29350 Federal Register / Vol. 75, No. 100 / Tuesday, May 25, 2010 / Notices 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Healthy Homes and Lead Poisoning 

Surveillance System (HHLPSS)—New— 

National Center for Environmental 

Health (NCEH) and Agency for Toxic 

Substances and Disease Registry 

(ATSDR)/Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The overarching goal of the Healthy 

Homes and Lead Poisoning Surveillance 

System (HHLPSS) is to establish 

Healthy Homes Surveillance Systems at 

the state and national levels. Currently, 

40 state and local Childhood Lead 

Poisoning Prevention Programs (CLPPP) 

report information (e.g., presence of lead 

paint, age of housing, and type of 

housing) to CDC via the National Blood 

Lead Surveillance System (NBLSS) 

(OMB No. 0920–0337, exp. 1/31/2012). 

The addition of a new panel of housing 

questions would help to provide a more 

comprehensive picture of housing stock 

in the United States and potentially 

modifiable risk factors. 

The objectives for developing this 

system are two-fold. First, the program 

would like to use surveillance data to 

estimate the extent of housing-related 

injuries and asthma. This is important 

because it will allow the program to 

systematically track the management 

and follow-up of those residents with 

these health outcomes. 

The next objective for the 

development of this system is to 

examine potential housing-related risk 

factors. Childhood lead poisoning is just 

one of many adverse health conditions 

that are related to common housing 

deficiencies. Multiple hazards in 

housing, e.g., mold, vermin, radon and 

the lack of safety devices, continue to 

adversely affect the health of residents. 

It is in the interest of public health to 

expand from a single focus on lead 

poisoning prevention to a coordinated, 

comprehensive, and systematic 

approach to eliminating multiple 

housing-related health hazards. 

HHLPSS builds upon previous efforts 

by the NBLSS. While the earlier NBLSS 

was focused on homes of children less 

than six years old, the new HHLPSS, 

upon approval, will replace the NBLSS 

and will enable flexibility to evaluate all 

homes, regardless of the presence of 

children < age 6 years. 

There is no cost to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN TABLE

Respondents Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hrs.) 

Total burden 

hours 

State and Local Health Departments for Child Surveillance ........................... 40 4 4 640 

Total .......................................................................................................... ........................ ........................ ........................ 640 

Carol Walker, 

Acting Reports Clearance Officer,Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–12538 Filed 5–24–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Miner Safety 

and Health Training—Western United 

States, Request for Application (RFA) 

OH10–001, Initial Review 

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 aforementioned meeting: 

Time and Date: 8:30 a.m.–5 p.m., June 15, 

2010 (Closed). 

Place: Hyatt Regency Pittsburgh 

International Airport, 1111 Airport 

Boulevard, Pittsburgh, Pennsylvania 15231. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5, 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Section 10(d) of Public Law 

92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Miner Safety and Health 

Training Program—Western United States, 

RFA OH10–001.’’ 

Agenda items are subject to change as 

priorities dictate. 

Contact Person For More Information: S. 

Price Connor, PhD, Scientific Review Officer, 

Office of Extramural Programs, CDC, 1600 

Clifton Road, NE., Mailstop E–74, Atlanta, 

Georgia 30333, Telephone (404) 498–2511. 

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 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: May 18, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–12564 Filed 5–24–10; 8:45 am] 

BILLING CODE 4163–18–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 (Edition 2); Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability and 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 100 / Tuesday, May 25, 2010 / Notices 29351 

‘‘Questions and Answers Regarding the 

Reportable Food Registry as Established 

by the Food and Drug Administration 

Amendments Act of 2007 (Edition 2).’’ 

The draft guidance provides information 

to the industry in complying with the 

Reportable Food Registry requirements 

prescribed by the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA). Further, the draft 

guidance addresses inquiries that the 

agency has received through its 

Reportable Food Registry help desk and/ 

or by other means since the 

implementation of the Reportable Food 

Registry on September 8, 2009, and 

provides information on the new Safety 

Reporting Portal. The agency is also 

seeking comments from industry on the 

Reportable Food Registry requirements, 

and specifically on the issue of 

‘‘transfer’’ as discussed in the current 

Edition 1, and draft Edition 2 guidance. 

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 comments on the draft 

guidance before it begins work on the 

final version of the guidance, submit 

electronic or written comments on the 

draft guidance by July 26, 2010. 

ADDRESSES: Submit electronic 

comments on the draft guidance to 

http://www.regulations.gov. 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 

written requests for single copies of the 

draft guidance to the Office of Food 

Defense, Communication and 

Emergency Response (HFS–005), Center 

for Food Safety and Applied Nutrition, 

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 

On September 27, 2007, the President 

signed into law the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA). This law amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) by creating a new section 417 

(21 U.S.C. 350f), Reportable Food 

Registry. Section 417 of the act requires 

the Secretary of Health and Human 

Services (the Secretary) to establish 

within FDA a Reportable Food Registry. 

The congressionally-identified purpose 

of the Reportable Food 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 Secretary has 

delegated to the Commissioner of Food 

and Drugs the responsibility for 

administering the act, including section 

417. To further the development of the 

Reportable Food 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. 

After receipt of reports through the 

electronic portal, FDA is required to 

review and assess the information 

submitted for purposes of identifying 

reportable food, submitting entries to 

the Reportable Food Registry, issuing an 

alert or notification as FDA deems 

necessary, and exercising other existing 

food safety authorities under the act to 

protect the public health. The 

requirements under the Reportable Food 

Registry became effective on September 

8, 2009. 

