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 The draft guidance, when 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draft guidance by July 27, 2009.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on the draft guidance to the Division of 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draft guidance to http:// 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access to the draft guidance.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a draft guidance entitled ‘‘Guidance for 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 The draft guidance is intended to 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
Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices 27805 

This notice is corrected as follows: On 

page 26704 first column, under 

SUMMARY, the Web site should read: 

http://wwwn.cdc.gov/publiccomments/. 

Dated: June 4, 2009. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–13694 Filed 6–10–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences; Initial Review 

Group Minority Programs Review, 

Subcommittee B. 

Date: July 9–10, 2009. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, Bethesda, MD 20814. 

Contact Person: Rebecca H. Johnson, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN18C, Bethesda, 

MD 20892. 301–594–2771. 

Johnsonrhnigms.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: June 4, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13757 Filed 6–10–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; MBRS SCORE. 

Date: July 9, 2009. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN12, 45 Center 

Drive, Bethesda, MD 20892 (Telephone 

Conference Call) 

Contact Person: Arthur L. Zachary, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN–12, Bethesda, 

MD 20892, (301) 594–2886, 

zacharya@nigms.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: June 4, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13758 Filed 6–10–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

Coordinating Center for Health 

Promotion (BSC, CCHP) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting of the 

aforementioned committee: 

Time and Date: 8:30 a.m.–5 p.m., July 1, 

2009. 

Place: CDC, 1825 Century Boulevard, NE., 

Room 1042, Atlanta, Georgia 30345. 

Status: Open to the public, limited only by 

the space available. The meeting room 

accommodates approximately 75 people. 

Purpose: This BSC is charged with 

providing advice and guidance to the 

Secretary of Health and Human Services, the 

Director of CDC, and the Director of CCHP 

concerning strategies and goals for the 

programs and research within the National 

Center on Birth Defects and Developmental 

Disabilities and the National Center for 

Chronic Disease Prevention and Health 

Promotion. 

Matters To Be Discussed: The agenda will 

include a review and discussion of charges 

to the BSC Work Groups. The Work Group 

projects include strategic planning and 

procedures for future external peer review of 

programs in the National Center on Birth 

Defects and Developmental Disabilities, and 

the National Center for Chronic Disease 

Prevention and Health Promotion. The BSC 

will also discuss results of its review of the 

National Center for Chronic Disease 

Prevention and Health Promotion as an 

organizational unit at CDC. 

Providing Oral or Written Comments: It is 

the policy of the BSC, CCHP to provide a 

brief period for oral public comments. In 

general, each individual or group requesting 

to make an oral presentation will be limited 

to a total time of five minutes if time permits. 

Contact Person for Additional Information: 

Karen Steinberg, PhD, Senior Science Officer, 

Coordinating Center for Health Promotion, 

CDC, 4770 Buford Highway, NE., Mailstop E– 

70, Atlanta, Georgia 30341; telephone (404) 

498–6700; fax (404) 498–6880; or via e-mail 

at Karen.Steinberg@cdc.hhs.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register Notices 

pertaining to announcements of meetings and 

other committee management activities, for 

CDC and the Agency for Toxic Substances 

and Disease Registry. 

Dated: June 4, 2009. 

Lorenzo Falgiano, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E9–13692 Filed 6–10–09; 8:45 am] 

BILLING CODE 4163–18–P 


jlentini on PROD1PC65 with NOTICES