 0 .25 1,077 

References for all categories ....................................................................... 38,725 1 .00 1 .00 38,725 

Total ...................................................................................................... 67,631 1 .125 0 .90625 67,825 

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