In the Federal Register of June 11, 

2009, FDA announced the availability of 

a draft guidance entitled ‘‘Questions and 

Answers Regarding the Reportable Food 

Registry as Established by the Food and 

Drug Administration Amendments Act 

of 2007’’ and gave interested parties an 

opportunity to submit comments by July 

27, 2009 (74 FR 27803). The agency 

reviewed and evaluated these comments 

and issued a final guidance on 

September 9, 2009 (74 FR 46434). This 

draft guidance is the second edition of 

that guidance entitled ‘‘Questions and 

Answers Regarding the Reportable Food 

Registry as Established by the Food and 

Drug Administration Amendments Act 

of 2007 (Edition 2)’’ and responds to 

inquiries that the agency has received 

through its Reportable Food Registry 

help desk and/or by other means since 

the implementation of the Reportable 

Food Registry on September 8, 2009, 

and informs industry about the new 

Safety Reporting Portal. The Safety 

Reporting Portal is a joint FDA-National 

Institutes of Health (NIH) system that 

facilitates the process of reporting 

several categories of safety information 

to the FDA and the NIH. As of May 24, 

2010, the Reportable Food electronic 

portal will be a part of the Safety 

Reporting Portal. 

This draft guidance is being issued 

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 the topics discussed. 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. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

this guidance were approved under 

OMB control numbers 0910–0643 and 

0910–0645. This guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collection of information in 21 CFR 

7.46 has been approved under OMB 

control number 0910–0249. 

III. Request for Comments 

In addition, although the industry is 

encouraged to submit comments 

regarding any of the requirements under 

the Reportable Food Registry, the 

agency is seeking comments specifically 

with regard to the meaning of the word 

‘‘transfer’’ as it appears in section 

417(d)(2)(B) of the act. The meaning of 

the word ‘‘transfer’’ in this context was 

discussed in Edition 1 of the guidance 

at Question and Answer numbers 27 

and 28, and in the draft Edition 2 

guidance at Question and Answer 

numbers E.4 and E.5. 

Section 417(d)(2) of the act provides 

an exemption from the requirement that 

a responsible party submit a reportable 

food report. In order for the exemption 

to apply, the adulteration must have 

originated with the responsible party, 

the responsible party must have 

detected the adulteration ‘‘prior to any 

transfer to another person’’ of the article 

of food, and the responsible party must 

have corrected the adulteration or 

destroyed the food. However, Congress 

did not provide a definition for the term 

‘‘transfer’’ as it is used in section 

417(d)(2)(B) of the act. In Edition 1 of 

the guidance at Question and Answer 

numbers 27 and 28, and in the draft 

Edition 2 guidance at Question and 

Answer numbers E.4 and E.5, FDA said 

that a transfer to another person occurs 

when the responsible person releases 

the food to another person. In this 

document, FDA is asking for comment 

on whether this interpretation of the 

term ‘‘transfer’’ is appropriate, and if not, 


srobinson on DSKHWCL6B1PROD with NOTICES
29352 Federal Register / Vol. 75, No. 100 / Tuesday, May 25, 2010 / Notices 

what other interpretations of the term 

‘‘transfer’’ as it is used in section 

417(d)(B)(2) of the act would be more 

appropriate. Specifically, we are 

requesting comment on whether the 

interpretation of the term ‘‘transfer’’ 

should be dependent upon possession 

of the food, whether the interpretation 

should be dependent on ownership of 

the food, or whether there are other 

interpretations we should consider, 

such as a combination of possession 

and/or ownership. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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/FoodGuidances or http:// 

www.regulations.gov. 

Dated: May 19, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–12456 Filed 5–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0241] 

Draft Guidance for Industry on Data 

Elements for Submission of Veterinary 

Adverse Event Reports to the Center 

for Veterinary Medicine; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry #188 entitled ‘‘Data Elements 

for Submission of Veterinary Adverse 

Event Reports to the Center for 

Veterinary Medicine.’’ The purpose of 

this draft guidance is to assist sponsors 

or non-applicants with filling out form 

FDA 1932, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness, Product 

Defect Report,’’ as required by FDA 

regulations. 

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 this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by August 9, 2010. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. 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. 

FOR FURTHER INFORMATION CONTACT: 

Lynn Post, Center for Veterinary 

Medicine (HFV–210), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9191, 

email: Lynn.Post@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #188 

entitled ‘‘Data Elements for Submission 

of Veterinary Adverse Event Reports to 

the Center for Veterinary Medicine.’’ 

The purpose of this draft guidance is to 

assist sponsors or non-applicants with 

filling out Form FDA 1932, in both 

paper and electronic format. Section 

512(l) of the Federal Food, Drug and 

Cosmetic Act (the act) (21 U.S.C. 

360b(l)) and § 514.80(b) (21 CFR 

514.80(b)) require applicants of 

approved new animal drug applications 

(NADAs) and approved abbreviated new 

animal drug applications (ANADAs) to 

report adverse drug experiences and 

product/manufacturing defects. 

This continuous monitoring of 

approved NADAs and ANADAs affords 

the primary means by which FDA 

obtains information regarding potential 

problems with the safety and efficacy of 

marketed approved new animal drugs as 

well as potential product/manufacturing 

problems. Post-approval marketing 

surveillance is important because data 

previously submitted to FDA may no 

longer be adequate, as animal drug 

effects can change over time and less 

apparent effects may take years to 

manifest. An applicant must report 

adverse drug experiences and product/ 

manufacturing defects on Form FDA 

1932, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness, Product 

Defect Report.’’ 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued 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 alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in section 512(l) of the 

act and § 514.80 have been approved 

under OMB Control No. 0910–0645. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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 either 

http://www.fda.gov/AnimalVeterinary/ 

default.htm or http:// 

www.regulations.gov. 

Dated: May 19, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–12454 Filed 5–24–10; 8:45 am] 

BILLING CODE 4160–01–S 


srobinson on DSKHWCL6B1PROD with NOTICES