Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices 27803 

Description: The Performance 

Progress Report (SF–PPR) is a set of 

uniform reporting formats used for 

standard reporting on performance 

under grants and cooperative 

agreements. 

In addition to allowing for uniformity 

of information collection, these formats 

will support systematic electronic 

collection and submission of 

information. These formats will provide 

interim and final performance progress 

information as required by OMB 

Circulars A–102 and 2 CFR part 215. 

The SF–PPR consists of a cover page 

and six optional formats. The cover page 

contains identifying data elements and 

a section for a performance narrative. 

Use of the cover page is required, and 

programs may require their respondents 

to submit only this page and/or attach 

a performance narrative. Alternatively, 

programs may opt to require the cover 

page and one or more of the six optional 

formats: Performance Measures, 

Program Indicators, Benchmark 

Evaluations, Table of Activity Results, 

Activity-Based Expenditures, and 

Program/Project Management 

The SF–PPR has been successfully 

piloted at the Administration for 

Children and Families (ACF). All 

discretionary programs (starting with 

FY09 awards) are to submit the SF–PPR 

to the ACF Office of Grants 

Management. Program offices with 

expiring data collections are required to 

migrate to the SF–PPR format. 

Additionally, a number of program 

offices have voluntarily migrated their 

collections to the SF–PPR format in 

anticipation of government-wide 

standardization. ACF, with its Online 

Data Collection tool (OLDC), has 

provided program offices with the 

capability to collect SF–PPR data 

electronically. 

ACF and the Grants Center of 

Excellence (CoE) is sponsoring this 

collection on behalf of the Grants Policy 

Committee, other Federal grant-making 

agencies, and the CoE partners. 

CoE Partners are defined as: 

Corporation for National and 

Community Service, 

Denali Commission, 

Department of State, 

DHHS/Administration on Aging, 

DHHS/Centers for Medicare Services, 

DHHS/Health Research and Services 

Administration, 

DHHS/Indian Health Services, 

DHHS/Office of Public Health Services, 

DOT/Federal Air Administration, 

DOT/Federal Highway Administration, 

DOT/Federal Motor Carrier Safety 

Administration, 

DOT/Federal Railroad Administration, 

DOT/Federal Transport Administration, 

DOT/Pipeline and Hazardous Materials 

Safety Administration, 

Environmental Protection Agency, 

Institute of Museum and Library 

Services, 

Social Security Administration, 

Department of Treasury, 

USDA/Food Safety and Inspection 

Service, 

Veterans Administration. 

The revised burden estimates are 

based on grant projects and awards for 

ACF and its CoE partners for FY2008 as 

reported by internal ACF reporting 

systems and USASpending.gov. 

Respondents: Federal government 

grantees 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Performance Progress Report (SF–PPR) ..................................................... 131,281 1 0 .42 55,138.02 

Cover Page Continuation (SF–PPR–2) ......................................................... 86 1 0 .33 28.38 

Performance Measures (SF–PPR–A) ............................................................ 430 1 0 .75 322.50 

Program Indicators (SF–PPR–B) .................................................................. 8,961 1 3 26,883 

Benchmark Evaluations (SF–PPR–C) ........................................................... 248 1 1 .50 372 

Table of Activity Results (SF–PPR–D) .......................................................... 4,238 1 0 .75 3,178.50 

Activity Based Expenditures (SF–PPR–E) .................................................... 2,616 1 0 .33 863.28 

Program/Project Management (SF–PPR–F) ................................................. 45 1 0 .50 22.50 

Estimated Total Annual Burden 

Hours: 86,808.18 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7245, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: June 8, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–13728 Filed 6–10–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0260] 

Draft Guidance for Industry: Questions 

and Answers Regarding the 

Reportable Food Registry as 

Established by the Food and Drug 

Administration Amendments Act of 

2007; Availability; Announcement of 

Further Delay in Implementation of the 

Food and Drug Administration 

Amendments Act of 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Guidance for Industry: Questions and 


jlentini on PROD1PC65 with NOTICES
27804 Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices 

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). 

FDA is also announcing a further delay 

in the implementation of the Reportable 

Food Registry (the Registry) of FDAAA 

until September 8, 2009, to consider any 

comments received on the draft 

guidance and through the agency’s 

planned outreach initiatives, and to 

allow for further testing of the electronic 

portal for reportable foods. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on the draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by July 27, 2009. 

ADDRESSES: Submit written comments 

on the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

requests for single copies of the draft 

guidance to the Office of Food Defense, 

Communication and Emergency 

Response, Center for Food Safety and 

Applied Nutrition (HFS–005), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: Faye 

Feldstein, Center for Food Safety and 

Applied Nutrition (HFS–005), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–2428. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Guidance for 

Industry: Questions and Answers 

Regarding the Reportable Food Registry 

as Established by the Food and Drug 

Administration Amendments Act of 

2007.’’ The draft guidance is intended to 

assist those parties responsible for 

complying with the Reportable Food 

Registry requirements prescribed by 

FDAAA. 

FDA is issuing this draft guidance as 

a level 1 draft guidance consistent with 

FDA’s good guidance practices 

regulation (21 CFR 10.115). The draft 

guidance, when finalized, will represent 

the agency’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternate approach may be used if such 

approach satisfies the requirements of 

the applicable statutes and regulations. 

II. Notice of Further Delay in 

Implementation 

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, 

and is therefore announcing that the 

implementation of the requirements of 

section 417 of the act will be further 

delayed until September 8, 2009. 

In the interim, FDA strongly 

encourages persons to continue to report 

instances of adulterated food through 

existing mechanisms, such as notifying 

the relevant FDA District office, until 

such time as the Registry and its 

associated electronic portal are fully 

implemented. 

III. Paperwork Reduction Act of 1995 

This draft guidance document 

contains a collection of information that 

requires clearance by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FDA intends to submit the collection of 

information to OMB in the near future 

for emergency processing. At that time, 

the agency will publish a notice in the 

Federal Register soliciting comments on 

the collection of information. 

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. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/Food/Guidance

ComplianceRegulatoryInformation/ 

GuidanceDocuments/default.htm or 

http://www.regulations.gov. 

Dated: June 5, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13614 Filed 6–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Draft Guideline for Prevention of 

Catheter-Associated Urinary Tract 

Infections 2008 [Correction] 

The notice ‘‘Draft Guideline for 

Prevention of Catheter-Associated 

Urinary Tract Infections 2008,’’ was 

published in the Federal Register on 

June 3rd, 2009, (Vol. 74 FR No. 105). 


jlentini on PROD1PC65 with NOTICES